Clinical Trial Registry Of India Research Articles

Prevalence of Oral Potentially Malignant Lesions, Tobacco use, and Effect of Cessation Strategies among Solid Waste Management workers in Northern India: a pre-post intervention study

BackgroundIndia bears the highest global burden of oral cancer, despite having an operational tobacco cessation framework. Occupational groups like solid waste management personnel face significant health challenges due to prevalent tobacco use, leading to oral potentially malignant lesions and oral cancer. Enhanced tobacco control strategies are essential for these groups.MethodsA pre-post interventional, community-based study enrolled 1200 municipal workers in Varanasi, India, from July 2022 to August 2023. 858 tobacco users underwent screening and were randomly assigned to one of three interventions: Very Brief Advice, Individual Behavioral Counseling, or Group Behavioral Therapy. Follow-up was conducted one year after the baseline interventions Effectiveness was measured by nicotine dependence reduction using the Fagerstrom Test for Nicotine Dependence (FTND) scores and cessation rates defined as at least 6-month abstinence. Appropriate statistical tests assessed the burden of tobacco use, oral potentially malignant lesions, and pre-post differences in FTND scores within and between groups. A p-value of < 0.05 was considered statistically significant.ResultsMunicipal workers exhibited a high prevalence (71.5%) of smokeless tobacco (SLT) use. One-third (32.9%) of the participants screened positive for oral potentially malignant lesions and oral cancer. Leukoplakia was the most common lesion. Screened positivity correlated with significant nicotine dependence. Among 494 follow-up participants, 47.1% reported a significant reduction in nicotine dependence across all intervention groups. Quade’s ANCOVA indicated significant differences in post-test FTND scores, with individual behavioral counselling showing the greatest reduction. However, no cessation was achieved in any group despite the significant decline in dependence.ConclusionSolid waste management personnel in Varanasi show heightened SLT use and associated oral potentially malignant lesions. The persistent tobacco use in these high-risk occupational populations undermines government tobacco control efforts and highlights the need for robust policy and implementation strategies. The study demonstrated a significant reduction in nicotine dependence following interventions, though tobacco cessation was not achieved. More frequent interventions and addressing quitting barriers—such as cultural norms, lack of awareness, easy accessibility, and adverse working conditions—are crucial. Developing a tailored workplace model to tackle tobacco use in occupational settings may facilitate cessation.Clinical trial registration numberTrial registration Clinical Trials Registry India CTRI/2020/07/026479. Date of registration 10/07/2020.

Improvement in symptoms of anxiety and depression in individuals with type 2 diabetes: retrospective analysis of an intensive lifestyle modification program

BackgroundType 2 diabetes (T2D) is a chronic metabolic disorder that has a notable influence on mental well-being, contributing to elevated morbidity and mortality rates. Depression and anxiety disorders are the most common mental health concerns among patients with T2D worldwide. Therefore, the present study aimed to assess the impact of an online intensive lifestyle intervention (ILI) on mental health outcomes (depression and anxiety) in patients with T2D in India.Materials and methodsThis retrospective pre-post analysis included adult patients (aged > 18 years) diagnosed with T2D who were enrolled in a diabetes management program in India between June 2021 and June 2023. The intervention consisted of lifestyle modifications such as a customized plant-based diet, regular physical activity, psychological support through group and individual therapy, and medical management. Data were extracted from the electronic database of the clinic, including anthropometry, medical history, biochemical parameters, symptoms of depression, and anxiety (assessed using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorders-7 (GAD-7) scale) at the start and end of the six-month intervention period.ResultsOf the 1061 eligible patients (177 with prediabetes), 40.3% were female. The mean age, duration of diabetes, and HbA1c levels were 52 ± 10.4 years, 9.8 ± 7.8 years, and 8 ± 1.7%, respectively. The prevalence of symptoms of depression and anxiety (ranging from mild to severe) was 46% and 44.3%, respectively, which reduced to 28.7% and 29.2%, respectively, post-intervention.ConclusionIntegrated ILI successfully improved the symptoms of anxiety and depression, highlighting the importance of a multidisciplinary approach that includes diet, physical activity, psychological support, and medical management in enhancing mental health outcomes among patients with T2D. Future prospective studies are needed to explore the long-term effects of such interventions and develop effective strategies for promoting mental health in diverse populations.Trial registrationThe study was approved by the Freedom from Diabetes Research Foundation Institutional Ethics Committee (approval number FFDRF/IEC/2024/7) and registered in the Clinical Trials Registry of India (CTRI/2024/03/064596, registered on March 21, 2024).

Homoeopathy vs. conventional primary care in children during the first 24months of life-a pragmatic randomised controlled trial.

Homoeopathy, using conventional medicine as a safety backdrop, was more effective than conventional treatment in preventing sick days, sickness episodes, and respiratory illnesses in the first 24months of life. It necessitated fewer antibiotics and its overall cost was lower. This study supports homoeopathy, using conventional medicine as a safety backdrop, as a safe and cost-effective primary care modality during the first 2years of life. Clinical Trial Registry-India (2018/09/015641). https://ctri.nic.in/Clinicaltrials/login.php What is Known: • Due to their holistic nature, many Complementary and Alternative Medical (CAM) modalities are not readily amenable to assessment by head-to-head RCT for a given Indication. • We propose a pragmatic, RCT comparing homoeopathic with conventional medicineas a system. • Homoeopathic was apparently superior to conventional primary care in preventing sick days, sickness episodes, and respiratory illness episodes and was significantly associated with growth in height but not weight and required fewer antibiotics in children from birth to 24 months of age.

Comparative evaluation of autologous tissue-engineered ocular and oral mucosal tissue grafts- a prospective randomized controlled trial

BackgroundBilateral ocular surface disease resulting from Stevens Johnson Syndrome (SJS) and chemical injuries are visually debilitating and difficult to treat. Ocular surface reconstruction by various means has been reported with variable results. This study addresses an unmet need for a prospective clinical trial comparing the outcomes of transplanting autologous oral and conjunctival epithelial cell constructs on human amniotic membrane by ex vivo tissue engineering.MethodsA prospective, randomized controlled clinical trial was prospectively applied for registration, with the clinical trial registry of India (CTRI), with the approval of the Institute Ethics Committee number IEC/NP-99/11.04.2014 and CTRI No. REF/2018/10/021791, the study also registered with the WHO-recognized trial registry, International Standard Randomised Controlled Trial Number (ISRCTN) registration reference number 45780. The study was conducted to compare clinical outcomes of two different tissue-engineered cell grafts, Cultivated Oral Mucosal Epithelial Transplantation (COMET) and Conjunctival Cultivated Epithelial Transplantation (CCET) for ocular surface reconstruction in patients with bilateral ocular surface disease due to Stevens-Johnson Syndrome or chemical injuries. Fifty patients were enrolled and randomized to either the COMET or CCET group. A uniform pre-op and post-op protocol using standard medications was followed for all patients Parameters assessed at baseline, day 1, 1 week, 2 weeks, 1 month, 2 months, 3 months and 6 months postoperatively included patient comfort, best corrected visual acuity (BCVA), ocular surface status and corneal clarity. The efficacy was measured in terms of improvement of vision, reduction in vascularization, symblepharon and corneal clarity.ResultsIn the study, 50 patients (50 eyes; mean ages of 29 ± 15.86 years and 26.36 ± 10.85 years, respectively; range, 12–65 years) were enrolled, with 25 patients each in the COMET and CCET groups. Out of them, 36% were female and 64% were male; the causes were Steven Johnson syndrome (48), and chemical injury (2). Mean pre-operative BCVA was log MAR 1.73 ± 0.57 for COMET and 1.99 ± 0.33 for the CCET group. Pre-operatively all 50 enrolled patients had opaque corneas pre-operatively, symblepharon that extended to the cornea categorised as grade 3 and corneal vascularization that went beyond the pupil’s boundary into the central zone encluaching on the visual axis. The minimal follow-up time was six months. Following surgery postoperatively, the BCVA considerably improved in the COMET group by 1.51 ± 0.58 compared to the CCET group by 1.91 ± 0.33 at 3 months. BCVA at 6 months was 1.73 ± 0.56 in the COMET group and 1.99 ± 0.31 in the CCET group, which is not statistically significant and comparable to the BCVA before surgery. The corneal clarity was significantly improved in COMET group 25 eye (100%) at 2 month, 3month and 19 eye (76%), 6eye (24%) at 6 months when compared to CCET group 15 eye improved (60%), 9 eyes (36%) not improved and one eye with opaque cornea (4%) at 2 months. 22 eye (88%) had not improved, 2 eye (8%) opaque cornea and 1 eye (4%) improved at 3 months. At 6 months 21 eye (84%) were not improved, 4 eye (16%) eye became opaqued at 6 months. Compared to preoperative conditions, both groups had improved corneal clarity significantly (p > 0.005). Of the 50 patients with grade 3 symblepharon extended to the cornea, were completely resolved 19 (76%) in COMET group when compared to CCET group 22 eye (88%) not improved. Similarly, 19 eye (76%) had a improvement in corneal vascularization when compared to the CCET group not improved 25 eye (100%) at 6months. No adverse event was observed in any of either group during the follow up periods.ConclusionBoth cell types are effective to restore the ocular surface integrity in bilateral ocular surface disease. Whereas COMET is safe and efficacious in terms of improvement of clinical parameters including, BCVA, corneal clarity, reduction in vascularization and preventing the recurrence of symblepharon postoperatively 3months and 6 months. In addition, the CCET group maintained the stability of the ocular surface and had improvement in corneal clarity and a decrease in vascularization at 3 months compared to their pre-operative characteristics.

Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT)

ABSTRACT Background Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available. Methods Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups. Results A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15). Conclusion We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle. Clinical trial registration Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

ANODYNE study: A double-blind randomized trial of greater occipital nerve block of methylprednisolone and lignocaine versus placebo as a transitional preventive treatment for episodic cluster headache.

There is inadequate evidence of the efficacy of greater occipital nerve block (GONB) for the preventive treatment of cluster headaches. We assessed the efficacy and tolerability of GONB injections as a transitional preventive treatment for episodic cluster headaches (ECH). This randomized, double-blind, placebo-controlled, parallel-group trial conducted at GB Pant Institute of Postgraduate Medical Education and Research, New Delhi, India, included ECH patients diagnosed by ICHD-3 criteria, aged 18-65, with one or more attacks per 24 h for seven days before randomization (baseline). ECH patients were either not on preventive medications or on stable doses for at least three months. ECH patients were randomized to receive active GONB (2 ml methylprednisolone (80 mg) and 2 ml lignocaine (2%)) and placebo (4 ml saline injections). Before giving GONB, lignocaine jelly was applied topically to mask the effect of numbness following the GONB. The primary efficacy endpoint was the mean change in weekly attack frequency from baseline to Week 4. Efficacy analyses were performed in a modified intention-to-treat population that included all patients who received at least one injection of GONB and had a follow-up for one week following GONB. The safety analysis included treatment-emergent adverse effects (TEAE) in all patients who received at least one dose of investigational product. The trial was registered with the Clinical Trials Registry of India (CTRI/2021/21/038397). Forty ECH patients were randomized between December 2021 and January 2023. Thirty-nine patients (19 in the active and 20 in the placebo groups) were available for efficacy analysis. The change in weekly attack frequency from baseline to Week 4 was -11.1 (95% CI: -8.5 to -4.4) for the active group compared to -7.7 (95% CI: -11.8 to -9.8) for placebo (mean difference -3.4 (95% CI: -5.2 to -1.7, p < 0.001). We noted TEAE in 18 (90%) of 20 patients who received the active drug and in 18 (90%) of 20 patients who received a placebo (p = 0.38). The common TEAE were local site bleeding and pain, which were mild and transient. No serious adverse events were reported. This study found that GONB with methylprednisolone and lignocaine significantly reduced the weekly attack frequency from baseline to Week 1 through Week 4 in ECH patients compared to a placebo. GONB was well tolerated.

Association of H-reflex parameters and peroneal nerve conduction velocity with dynamic balance and agility in university athletes: a cross-sectional study

Abstract Athletic performance parameters encompass a wide range of physical, physiological, and biomechanical measures that are crucial for evaluating and optimising athletes’ capabilities. There are various intrinsic factors that can contribute to athletic skills, which subsequently impact overall performance. Thus, there is a need to explore significant intrinsic factors associated with athletic parameters, that can provide insights into the physiological mechanisms underlying performance. In this study, we examined the potential relationship of two such intrinsic factors, namely the H-reflex and the peroneal nerve conduction velocity, with athletic skills like dynamic balance and agility. Forty-five university-level athletes of all genders playing for different teams of Jamia Millia Islamia University, New Delhi, India were selected. All athletes underwent tibial H-reflex, peroneal NCV, mSEBT (for dynamic balance), and agility T-test evaluations. The Pearson correlation coefficient was calculated to evaluate the association of nerve function parameters (H-reflex and NCV) with athletic performance parameters (dynamic balance and agility). Results showed that H-reflex amplitude showed a significant negative correlation with both dynamic balance scores (Dominant Leg [DL]: r = −0.321 and ; Non-dominant leg [NDL]: r = −0.397 and ) and T-test scores (DL: r = −0.342; NDL: r = −0.321, ), respectively. The peroneal NCV was significantly positively correlated with dynamic balance (DL: r = 0.438 and ; NDL: r = 0.418 and ) and agility scores (DL: r = 0.639 and ; NDL: r = 0.641 and ) in athletes. In conclusion, significant associations were found between H-reflex and Peroneal nerve conduction velocity and key athletic performance parameters like dynamic balance and agility among university athletes. This implies that neural function is closely linked with athletic skills and performance. Registered in Clinical Trials Registry-India (CTRI) under registration number: REF/2023/11/075394.

Reliability and Validity of Hindi Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium: A Cohort Study.

The confusion assessment method for the intensive care unit (CAM-ICU) is a bedside tool to diagnose delirium in critically ill patients. This study aims to determine the reliability and validity of the Hindi version of CAM-ICU against the Diagnostic and Statistical Manual (DSM), fourth edition text revision (DSM-IV-TR), and DSM, fifth edition (DSM-5) criteria for diagnosis of delirium. Seventy-five Hindi-speaking consenting patients ≥18-year-old with Richmond Agitation Sedation Scale ≥-3 and an anticipated ICU stay > 48 hours were included. Patients with known severe mental illnesses, visual/hearing loss, neurological injury, burns, drug overdose, and Glasgow Coma Scale <9 at the time of screening were excluded. After 48 hours of ICU stay and ensuring at least 2 hours of sedative interruption, within a 4-hour period, two examiners independently assessed delirium using the Hindi version of the scale and an experienced psychiatrist assessed the patients independently and applied the DSM-IV-TR and DSM-5 criteria for diagnosing delirium. Time taken for CAM-ICU assessment, inter-observer reliability, sensitivity, specificity, and positive and negative predictive values were calculated. The Cohen's κ value was 0.944 (p < 0.001). The Cronbach's α for observer 1 and observer 2 was 0.961 and 0.968, respectively. The sensitivity and negative predictive value of the tool was 100% with both DSM-IV-TR and DSM-5. The specificity was 90.2% and 92% and the positive predictive value was 82.8 and 86.2% with DSM-IV-TR and DSM-5, respectively. The Hindi version of CAM-ICU is a reliable and valid tool for the diagnosis of delirium in an ICU setting. The study was registered with the Clinical Trials Registry, India (CTRI) as per the research guidelines laid down by the Indian Council of Medical Research before enrolling the participants. (CTRI number- CTRI/2021/01/030471). The registration date was 14th January 2021. URL of registry is http://ctri.nic.in. Delirium in the ICU is often undiagnosed due to unfamiliarity, lack of understanding of symptoms, non-availability of psychiatric consultation, and validated diagnostic tools in the native language of the patient. This study aims to find the reliability and validity of the Hindi version of CAM-ICU. Salhotra R, Bose A, Srivastava S, Mohta M, Pandarinathan K, Rautela RS. Reliability and Validity of Hindi Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium: A Cohort Study. Indian J Crit Care Med 2024;28(10):958-962.

Optimizing Stroke Care Transitions: A Patient-Centered Discharge Program for Caregivers

Inadequate discharge planning can worsen long-term outcomes for patients with stroke, delaying their recovery. Equipping caregivers with the knowledge to manage rehabilitation needs is crucial for facilitating a smooth hospital-to-home transition. The study aims to assess the effectiveness of a “Patient-Centered Discharge Program for Caregivers” on the comprehensiveness and clarity of discharge advice provided to caregivers of stroke survivors. Using a quasi-experimental design, the study compared a control group receiving standard discharge planning and an experimental group receiving the “Patient-Centered Discharge Program for Caregivers.” 62 caregivers of stroke survivors formed the participant pool. The program focused on various comprehensive discharge advice domains delivered to the caregivers. The discharge advice, knowledge, and skills of caregivers regarding stroke care were assessed on the day of discharge through questionnaires and checklists. Compared to the control group, the discharge instructions of the experimental group became more comprehensive and clear, with a significant improvement in knowledge and skills regarding stroke care ( p &lt; .05). The knowledge scores of the caregivers showed a statistically significant difference from the control group, with a mean difference of 8.78. ( p &lt; .05). The experimental group demonstrated good skills in nearly all procedures compared to the control group, including oral care, range of motion exercises, feeding, suctioning, and back care ( p &lt; .05). The “Patient-Centered Discharge Program for Caregivers” led to the delivery of more comprehensive discharge instructions, subsequently increasing caregivers’ knowledge. It highlights the benefits of such programs in equipping caregivers for effective discharge planning, with future research needed to evaluate long-term benefits. Trial/Protocol Registration: Clinical Trials Registry India (CTRI) CTRI/2023/07/055602 Link: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=89913&amp;EncHid=35558.64662&amp;modid=1&amp;compid=19

Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial.

Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% to 30% of the world's population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8. DERR1-10.2196/56063.

Effect of pelvic floor muscle exercise with postural advice on improving quality of life among pregnant mothers in bangladesh: a randomized controlled trial

BackgroundPelvic floor muscle exercise has gained recognition as a valuable adjunct for promoting maternal well-being and optimizing childbirth outcomes. This study aimed to evaluate the effectiveness of pelvic floor muscle exercise in enhancing the likelihood of improving quality of life pregnant mothers in Bangladesh.Methods/DesignThis was a randomized controlled trial in which 66 pregnant womenwere divided into control and intervention groups. The control group received conventional treatment, while the intervention group received the Pelvic Floor Muscles Exercise program with a posture explaining booklet. Both groups received supervised 30-min sessions five days a week for six weeks. The WHOQOL-BREF questionnaire measured pregnancy health and quality of life. Both descriptive (median and inter quartile range, IQR) and inferential statistics (Mann–whitney U test and Wilcoxon signed- ranked test) used to analyse the data by SPSS 25.0 software with 95% Confidence interval.ResultsThe intervention group mothers averaged gestional age was 32.4 (31.7 to 35.2) weeks, while the control group averaged 32.7 (32.3 to 36.2) weeks. According to the intergroup analysis, both groups had significantly improved health-related quality of life (p < 0.05). According to the intragroup analysis, participants who received pelvic floor muscle exercise with postural advice had better outcomes than did those who received only usual care with postural advice (p < 0.05).ConclusionPelvic floor muscle exercise may improve quality of life and the risk of vaginal birth. Healthcare professionals should include pelvic floor muscle exercises in standard prenatal care to help expectant mothers achieve positive childbirth and reduce postnatal problems.Trial registration: Clinical Trial Registry of India: (CTRI/2023/10/059091) (Date: 25/10/2023).

A study protocol for a randomized controlled trial on the effect of Surya Nadi Pranayama practice on cognitive abilities in school children

Abstract Background Surya Nadi Pranayama is a yogic breathing technique that involves controlled breathing through the right nostril. The study aims to evaluate the effects of the 20-min practice of Surya Nadi pranayama (4 weeks) on cognition among schoolchildren, comparing it to observing a normal breathing pattern. Methods A randomized control study design will be adopted for this study with 100 school children with 12–16 years of age, will be recruited. Subjects will be randomly divided into the study and control groups. The study group will be advised to practice Surya Nadi Pranayama (n = 50), whereas the control group (n = 50) will be asked to relax in a sitting posture between 9 am and 10 am, Monday to Friday, for 20 min daily over 30 days. Results A baseline and post-intervention assessment will be performed for all the subjects a day before and after the intervention. The primary outcome measures are visual reaction time and auditory reaction time. The secondary outcome is critical flicker fusion frequency. Conclusion The potential benefits of this yogic breathing technique and the findings of this research may contribute to the development of interventions aimed at improving cognitive functioning in school-aged children. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2024/05/067441).

Global postural re-education versus Egoscue exercises in upper cross syndrome on neck pain, forward head and rounded shoulder posture: a randomised clinical trial

Abstract Upper crossed syndrome (UCS) is a condition that is caused due to alternating tightness and weakness in the opposite muscle groups of the neck, shoulders, and upper back which results in abnormal postural deviations. Global postural re-education (GPR) and Egoscue exercises (EE) aim to improve postural alignment and reduce musculoskeletal discomfort by maintaining certain postures. There is a lack of literature where these approaches are not compared and hence the need arises to evaluate their efficacy in the management of UCS. A randomised clinical trial was conducted on 34 individuals with UCS, where 17 individuals were randomly allocated into two groups, i.e. Group A (GPR) and Group B (EE). Both groups received conventional therapy (hot moist pack and interferential current therapy) 3 times/week for 4 weeks. Outcome measures like craniovertebral angle (CVA), pectoralis minor index (PMI), tragus to wall test (TTW), deep cervical flexors endurance, neck disability index (NDI), and patient satisfaction were assessed at baseline and on day 12 post-treatment. Within group analysis has shown statistical significant improvement in all the outcomes (). Between group analysis has shown both interventions to be equally effective in CVA (), PMI (), TTW (), deep cervical flexors endurance (), NDI () and patient satisfaction scale (PSS) () in individuals with UCS. In conclusion, both the interventions were equally effective and can be included in the protocol for the better outcomes in musculoskeletal dysfunctions. This present trial was prospectively registered in the Clinical Trial Registry of India with registration number CTRI/2023/10/059361.

Evaluation of Comparative Efficacy of Levothyroxine Versus Kshar Basti and Kanchanar Guggul in the Treatment of Hypothyroidism: Protocol for a Randomized Controlled Trial.

The thyroid gland is an endocrine gland that has an impact on the body's general metabolism. Thus, the secretions of the thyroid gland can modify the overall metabolism of the entire body. The prevalence of hypothyroidism is increasing quickly, with rates of 2%-5% in affluent countries and 11% in India. Individuals diagnosed with hypothyroidism need to take medication for the rest of their lives, resulting in significant stress. Therefore, conducting a study in this area is imperative. This study aims to assess the effectiveness of the therapeutic enema (Kshar Basti) and oral Kanchanar Guggul in the treatment of hypothyroidism. The trial group (n=45) will receive a therapeutic enema (Kshar Basti) followed by oral Ayurvedic drugs for 180 days. The control group (n=45) will be given levothyroxine tablets at a dosage of 1.6 µg/kg/day for the same duration. The objective is to examine the alterations in thyroid stimulating hormone (TSH) levels before and after the treatment. Any deviation of the serum TSH by more than 20% from the initial values, while keeping triiodothyronine (T3), and thyroxine (T4) levels within the normal range, will be deemed statistically significant. Consequently, we anticipate a statistically significant variation in serum TSH levels between the therapeutic enema and Kanchanar Guggul treatments. Presently, the drug preparation operations are in progress. We expect to start enrolling patients in June 2024, do data analysis in December 2025, and acquire results by early 2026, marking the end of this trial. This study will evaluate the efficacy of the therapeutic enema, specifically Kshar Basti, in treating hypothyroidism. Furthermore, more research can determine the efficacy of a therapeutic enema (Kshar Basti) in treating overt hypothyroidism and hypothyroidism during pregnancy. Clinical Trials Registry India CTRI/2023/05/052389; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Nzk1NjY=&Enc=&userName=052389. PRR1-10.2196/57287.

Efficacy and safety of oral cyclophosphamide versus mycophenolate mofetil in childhood nephrotic syndrome: an open-label comparative study

IntroductionThere is a scarcity of research comparing the efficacy of cyclophosphamide and mycophenolate mofetil in childhood nephrotic syndrome. The aim was to evaluate the efficacy and safety of oral cyclophosphamide (CYC) and mycophenolate mofetil (MMF) in children with steroid-sensitive nephrotic syndrome in terms of the proportion of children who have been off steroids for at least 6 months without proteinuria (responders).MethodsThis open-label retrospective-prospective comparative study was conducted in a pediatric nephrology clinic of a referral center for children between 1 and 18 years of age with FR/SD nephrotic syndrome. Group A consisted of patients who received oral cyclophosphamide (100, 25% female) at a dose of 2–2.5 mg/kg once daily for a period of 8–12 weeks. Group B consisted of patients who received oral mycophenolate mofetil (n = 61, 18% female) (dose: 800–1200 mg/m2) for at least 12 months. Responders were defined as children who were off steroids for at least 6 months along with absence of proteinuria.ResultsIn the CYC group, 50% of the patients were responders, whereas 54% of the patients in the MMF group were responders (p = 0.614). The time to first relapse with CYC was 7 months (IQR 5.25–11) compared to 7 months (IQR 3.5–12) with MMF (p = 0.092). The relapse rate in the CYC group was 1.77 relapses per patient-year compared to 1.295 relapses per patient-year in the MMF group. The difference in relapse rate was significant (-0.474; 95% CI, 0.09 to 0.86 relapses/person-year) (p value = 0.009). Multivariate analysis revealed that an age of less than 5 years at the start of treatment was a significant factor for a better response to MMF (p value = 0.039, OR = 2.988, CI -1.055-8.468).ConclusionsThe efficacy of MMF was similar to that of CYC in terms of response (6 months without steroids) in children with FR/SD nephrotic syndrome. MMF showed a favorable response in terms of the frequency of relapse and treatment failure.Registration of the study with Clinical Trials Registry of India(http://ctri.nic.in;CTRI/2021/06/034421) (Dt: 28/06/2021).

True Digestibility of Tryptophan in Plant and Animal Protein

BackgroundProtein quality, evaluated using Digestible Indispensable Amino Acid Score (DIAAS), requires ileal digestibility values of individual indispensable amino acids (IAAs) in each protein. However, true tryptophan (Trp) digestibility has rarely been quantified in humans. ObjectiveTo measure the true Trp digestibility and DIAAS of 2H-intrinsically labeled plant and animal protein sources in humans, using the dual isotope tracer technique. MethodsThe true Trp digestibility of 2H intrinsically labeled plant proteins such as whole mung bean (n = 6) and dehulled mung bean (n = 6), chickpea (n = 5), and yellow pea (n = 5), and protein from animal source foods such as egg white (n = 6), whole egg (n = 6), chicken meat (n = 6), and goat milk (n = 7) was determined against the known digestibility of U-13C spirulina whole cell protein as reference, except for goat milk protein that was measured against free crystalline 13C-Trp as reference. Banked samples from earlier studies conducted to determine true IAA digestibility of different protein sources were used for the analysis. DIAAS was calculated for each test protein using digestibility corrected IAA scores (mg IAA/g of protein) in comparison with the IAA requirement score for adults. ResultsThe true Trp digestibility of whole mung bean, dehulled mung bean, chickpea, yellow pea, egg white, whole egg, chicken meat, and goat milk were 67.6 ± 3.7%, 74.5 ± 4.4%, 72.6 ± 2.3%, 72.5 ± 2.2%, 89.7 ± 2.5%, 91.4 ± 2.6%, 95.9 ± 2.2%, and 92.8 ± 2.9%, respectively. The true Trp digestibility of plant protein sources was significantly lower than that of animal protein sources (P < 0.05). Trp was not a limiting IAA in all the tested proteins. ConclusionThe true Trp digestibility determined in this study ranged from 67.6 ± 3.7% to 95.9 ± 2.2% for whole mung bean and chicken meat, respectively, and adds to the database of individual true IAA digestibility of different protein sources. Trial registration numberThis study was registered in Clinical Trials Registry of India (CTRI) with registration numbers CTRI/2017/11/010468, CTRI/2020/04/024512, and CTRI/2018/03/012265.

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Early detection of deteriorating patients in general wards through continuous contactless vital signs monitoring.

To assess the efficacy of continuous contactless vital signs monitoring with an automated Early Warning System (EWS) in detecting clinical deterioration among patients in general wards. A prospective observational cohort study was conducted in the medical unit of a tertiary care hospital in India, involving 706 patients over 84,448 monitoring hours. The study used a contactless ballistocardiography system (Dozee system) to continuously monitor heart rate, respiratory rate, and blood pressure. The study assessed total, mean, and median alerts at 24, 48, 72, 96, 120 h, and length of stay (LOS) before patient deterioration or discharge. It analyzed alert sensitivity and specificity, average time from initial alert to deterioration, and healthcare practitioners (HCP) activity. Study was registered with the Clinical Trials Registry-India CTRI/2022/10/046404. Out of 706 patients, 33 (5%) experienced clinical deterioration, while 673 (95%) did not. The deterioration group consistently had a higher number of alerts compared to those who were discharged normally, across all time-points. On average, the time between the initial alert and clinical deterioration was 16 h within the last 24 h preceding the event. The sensitivity of the Dozee-EWS varied between 67% and 94%. HCP spend 10% of their time on vital signs check and documentation. This study suggests that utilizing contactless continuous vital signs monitoring with Dozee-EWS in general ward holds promise for enhancing the early detection of clinical deterioration. Further research is essential to evaluate the effectiveness across a wider range of clinical settings.

Effectiveness and Safety of Varying Doses of Linezolid With Bedaquiline and Pretomanid in Treatment of Drug-Resistant Pulmonary Tuberculosis: Open-Label, Randomized Clinical Trial.

Treatment of drug-resistant tuberculosis with bedaquiline-pretomanid-linezolid regimen has demonstrated good treatment efficacy. Given linezolid's toxicity profile, prudence suggests reconsidering its dose and duration. We determined the effectiveness and safety of structured dose reduction of linezolid with bedaquiline and pretomanid in adults with pre-extensively drug-resistant (pre-XDR) or treatment-intolerant/nonresponsive multidrug-resistant (MDRTI/NR) pulmonary tuberculosis. Adults with pre-XDR or MDRTI/NR pulmonary tuberculosis were enrolled in a multicenter, parallel-group, randomized clinical trial in India. Patients were randomized to 26 weeks of bedaquiline, pretomanid, and daily linezolid, at 600 mg for 26 weeks (arm 1); 600 mg for 9 weeks followed by 300 mg for 17 weeks (arm 2); or 600 mg for 13 weeks followed by 300 mg for 13 weeks (arm 3). Study end points included sustained cure, bacteriological failure, toxicity, and death. Of 403 patients enrolled, 255 (63%) were <30 years old, 273 (68%) had prior tuberculosis episodes, and 238 (59%) were malnourished. At the end of treatment, after excluding those with negative baseline cultures, cure was seen in 120 (93%), 117 (94%), and 115 (93%) in arms 1, 2, and 3 respectively. Myelosuppression seen in 85 patients each in arms 1 and 2 and 77 patients in arm 3, not significantly different. Peripheral neuropathy was noticed in 66 patients (30, 17, and 19 in arms 1, 2, and 3) at 10-26 weeks (P = .02). The linezolid dose was reduced because of toxicity in 13, 2, and 4 patients in arms 1, 2, and 3, respectively. In adults with pre-XDR or MDRTI/NR pulmonary tuberculosis, structured linezolid dose reduction to 300 mg/d is as effective as the standard 600-mg dose but with fewer cases of peripheral neuropathy when given with bedaquiline and pretomanid. Clinical Trial Registry of India (CTRI/2021/03/032189).

A Randomized Controlled Trial Comparing the Effects of Vilazodone, Escitalopram, and Vortioxetine Monotherapy on the Metabolic Parameters in Patients With Major Depressive Disorder.

The coexistence of major depressive disorder (MDD) and metabolic illness could culminate in an aberrant metabolic profile. Individuals with MDD and type 2 diabetes mellitus (T2DM) are more likely to have impaired metabolic indicators. Effective antidepressant therapy can alleviate depressive symptoms and metabolic abnormalities. We focused on the effects of vilazodone, escitalopram, and vortioxetine on metabolic indices. Our research aimed to examine changes after 16 weeks of intervention in the glycemic indices, serum creatinine, lipid profile, hepatic parameters, and the Hamilton Depression Rating Scale (HDRS) 17-item version. A three-arm, randomized, open-label trial with 96 MDD patients was executed. Participants were divided into three distinct groups in a 1:1:1 ratio for 16 weeks and issued tablets of vilazodone (20-40 mg/day), escitalopram (10-20 mg/day), or vortioxetine (5-20 mg/day). Vilazodone and vortioxetine were the two test medications, while escitalopram served as the control. We stratified the participants as non-diabetics and diabetics. Follow-up appointments were slated four weeks after the initial visit. HDRS scores and other metabolic indicators were assessed at each visit in the per-protocol (PP) population. After 12 weeks, glycated hemoglobin (HbA1c) levels were measured. Lower HDRS scores indicated that depression-related symptoms had improved. We investigated the relationship between the 16-week differences in the fasting blood sugar(FBS) and HDRS scores. The Kruskal-Wallis test, Bonferroni correction, and Pearson correlation were all used in our analysis. We registered our trial prospectively in the Clinical Trial Registry of India (CTRI) (2022/07/043808). Of the 134 people we screened, 119 (81.34%) were deemed eligible. The PP population included 96 (88.07%) of those who completed the 16-week study. The population's average age was 46.3 ± 6.2 years. Across all study groups, the median baseline HDRS score was 30.0 (p = 0.964). At 16 weeks, the equivalent scores dropped to 15.0, 14.0, and 13.0 (p = 0.002). The median FBS levels at baseline and 16 weeks were 100.5, 104.0, and 98.0 (p = 0.491) and 91.5, 98.5, and 91.5 (p = 0.561), respectively. The post hoc analysis manifested no statistically significant changes between any parameters. Except for the reductions in glycemic indices in diabetic patients, no other data differed significantly. There was a positive relationship between FBS and HDRS scores. Irrespective of the diabetic situation, all three drugs substantially lowered HDRS scores. People with diabetes experienced noticeable declines in glycemic indices. Despite this, the patients' other metabolic indicators showed no significant alterations. We urge additional research with a larger sample size to investigate these medications' long-term impact on various metabolic indicators.