Clinical Trial Registry Of India Research Articles

Effect of Replacing Sucrose in Beverages with Nonnutritive Sweetener Sucralose on Cardiometabolic Risk Factors Among Asian Indian Adults with Type2 Diabetes: A 12-Week Randomized Controlled Trial.

Country-specific evidence-based research is crucial for understanding the role of nonnutritive sweeteners (NNS) in managing type2 diabetes (T2D). The main aim of this study was to explore the effect of replacing sucrose with sucralose in coffee/tea in Asian Indians with type2 diabetes (T2D). This 12-week, parallel-arm randomized controlled trial included 210 participants with T2D, assigned to the intervention group, where sugar/sucrose in coffee or tea was substituted with sucralose, or the control group, where sugar/sucrose was continued. Lifestyle factors remained unchanged. The primary outcome was change in HbA1c. Secondary outcomes were changes in body weight (BW), body mass index (BMI), waist circumference (WC), lipid profiles, and inflammatory markers. At the end of 12weeks, no change was observed in HbA1c, fasting plasma glucose, lipid profile, and inflammatory markers between or within groups. There was a small but significant reduction in BW (- 0.5kg [95%CI - 1.0, - 0.1]; p = 0.02), BMI (- 0.2kg/m2 [- 0.4, 0.0]; p = 0.03), and WC (- 0.8cm [- 1.4, - 0.3]; p = 0.002) in the intervention group. Improvements were also observed in lipid accumulation product (p = 0.01), visceral adiposity index (p = 0.04), triglyceride/glucose index (p = 0.04), total energy intake (p = 0.04), and carbohydrate intake (p < 0.0001). In Asian Indians with T2D, replacing about 60kcal of added sucrose with sucralose in coffee/ tea had no benefit on glycemia but resulted in a small reduction in body weight, body mass index, and waist circumference. Clinical Trials Registry of India (CTRI/2021/04/032686).

Correlates of disability among primary care patients with common mental disorders and chronic medical conditions- a cross-sectional study from rural South India.

We examined the correlates of disability among people with non-communicable diseases (NCDs) and comorbid common mental disorders (CMDs) from rural India. The sample comprised 2,486 participants enrolled in a cluster randomized trial (cRCT), Healthier OPtions through Empowerment (HOPE). Participants were 30 years or older, with a diagnosis of major depressive disorder, dysthymia, generalized anxiety disorder, and/or panic disorder on the MINI-International Neuropsychiatric Interview, with hypertension, diabetes, dsylipidemia and/ or ischemic heart disease. Disability was measured with the 12-item version of WHODAS 2.0. The severity of depression and anxiety was measured using the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Multiple linear regression analyses were used to examine associations. The mean age was 59 ± 10.0 years, three quarters (1864) of the participants were female, and 64.0% were married. More than half of the participants had no formal education (57.9%). Most of the participants had two or more chronic medical conditions (73.0%). The mean disability score was 24.3. The mean depression score was 8.5, and the mean anxiety score was 6.7. Higher levels of disability were reported by participants ≥ 60 years of age, those with moderate and severe depression, and moderate anxiety. Among female participants, being unmarried was associated with greater disability. Male participants without formal education reported greater levels of disability. Higher severity of CMDs is significantly associated with higher levels of disability. For women, being unmarried and for men having no formal education was associated with higher levels of disability. ClinicalTrials.gov NCT02310932 [URL: https://clinicaltrials.gov/ct2/show/record/NCT02310932 ] registered on December 8, 2014, and Clinical Trials Registry India CTRI/2018/04/013001, registered on April 4, 2018. Retrospectively registered.

Effectiveness of Pranic Healing as complementary therapy on lower urinary tract symptoms and sleep: Single-blind randomized trial

BackgroundBenign Prostatic Hyperplasia (BPH) commonly affects older men, leading to lower urinary tract symptoms (LUTS) that affect sleep and quality of life. This study evaluates the effect of Pranic Healing (PH) as a complementary therapy for bothersome LUTS by normalising biofield energy centres called Chakras. MethodologyA single blind trial involving 76 men with LUTS was conducted, randomised into Medication-only (MED) and Medication-plus-Pranic Healing (MEDPH) groups. The MEDPH received PH sessions twice weekly for 5 weeks. ResultsThe study compared MED (n = 30) and MEDPH (n = 36) participants, finding significant improvements in IPSS scores (p ≤ .001) in both groups. The MEDPH group showed a greater reduction in incomplete bladder emptying and intermittency. The post void residual volume increased significantly in the MED group (Wilcoxon Z = −2.335, p = .02), while the MEDPH group reduced non-significantly. Sleep quality index improved significantly (McNemar=.013) in the MEDPH group, while the MED group showed no significant change. Subjective sleep quality, duration, and latency improved significantly in the MEDPH group. Healers reported improved energy balance in chakras of MEDPH group. Perceived energy by healers in lower chakra relates to urinary parameters. ConclusionPH could alleviate LUTS, enhancing quality of life due to urination, and improved sleep, among moderate BPH patients. Trial registrationThis study has been registered under the Clinical Trial Registry of India. (CTRI No: CTRI/2023/01/049004)

The effect of high-definition transcranial direct current stimulation on pain in somatic symptom disorder with predominant pain: A randomized single-blind sham-controlled crossover study

Somatic symptom disorder with predominant pain (SSD-P) is a commonly encountered disorder, yet treatment options often yield unsatisfactory outcomes. Transcranial direct current stimulation (tDCS) has proven useful in chronic pain conditions and may hold potential for treating somatoform pain. High-definition tDCS (HD-tDCS) offers more precise cortical stimulation than conventional tDCS. However, this modality has not been extensively studied in SSD-P. Consequently, this study aims to assess the effects of a novel HD-tDCS protocol on pain and other associated variables in patients with SSD-P. The Institute Ethics Committee approved the study, which was also registered in the Clinical Trials Registry of India. A single-blind, sham-controlled, crossover study design was employed. Thirty right-handed patients with DSM-5 diagnosis of SSD-P, aged 18 &amp;ndash; 60 years and receiving stable treatment, were enrolled through consecutive sampling. After simple randomization, two repeated, short-interval sessions (2 mA, 20 min each) of either active or sham HD-tDCS were administered, followed by a washout period of 7 days and a subsequent crossover. Assessments were conducted at baseline, week 1, and week 2. Participants in active and sham arms were comparable on all baseline parameters. At the end of the 1st week, patients in the active group showed significant improvement in the study variables compared to the sham group. By week 2, all participants, irrespective of being in the active or sham arm, demonstrated a statistically significant difference (Cohen&amp;rsquo;s d &gt; 0.8) in pain and associated parameters such as depression, anxiety, pain-related interference, burden, and disability (P &lt; 0.01). Transient mild local side effects such as burning, pain, and itching were noted, with no cognitive side effects reported. In conclusion, this novel HD-tDCS protocol is effective in reducing pain in patients with SSD-P, with sustained effects up to 1 week.

A Randomized Controlled Trial of the Safety and Efficacy of Systemic Enzyme Supplementation on Symptoms and Quality of Life in Patients with Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis (IPF) imposes a substantial symptom burden that adversely impacts patients' quality of life. Current anti-fibrotic treatments for IPF provide limited symptomatic relief, necessitating the implementation of complementary disease management strategies to enhance health-related quality of life (HRQOL). Serracor-NK® and Serra Rx260, systemic enzyme supplements, improved symptoms and HRQOL with favorable safety profiles in a proof-of-concept study in PF patients. This prospective, double-blind randomized placebo-controlled trial enrolled 100 IPF patients from six institutions. The supplement group (n = 50) received the oral systemic enzyme supplements Serracor-NK® and Serra Rx260 in addition to standard care for 6 months, while the placebo group (n = 50) received standard care alone. The primary objective was to evaluate the regimen's impact on symptoms, QOL, and well-being using the UCSD shortness of breath (UCSD-SOB) questionnaire, St. George's respiratory questionnaire (SGRQ), and WHO well-being index (WHO-5). Safety evaluation was a secondary objective. A significantly higher proportion of patients in the supplement group demonstrated meaningful improvement in symptoms as compared to the placebo group, as assessed by the UCSD-SOB (p < 0.05) and SGRQ questionnaires (p < 0.05). Additionally, a significantly greater proportion of patients in the supplement group showed improved QOL and well-being (p < 0.05) and reduced health impairment (p < 0.05), as assessed by SGRQ. Mental well-being (WHO-5) and physical activity (SGRQ activity domain) did not differ significantly between the groups. Safety assessments, including liver function tests and vital signs, indicated that the supplement regimen was well tolerated. To conclude, Serracor-NK® and Serra Rx260 alleviate symptoms and enhance HRQOL in IPF patients with a favorable safety profile (Clinical Trials Registry India registration number: CTRI/2020/05/025374).

Combined corneal biomechanical and tomographical indices in subclinical and forme fruste keratoconus.

Evaluation of combined corneal tomographic and biomechanical parameters in subclinical/forme fruste keratoconus (ScKC/FFKC). Cross-sectional observational case-control study. Thirty-one eyes with ScKC (fellow eye of KC with any one sign: keratometry >47 diopters, cylinder >1.5 D, central corneal thickness <500 µm, with/without abnormal topography) or FFKC (fellow eye of KC with normal topography and slit lamp examination) >13 years (cases) and 44 eyes of age-matched 22 healthy subjects (controls). Clinically diagnosed KC, presence of corneal scars, and prior ocular surgery eyes. Sixteen Pentacam, 15 Corvis ST, and five Sirius parameters were analyzed using paired sample t -test, and a subsample found to be significantly different was used in receiver operating characteristic curve analysis. The Youden index was calculated, and Pearson's correlation analysis was done. Five Pentacam, three Corvis ST, and two Sirius parameters had an area under curve (AUC) >0.75. Tomographic and biomechanical index (TBI) (cutoff 0.59, 95% specificity, 77% sensitivity), Belin Ambrosio enhanced ecstasia display (cutoff 1.8, 81% specificity, 80% sensitivity), and symmetry index of posterior corneal curvature (cutoff 0.16, 97% specificity, 67% sensitivity) best identified early KC. TBI strongly correlated with maximum Pentacam parameters in both cases and controls. Corvis biomechanical index strongly correlated only in cases, and SP-A1-SD weakly correlated in cases. Upon combined analysis, the average sensitivity and specificity, respectively, of top three parameters (according to AUC) from Pentacam and Corvis ST were 74.1% and 95.4% for posterior elevation and TBI. The trial was registered in Clinical Trial Registry of India on January 28, 2022. The Trial Registration Number is REF/2022/01/050638.

Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial

Abstract Objective: The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin. Methodology: This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin &gt;7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks. Results: Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets. Conclusion: Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end. This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342.

Efficacy and safety of quick penetrating solution heparin, quick penetrating solution diclofenac, and heparin gel in the prevention of infusion-associated superficial thrombophlebitis: A randomized controlled trial

Abstract Background: The present study aimed to compare the efficacy, safety, and cost-effectiveness of quick penetrating solution (QPS) heparin, QPS diclofenac, and heparin gel in the prevention of superficial thrombophlebitis (ST). Materials and Methods: This randomized controlled trial was conducted after approval from the Institutional Ethics Committee and registration to Clinical Trial Registry of India. Patients of 18–60 years age, American Society of Anesthesiologists I/II, and who needed venous cannulation for at least 72 h were included in the study. Patients were randomly divided into three groups receiving study drugs (heparin gel, QPS heparin, and QPS diclofenac) every 8 hourly for a period of 72 h. Venous cannulation site was graded using the Visual Infusion Phlebitis Scale. Patients developing no ST, mean time to reach ST Grade 1 and 2, prevention of ST probability, and cost-effectiveness of interventions during the study period were assessed. Results: Out of 219 included patients, development of no ST in the study groups at 72 h of treatment were heparin gel (11%), QPS heparin (9.6%), and QPS diclofenac (2.7%). The mean time (hours) to develop any grade ST in the study arms was heparin gel (36.2 [11.9]), QPS heparin (40.0 [13.4]), and QPS diclofenac (37.0 [13.2]). The Kaplan–Meier analysis did not reveal significant differences for the prevention of any grade ST or severe ST in three treatment arms. The average cost-effectiveness ratio for preventing thrombophlebitis was 14.2 in heparin gel-, 13.2 in QPS heparin-, and 95.6 in QPS diclofenac-treated patients. Conclusion: Based on efficacy, safety, and cost-effectiveness, heparin gel or QPS heparin can be used to prevent ST due to intravenous cannulation in surgical patients. QPS diclofenac is not a cost-effective option to prevent ST.

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial

BackgroundCleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment.MethodThe NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site.DiscussionWe expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe.Trial registrationClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up.How to search: (https://ctri.nic.in/Clinicaltrials/advsearch.php—use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial

Study design This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design. Objective To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin. Setting The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital. Methods Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests. Results Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline. Conclusion Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry. Trial registration: Clinical Trials Registry India identifier: CTRI/2018/05/013735.

O-202 Novel use of hyaluronan enriched media for improving implantation in intrauterine insemination: a prospective randomised controlled trial (HEMI Trial)

Abstract Study question Does the intrauterine instillation of hyaluronan-enriched media influence the implantation rate and reproductive outcomes in patients undergoing controlled ovarian stimulation and intrauterine insemination? Summary answer The intrauterine instillation of Hyaluronan-enriched media significantly improved the implantation rates and ongoing pregnancy rate in women undergoing controlled ovarian stimulation and intrauterine insemination treatment What is known already Hyaluronan is a macromolecule belonging to the glycosaminoglycans family, secreted by cumulus granulosa cells, and is naturally present in the female reproductive tract. Various mechanisms have been proposed to explain the implantation-enhancing properties of Hyaluronan including increased cell-cell and cell-matrix adhesion, by producing a viscous environment for the integration of embryo in intrauterine fluid and its autocrine and paracrine functions via CD44 receptors. This is probably the first trial studying the effect of hyaluronan-enriched media in intrauterine insemination treatment. The proposed novel intervention is based on the biological plausibility and proven safety of hyaluronan in IVF studies. Study design, size, duration This parallel group Randomised Controlled trial was conducted over 2 years of duration, from 2021 to 2023. A total of 100 couples diagnosed with unexplained infertility planned for controlled ovarian stimulation and intrauterine insemination (COS-IUI) treatment were randomized into the intervention and control arm of the trial. Before the commencement of the study, the trial was registered with the Clinical Trial Registry-India (CTRI), and institutional ethical approval was obtained. Participants/materials, setting, methods 100 couples diagnosed with unexplained infertility attending tertiary-level university hospital were allocated to the intervention and control group using block randomization in 1:1 allocation. In the intervention group, the participants underwent intrauterine instillation of 0.4 ml of hyaluronan enriched media, 4 days following intrauterine insemination treatment. The statistical package SPSS (version 21) was used for analysis and results were considered to be statistically significant if the P-value was &amp;lt;0.05. Main results and the role of chance The mean female age of the study population was 28.12±3.74 years with an average duration of infertility of 3.95 ±2.17 years. The study participants underwent an average of 1.7 IUI cycles in the control group and 1.6 cycles in the intervention group. A cumulative biochemical pregnancy rate of 36.5% and 16.6% was observed amid the the intervention group and control group respectively and the difference was statistically significant with a p-value of 0.039. Similarly, the cumulative ongoing pregnancy rate beyond 20 weeks of gestation was statistically significantly higher among the intervention arm of the trial as compared to the control group (31.7% vs 11.9%, p = 0.035). There was a trend of improved clinical pregnancy rate among the intervention participants, however, this difference did not reach statistical significance (34.1% vs 16.6%, p = 0.067). The miscarriage rate was comparable among both groups. The number needed to treat was estimated to be 5, which in effect meant that 5 women would have to receive intrauterine instillation of hyaluronan enriched media for 1 additional ongoing pregnancy. Limitations, reasons for caution The longer follow-up period would have allowed the reporting of live-birth rate which is undeniably the most meaningful parameter to appraise an intervention. Larger multicentric studies are required to establish the clinical benefit and generalisability of the proposed intervention. Wider implications of the findings The study proposes a potential novel, simple, minimally invasive, and patient-acceptable intervention to increase the success rates of intrauterine insemination. Being the first study on the topic, the study can provide a basis for future large multicentric studies on the topic. Trial registration number Clinical Trial Registry-India (CTRI) number- CTRI/2021/10/037064.

Impact of Concurrent Exercise Training on Cardiac Autonomic Modulation, Metabolic Profile, Body Composition, Cardiorespiratory Fitness, and Quality of Life in Type 2 Diabetes with Cardiac Autonomic Neuropathy: A Randomized Controlled Trial.

Background: Type 2 diabetes mellitus (T2DM) often leads to cardiac autonomic neuropathy (CAN), a severe complication affecting cardiovascular health. Exercise training is a proven intervention for improving metabolic control and cardiovascular health in T2DM, but the effects of concurrent exercise training (CET), combining aerobic and resistance exercises, on CAN are not fully understood. Objective: This randomized controlled trial investigates the impact of a structured CET program on cardiac autonomic modulation, metabolic profile, body composition, cardiorespiratory fitness (CRF), and quality of life (QoL) in individuals with T2DM and CAN. Methods: A total of 96 participants, aged 35-70 years, with T2DM and CAN, were randomized into CET (n = 48) and control (n = 48) groups. The CET group engaged in combined aerobic and resistance training three times per week for 13 weeks, while the control group received standard care. Primary outcomes included heart rate variability (HRV) and heart rate recovery (HRR). Secondary outcomes were metabolic profile, body composition, CRF, and QoL, which were assessed using standardized protocols and validated questionnaires. The trial was registered with the Clinical Trials Registry-India (CTRI/2021/09/036711). Results: Significant improvements were noted in the CET group compared to controls. HRV metrics (SDNN, RMSSD, pNN50, TP, LF power, HF power, and LF/HF ratio) and HRR metrics (HRR30s, HRR1, HRR2, and HRR3) all showed significant enhancements (p < 0.01). The CET group also exhibited substantial reductions in fasting blood glucose, postprandial blood glucose, HbA1c, waist circumference, hip circumference, and percentage body fat (p < 0.01). Improvements were observed in lipid profile markers and CRF (VO2max) (p < 0.01). QoL scores improved significantly in the CET group as per the ADDQoL-19 (p < 0.01). Conclusions: CET significantly enhances cardiac autonomic modulation, metabolic profile, body composition, CRF, and QoL in individuals with T2DM and CAN. These findings support the integration of CET into standard T2DM management to improve clinical outcomes and QoL. Further research is needed to explore the long-term benefits and broader applicability of CET in diverse diabetic populations.

Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA)

BackgroundCardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication.MethodsThe intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4–5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done.DiscussionThe effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment.Trial registrationThe trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

Nurses’ Emotional Labor and Intrinsic Motivation: Findings from a Cross-sectional Study

Abstract Aim: This cross-sectional study aimed to determine the level of nurses’ emotional labor and intrinsic motivation (IM) and to assess its relationship with patients’ perceptions of nursing care. Methodology: Data were provided by 71 staff nurses and corresponding 71 patients from a tertiary care hospital. The Emotional Labor (EL) Scale by Brotheridge and Lee, a self-structured IM Scale, and the Perception of Nursing Care Scale were used to collect the data between January and March 2021. The study is registered in the Clinical Trial Registry of India (CTRI/2019/08/020592). Results: The study reveals that nurses frequently use EL in their work, use deep-acting more than surface-acting EL, and have a high level of IM. The patients were found to have a good perception of nursing care, with “good communication” as the highest-rated factor. No significant correlation was found between nurses’ EL and IM with patients’ perceptions of nursing care. Conclusion: As nurses frequently use emotional labor at work, it may lead to emotional dissonance. Therefore, interventions on emotional regulation skills may allow them to skillfully use emotional labor in practice and enable them to cope with the increased emotional demands at work.

Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.

We evaluated whether the addition of docetaxel (D) to a combination comprising 5-fluorouracil/leucovorin (5-FU/LV) or capecitabine (C) plus oxaliplatin (O) (DOF/DOX) improved overall survival (OS) compared with 6 months of5-fluorouracil (5-FU) or capecitabine in combination with oxaliplatin (FOLFOX/CAPOX) alone in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas (G/GEJ). This study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced G/GEJs. The primary endpoint of the study was a comparison of median OS by Kaplan-Meier method. Next-generation sequencing was performed on tissue. Of the 324 patients randomly assigned between July 2020 and November 2022, 305 patients were evaluable for analysis (FOLFOX/CAPOX: 156; DOF/DOX: 149). With a median follow-up time of 19.2 months(95% Confidence Interval [CI] = 16.5 months to 21.9 months) for the entire cohort, the median OS was 10.1 months (95% CI = 9.2 to 10.9) for FOLFOX/CAPOX and 8.9 months (95% CI = 7.3 to 10.5) for DOF/DOX, and this difference was not statistically significant (P = .70). An increased proportion ofgrade 3 or grade 4 neutropenia (21% vs 3%; P < .001) and grade 2/3 neuropathy (17% vs 7%; P = .005) was seen in patients receiving DOF/DOX. Genomic profiling revealed a low incidence of microsatellite instability (1%) and a high incidence of BRCA1 (8.4%) and BRCA2 (7.5%) somatic alterations. FOLFOX or CAPOX chemotherapy for 6 months remains one of the standards of care in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas, with no additional survival benefit seen with the addition of docetaxel. Genomic profiling of patients revealed a higher than previously known incidence of somatic BRCA alterations, which requires further evaluation.CTRI (Clinical Trial Registry of India: CTRI/2020/03/023944).

Do Indian men have similar oncological outcomes with abiraterone plus androgen deprivation therapy in the setting of metastatic hormone-sensitive prostate cancer? A prospective observational study.

Combination of abiraterone with androgen deprivation therapy (ADT) has better survival outcomes than ADT alone in metastatic Hormone-sensitive prostate cancer (mHSPC) in the Western population. In this prospective (Clinical Trials Registry-India [CTRI] registered) observational study, we present the comparative oncological outcomes of ADT alone and ADT + abiraterone in Indian patients, which is not available currently. This study (CTRI-number-CTRI/2020/07/026545) included newly diagnosed mHSPC patients from January 2020 to June 2023 in a tertiary care hospital, urology department. Patients fulfilling inclusion criteria were advised ADT with abiraterone (A + ADT), and those not affording received ADT monotherapy (ADT). The primary endpoint was overall survival (OS). Secondary outcomes included prostate-specific antigen (PSA) decline >90%, radiographic progression-free survival (rPFS), and PSA progression-free survival (pPFS). Out of 278 patients with mHSPC, 163 patients were excluded and 115 were analyzed (ADT = 40 vs. A + ADT = 75). After a median follow-up of 20.3 months, 11 of 40 (27.5%) in ADT-only arm and 15 of 75 (20%) in ADT + abiraterone arm had died (Hazard-ratio of death 0.72; 95% confidence interval 0.68-0.88; P < 0.001). A PSA decline of >90% was seen in 85% in the ADT alone group and 93.3% in the ADT + abiraterone group. Significantly better outcomes of the ADT + abiraterone were seen in the secondary endpoints of rPFS (P < 0.001) and pPFS (P < 0.001). The OS benefit was 28% reduction in risk of death in our study versus 37% and 38% in STAMPEDE and LATITUDE, respectively. pPFS and rPFS were also poorer in Indian subsets. Abiraterone with ADT improves OS, PSA response, rPFS, and pPFS in the Indian population akin to the Western data but with poorer OS, rPFS, and PSA progression-free survival on comparison.

Calcitriol in Sepsis-A Single-Centre Randomised Control Trial.

Background/Objectives: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is a significant cause of hospital admission and the leading reason for admission to the ICU and is associated with high mortality. Vitamin D has shown promising immunomodulatory effects by upregulating the antimicrobial peptide, cathelicidin. However, previous studies analysing the use of calcitriol in sepsis have shown variable results and did not utilise APACHE II (Acute Physiology and Chronic Health Evaluation II) scores as endpoints. This study evaluates the efficacy of intramuscular calcitriol in patients admitted to the ICU with sepsis, focusing on its impact on APACHE II scores. The primary aim was to determine if intramuscular calcitriol improved APACHE II scores from day 1 to day 7 or discharge from the ICU, whichever was earlier. Secondary outcomes included 28-day mortality, ventilator days, vasopressor days, ICU stay length, adverse events, and hospital-acquired infections in ICU patients. Methods: This was a triple-blinded phase III randomised control trial. A total of 152 patients with suspected sepsis were block-randomised to receive either intramuscular calcitriol (300,000 IU) (n = 76) or a placebo (n = 76). The trial was registered with the Clinical Trials Registry-India (CTRI No: CTRI 2019/01/17066) following ethics committee approval and was not funded. Results: There was no significant difference in APACHE II scores between the calcitriol and placebo groups from day 1 to day 7 (p = 0.382). There were no significant changes in 28-day mortality (14.4% vs. 17%, p = 0.65), number of days on a ventilator (5 vs. 5, p = 0.84), number of days on vasopressors (3 vs. 3, p = 0.98), length of ICU stay (10 days vs. 11 days, p = 0.78), adverse events (27.6% vs. 19.7%, p = 0.25), and hospital-acquired infections (17.1% vs. 15.8%, p = 0.82). Conclusions: There was no effect of intramuscular calcitriol in patients admitted to the ICU with sepsis.

Effectiveness of craniosacral therapy, Bowen therapy, static touch and standard exercise program on sleep quality in fibromyalgia syndrome: A randomized controlled trial

BackgroundSleep disturbance is commonly seen in fibromyalgia syndrome (FMS); however, high quality studies involving manual therapies that target FMS-linked poor sleep quality are lacking for the Indian population. ObjectiveCraniosacral therapy (CST), Bowen therapy and exercises have been found to influence the autonomic nervous system, which plays a crucial role in sleep physiology. Given the paucity of evidence concerning these effects in individuals with FMS, our study tests the effectiveness of CST, Bowen therapy and a standard exercise program against static touch (the manual placebo group) on sleep quality in FMS. Design, setting, participants and interventionA placebo-controlled randomized trial was conducted on 132 FMS participants with poor sleep at a hospital in Bangalore. The participants were randomly allocated to one of the four study groups, including CST, Bowen therapy, standard exercise program, and a manual placebo control group that received static touch. CST, Bowen therapy and static touch treatments were administered in once-weekly 45-minute sessions for 12 weeks; the standard exercise group received weekly supervised exercises for 6 weeks with home exercises until 12 weeks. After 12 weeks, all study participants performed the standard exercises at home for another 12 weeks. Main outcome measuresSleep quality, pressure pain threshold (PPT), quality of life and fibromyalgia impact, physical function, fatigue, pain catastrophizing, kinesiophobia, and positive–negative affect were recorded at baseline, and at weeks 12 and 24 of the intervention. ResultsAt the end of 12 weeks, the sleep quality improved significantly in the CST group (P = 0.037) and Bowen therapy group (P = 0.023), and the PPT improved significantly in the Bowen therapy group (P = 0.002) and the standard exercise group (P < 0.001), compared to the static touch group. These improvements were maintained at 24 weeks. No between-group differences were observed for other secondary outcomes. ConclusionCST and Bowen therapy improved sleep quality, and Bowen therapy and standard exercises improved pain threshold in the short term. These improvements were retained within the groups in the long term by adding exercises. CST and Bowen therapy are treatment options to improve sleep and reduce pain in FMS. Trial registration numberRegistered at Clinical Trials Registry of India with the number of CTRI/2020/04/024551.Please cite this article as: Ughreja RA, Venkatesan P, Gopalakrishna DB, Singh YP, Lakshmi VR. Effectiveness of craniosacral therapy, Bowen therapy, static touch and standard exercise program on sleep quality in fibromyalgia syndrome: a randomized controlled trial. J Integr Med. 2024; 22(4): 474–484.

Role of low-pressure negative pleural suction in patients with thoracic trauma - a randomized controlled trial.

Thoracic trauma frequently includes a pneumothorax, hemothorax, or hemopneumothorax, which may necessitate an Intercostal drainage (ICD) for air and fluid evacuation to improve breathing and circulatory function. It is a simple and life-saving procedure; nevertheless, it carries morbidity, even after its removal. Efforts have been made continuously to shorten the duration of ICD, but mostly in non-trauma patients. In this study, we evaluated the impact of negative pleural suction over the duration of ICD. This study was a prospective randomized controlled interventional trial conducted at Level 1 Trauma Centre. Thoracic trauma patients with ICD, who met the inclusion criteria (sample size 70) were randomized into two groups, the first group with negative pleural suction up to -20 cm H2O, and the second group as conventional, i.e. ICD connected to underwater seal container only. The primary objective was to compare the duration of ICDs and the secondary objectives were the length of hospital stay and various complications of thoracic trauma. Duration of ICD was measured in median days with minimum & maximum days. For the negative suction group, it was 4 days (2-16 days); for the conventional group, it was also 4 days (2-17 days). There was also no significant difference among both groups in length of hospital stay. The beneficial effect of negative pleural suction to ICD could not be demonstrated over the duration of ICD and hospital stay. In both groups, there was no significant difference in complication rates like recurrent pneumothorax, retained hemothorax, persistent air leak, and empyema. Therapeutic Study, Level II TRIAL REGISTRATION: This trial was registered with the Clinical Trial Registry of India (CTRI) with registration no. REF/2020/11/038403.

Comparative evaluation of intubator performance and time taken for intubation in COVID patients using two different barrier devices requiring emergency endotracheal intubation: A randomized cross over study

BackgroundThe COVID-19 pandemic has necessitated use of barrier devices, such as goggles and face shields, during endotracheal intubation procedures to protect healthcare professionals. While there is existing research on the efficacy of these devices in simulated environments, there is a lack of published studies comparing their utility in real COVID-19 cases. This randomized crossover study aimed to compare the performance of face shields and goggles during endotracheal intubation in actual COVID-19 cases. MethodsThe study was registered in Clinical Trials Registry of India with registration no. CTRI/2022/07/044114 and was conducted at a tertiary care hospital emergency Operartion theatres (OTs) from May 2022 till March 2023. Experienced airway management professionals participated in the study, with a sample size of 128 participants: using either face shields (Group F) or goggles (Group G). The participants performed intubation attempts using both face shields and goggles in a crossover manner. Subgroups were formed based on whether participants wore medically prescribed spectacles or not. The numerical variables were analyzed by Mann-Whitney U test/Unpaired t-test. The categorical variables were analyzed by Chi-square test/Fischer exact-test. ResultsThe overall intubation time was significantly shorter in face shield group (12.75 ± 1.84 s) compared to the goggles group (14.30 ± 1.96 s) (P < 0.005). Additionally, the time taken for endotracheal tube insertion into the glottis was significantly shorter in the face shield group (3.52 ± 1.22 s) compared to the goggles group (4.26 ± 1.37 s) (P < 0.005). Participants rated the vision and clarity higher in the face shield group (P < 0.001). However, they found face shields to be more claustrophobic compared to goggles (P < 0.001). ConclusionThe study concludes that face shields may offer benefits in terms of faster intubation times, improved vision and clarity, better ergonomics and also more suited for healthcare workers with prescribed spectacles, but potential claustrophobic effects to be kept in mind while selecting protective equipment for healthcare professionals performing intubations.