Clinical Trial Registry Of India Research Articles

Efficacy of Kushmanda Benincasa hispida (thunb.) Cogn. and Yastimadhu (Glycyrrhiza glabra Linn.) on Medha (intellectual capacity) in Malnourished School-Going Children: A Study Protocol of an Open-Label Randomized Controlled Clinical Trial

Abstract BACKGROUND: Malnutrition adversely affects the intelligence quotient (IQ), with a more pronounced impact on short-term memory, visual perception, and visual-motor integration compared to verbal reasoning and understanding. The negative effects of malnutrition can be avoided by correcting mild to moderate undernutrition. Consequently, Kushmanda Benincasa hispida (Thunb.) Cogn. and Yastimadhu (Glycyrrhiza glabra Linn.) are chosen for the current study because they share similar properties as Medhya (nootropic), Balya (nutritive), Vrishya (aphrodisiac), Hridhya (cardiotonic), and Rasayana (rejuvenation). OBJECTIVE: To assess the efficacy of Kushmanda and Yastimadhu granules on IQ in malnourished children of school-going age. MATERIALS AND METHODS: The study is designed as a single-center, randomized, active-controlled, open-label clinical trial in which 240 IAP Grade 1 and Grade 2 undernutrition students between 11 and 12 years will be chosen from nearby primary schools for participation. Weschler’s Intelligence Scale (also known as Malin’s Intelligence Scale for Indian Children) will be used to measure IQ, and those with scores between 70 and 89 will be randomly divided into two groups of 120 participants each, with one group receiving Kushmanda granules and the other receiving Yastimadhu granules at a predetermined dosage may be added for a month. DISCUSSION AND CONCLUSION: It is anticipated that this will lead to an increase in IQ and weight gain in malnourished youngsters. A variety of factors influence IQ, and one of those is nutrition. This study will investigate the effect of nootropic and nutritional actions of Kushmanda and Yastimadhu granules on undernourished school-age children with borderline intelligence. TRIAL REGISTRATION: The trial has been registered at the Clinical Trials Registry-India (CTRI); the registration number for this trial is CTRI/2023/02/049381, on the date 01/02/2023.

Improving adolescents’ dietary behavior through teacher-delivered cancer prevention education: a school-based cluster randomized intervention trial in urban Rajasthan

BackgroundDietary practices are one of the most common modifiable risk factors for cancers. Foods rich in dietary fibers are considered protective, meanwhile fast & junk foods are risk for common cancers. Adolescence period is marked by habit formation and is thus suited for delivering behavioral intervention. Schools offer an optimal setting for planning and executing these interventions to a large number of adolescents.ObjectiveTo assess the effectiveness of a teacher-delivered cancer-prevention education in changing dietary behaviors of school going adolescents.MethodsA cluster randomized trial was conducted in government secondary and senior secondary schools with schools as clusters. A minimum required sample of 1032 students was estimated from 16 schools with 1:1 allocation in intervention and non-intervention groups. Dietary behaviors were recorded as dichotomous variable. The determinants were recorded as per theory of planned behavior framework using Likert-scale. Two teachers from each intervention school were trained to deliver cancer prevention education with focus on role of dietary behavior. Pre-post training assessment of teachers’ knowledge towards common cancers was done using a self-administered questionnaire. Gender adjusted difference-in-difference analysis was done to assess intervention effect on both healthy and unhealthy behaviors.ResultsIn selected schools all students from classes 8 to 10 were approached and a total of 1224 students were enrolled, of whom 1096 completed the study. The study recorded significant improvement in scores of students from intervention group compared to non-intervention group for their attitude, subjective norms, perceived behavioral control and intention towards consuming healthy and avoiding unhealthy foods. The intervention was effective in significantly improving the proportion of students limiting fried/fast/packed food & sugar sweetened beverages (OR:1.51, 95%CI:1.08,2.12,p:0.017), and consuming fruits & vegetables daily (OR:1.55, 95%CI:1.08,2.22, p:0.017) while adjusting effect of gender.ConclusionClassroom-based cancer prevention education delivered through teachers during regular working hours is effective in improving dietary behaviors and its determinants among adolescent students. Thus, we recommend integrating a section focusing on the role of diet in cancer prevention and other lifestyle diseases in the existing school curriculum.Trial RegistrationThe trial was registered under Clinical Trial Registry-India with registration number CTRI/2018/12/016586, dated-10/12/2018.

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial

BackgroundCornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count.Methods and designTIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications.ConclusionIn this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year.SAP Version 0.1 (dated: 28 April 2023)Protocol version:2.0Trial registrationClinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464

On-Arrival Lumbar Epidural Analgesia for Lower Limb Trauma Pain in Emergency Care: A Superiority Randomized Controlled Trial.

Lower limb trauma in emergency settings often leads to pain management challenges. Traditional methods, primarily non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, have limitations. This study explores the efficacy of epidural analgesia in emergency for lower limb trauma patients (ELETRA) as an alternative for managing pain in lower limb trauma patients upon arrival in emergency care. This study primarily focuses on determining ELETRA's effectiveness in reducing pain for patients with lower limb trauma upon arrival. It also aims to evaluate ELETRA's influence on decreasing stress and shortening hospital stays compared to traditional pain management approaches. This study was executed as a prospective, parallel-design, randomized controlled trial in the emergency department of a tertiary care teaching hospital. The interventions were performed in a dedicated induction room adjacent to the emergency operating theater. The trial was registered in the Clinical Trial Registry of India with registration number CTRI/2022/08/044699 dated 16/08/2022.Participants were 18- to 50-year-old patients with lower limb injuries, classified under American Society of Anesthesiologists (ASA) class 1 or 2. Participants were randomized into two groups: one receiving ELETRA and the other standard pain control treatment. The effectiveness of pain relief was measured through a visual analogscale (VAS), and hemodynamic parameters, adverse effects, levels of acute phase reactants, and stress hormones were also measured along with patient satisfaction. The study enrolled 356 participants with lower limb injuries. After excluding participants lost following the intervention, data from 157 individuals in Group A and 160 in Group B were analyzed. Group A's success rate for analgesia (VAS < 2) was 92.35% (n = 145), significantly higher than Group B's 75.62% (n = 121) (p < 0.001). The commonest side effect was hypotension (5.73%) inGroup Aand nauseainGroup B (7.5%). C-reactive protein (CRP) levels rose to 104.71 ± 8.99 mg/dL in Group A and 192.58 ± 9.23 mg/dL in Group B; the difference was statistically significant. Serum cortisol levels were also higher in Group B (67.18 ± 9.21) compared to Group A (44.72 ± 6.14) at one week. Group B had a longer hospital stay, averaging 12.24 ± 4.81 days, against Group A's 10.19 ± 4.91 days. ELETRA is a safe and effective alternative for pain management in lower limb trauma patients in emergency settings. It reduces pain, improves patient satisfaction, and has a favorable impact on stress responses.

Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match.

In India, regulatory trials, which require the drug regulator's permission, must be registered with the Clinical Trials Registry-India (CTRI) as of 19 March 2019. In this study, for about 300 trials, we aimed to identify the CTRI record that matched the trial for which the regulator had given permission. After identifying 'true pairs', our goal was to determine whether the sites and Principal Investigators mentioned in the permission letter were the same as those mentioned in the CTRI record. We developed a methodology to compare the regulator's permission letters with CTRI records. We manually validated 151 true pairs by comparing the titles, the drug interventions, and the indications. We then examined discrepancies in their trial sites and Principal Investigators. Our findings revealed substantial variations in the number and identity of sites and Principal Investigators between the permission letters and the CTRI records. These discrepancies raise concerns about the accuracy and transparency of regulatory trials in India. We recommend easier data extraction from regulatory documents, cross-referencing regulatory documents and CTRI records, making public the changes to approval letters, and enforcing oversight by Institutional Ethics Committees for site additions or deletions. These steps will increase transparency around regulatory trials running in India.

Outcome of novel pulp capping modalities after full pulpotomy in teeth diagnosed with irreversible pulpitis: A prospective randomized clinical trial.

The study aimed to compare and evaluate the effect of biodentine (BD) alone, BD along with Lyophilised freeze dried platelet rich concentrate (LPC + BD), and BD along with low-level laser therapy (BD + LLLT) after pulpotomy in mature permanent molars with irreversible pulpitis. The study was designed as a randomized, pragmatic, parallel, double-blinded clinical trial registered under the Clinical Trial Registry-India (CTRI/2020/02/023245). 120 permanent molars fulfilling the inclusion and exclusion criteria with symptoms of irreversible pulpitis were randomized after performing pulpotomy into three pulp capping groups: Group 1, BD; Group 2, lyophilized freeze-dried platelet-rich concentrate + BD (LPC + BD); and Group 3, Low level laser therapy + BD Group 3, LLLT + BD. The intergroup comparison was done using one-way analysis of variance followed by the Bonferroni test. The level of significance and confidence interval were 5% and 95%, respectively. Interobserver reliability was measured using Cohen's kappa analysis. At 1 week, there was a significant difference (P < 0.005) observed in the mean postoperative pain levels between the three groups with Group 1 (BD) exhibiting the highest postoperative pain followed by Group 2 (LPC + BD) and least pain was exhibited by Group 3 (LLLT + BD). A similar pattern was observed regarding the analgesic intake with maximum frequency in Group 1 (BD) and least with Group 3 (LLLT + BD). No significant difference in success rates was reported among the groups. Pulpotomy as a treatment option for mandibular molars with irreversible pulpitis has an acceptable clinical success rate; however, long-term overall success rate remains questionable. The outcomes of incorporating adjunctive modalities with BD are remarkable and show tremendous potential for continued development and research.

Submandibular Gland-Sparing Technique Versus En-Bloc Level IB Dissection in Oral Cavity Cancers with N0 Neck Status: A Randomized Controlled Trial.

Metastases to the submandibular gland (SMG) from oral cavity primaries are very rare. Hence, a gland-preserving level IB dissection technique is a feasible option without compromising the lymph node yield (LNY). To assess the feasibility and noninferiority of the SMG-preserving dissection technique to the conventional en bloc removal of level IB in terms of LNY in patients with cN0 oral squamous cell carcinoma (OSCC) undergoing elective neck dissection. Parallel-design, single-center, open-label, randomized controlled trial. Tertiary care health care center-Department of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh. Thirty-eight (n = 38) participants with 46 (n = 46) neck dissection specimens of OSCC were randomly allocated (1:1) into gland-preserving (n1 = 23) and en bloc (n2 = 23) dissection groups. Elective neck dissection comparing SMG-sparing level IB dissection technique versus en bloc level IB dissection. LNY, lymph node density, and level IB operative time in both groups were compared between groups (α < .05). Median LNY (P = .543) and lymph node density (P = 1.000) in level IB did not show significant differences between the groups. LNY in level IB by gland-preserving technique is also not inferior to the conventional en bloc dissection technique (mean difference = 0.217; 95% CI: [-0.597, 1.032]; P = .593). The mean level IB operative time is significantly longer in the gland-preserving group (P < .001). None of the examined SMGs were involved by the tumor. SMG-preserving technique is noninferior to the traditional technique of level IB clearance and can be used in elective neck dissections without compromising the LNY. Functional neck dissection has greatly evolved to decrease patient morbidity, and this method can be adopted in case-specific situations. The trial was registered in the Clinical Trials Registry-India (CTRI/2022/05/042344) on May 2, 2023, https://ctri.nic.in/.

Comparison of Conventional Dose Versus Superdose Platelet-Rich Plasma for Knee Osteoarthritis: A Prospective, Triple-Blind, Randomized Clinical Trial.

Confusion persists regarding the ideal dosage of platelet-rich plasma (PRP) injection for knee osteoarthritis (OA). The purpose of the study was to compare the efficacy of 2 different single-injection PRP dosages in patients with early knee OA-a conventional 4 mL dose and a superdose of 8 mL. It was hypothesized that 8 mL of PRP would be superior to 4 mL of PRP in this patient population. Randomized clinical trial; Level of evidence, 1. Patients with early knee OA (Kellgren-Lawrence grades 1 and 2) who met the inclusion criteria were randomly divided into 2 groups: Group A (n = 50 knees) received a 4-mL PRP injection, and group B (n = 49 knees) received an 8-mL PRP injection, both prepared using the same procedure. Patients were evaluated at the baseline, 6 weeks, 3 months, and 6 months using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the WOMAC-Pain subscale, the visual analog scale for pain, the Knee injury and Osteoarthritis Outcome Score, and patient satisfaction, and results were compared between the groups. The baseline characteristics of the 2 groups were comparable (group A: mean age, 51.96 ± 6.93 years; group B: mean age, 49.12 ± 9.8 3 years). Leucocyte-depleted PRP with 3.5 times concentration (final product platelet concentration, 706.74 × 103-μL) was injected. The mean absolute platelet count injected was 2.82 ± 0.0012 billion in group A and 5.65 ± 0.0022 billion in group B. All patient-reported outcome scores improved significantly in both groups from the baseline to the final follow-up (P < .001), with overall trends and results significantly better in group B than in group A (P < .001). Patient satisfaction at the 6-month follow-up was also better in group B (96%) compared with group A (68%). Short (2 to 7 days) self-limiting complications, such as pain and stiffness, occurred more often in group B (P < .001). Patients with early knee OA had significantly better improvement in pain and function when treated with an 8-mL injection of PRP compared with a 4-mL injection of PRP. The larger dose of PRP had approximately twice the number of platelets. CTRI/2020/02/023403 (Clinical Trials Registry-India identifier).

Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .

Kisspeptin and its Current Clinical Status- A Systematic Review.

Kisspeptin was initially known as metastin for its role in suppressing metastasis in melanoma and breast cancer. Later, based on its ability to stimulate GPR54, its importance in maintaining an intact hypothalamic-pituitary-ovarian axis was recognised, which is the basis for the widespread application of the drug in several conditions such as secondary amenorrhea, regulation of puberty onset, ovarian function, trophoblast invasion, fertility regulation, parturition, and lactation. This systematic study aims to evaluate the current status of kisspentin in clinical trials. The keywords 'kisspeptin' or 'metastin' were used in the clinicaltrials.gov website and Clinical Trial Registry of India (CTRI) to find eligible clinical trials or records carried out without time constraints until February 26, 2023. A total of 33 records were identified through clinical trial databases. All records were screened, and four trials were rejected as they failed to meet the inclusion criteria. Finally, 29 (87.9%) reports of interventional clinical trials with kisspeptin were reviewed. Kisspeptin can be viewed as a multipurpose drug with considerably fewer side effects due to its effects simulating normal physiological processes in our body.

A Randomized Controlled Trial Comparing the Effect of Two-Time Durations of Balloon Compression During Percutaneous Balloon Compression in Resistant Trigeminal Neuralgia

BACKGROUND: Percutaneous balloon compression of the trigeminal nerve’s gasserian ganglion for the treatment of trigeminal neuralgia is an interventional pain procedure with results comparable to microvascular decompression surgery. The procedure is safe in experienced hands and has less morbidity associated with it. However, there is a lack of clear-cut guidelines about the details of the technique like balloon shape, inflation pressure, and duration of inflation. So, keeping the inflation pressure and shape of the balloon constant, we studied the effect of the duration of inflation of the balloon and its effect on pain relief in refractory trigeminal neuralgia cases. OBJECTIVES: To study the outcome with 2 different durations of balloon inflation times in terms of pain relief and complications after percutaneous balloon compression. STUDY DESIGN: Prospective parallel design randomized, controlled trial. SETTING: The study was conducted in a tertiary care hospital in North Eastern India after obtaining approval from the Institutes’ ethics committee (Dean/2018/EC/449). The study was also registered with the Clinical Trials Registry of India (CTRI no. CTRI/2019/03/018166). All patients referred to a pain clinic for unilateral facial pain were screened for the study over 2 years from April 2019 to March 2021. METHODS: Forty patients who met the diagnosis of trigeminal neuralgia and who did not respond satisfactorily to medications were included in the study. They underwent routine blood investigations and a magnetic resonance image of the brain to rule out any medical or surgical conditions. Percutaneous balloon compression was conducted under C-arm guidance using a 12 gauge cannula and a 4 Fr Fogarty balloon was used for compressing the gasserian rootlets. RESULTS: Patients who underwent 90 seconds as well as 120 seconds showed good pain relief. The 2 groups did not show any significant difference in pain relief based on the duration of compression. Visual analog scale scores were reduced from 7-8 to 0-3. Masseter muscle weakness was present in 47.5% of patients post-procedure and recovered in all except one patient. LIMITATIONS: We have followed up with our patients for a short period of 6 months only. We could not measure the intra-luminal compression pressure of the balloon. CONCLUSION: There is no difference in the pain relief obtained by the 2 different durations of compressions. A longer duration of compression, however, has more incidence of side effects. KEY WORDS: Idiopathic trigeminal neuralgia, percutaneous balloon compression, time duration, shape of balloon, masseter muscle weakness, facial numbness, corneal dysesthesia

Using formative research to inform a mental health intervention for adolescents living in Indian slums: the ARTEMIS study

BackgroundAdolescents are vulnerable to stressors because of the rapid physical and mental changes that they go through during this life period. Young people residing in slum communities experience additional stressors due to living conditions, financial stress, and limited access to healthcare and social support services. The Adolescents’ Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) study, is testing an intervention intended to improve mental health outcomes for adolescents living in urban slums in India combining an anti-stigma campaign with a digital health intervention to identify and manage depression, self-harm/suicide risk or other significant emotional complaints.MethodsIn the formative phase, we developed tools and processes for the ARTEMIS intervention. The two intervention components (anti-stigma and digital health) were implemented in purposively selected slums from the two study sites of New Delhi and Vijayawada. A mixed methods formative evaluation was undertaken to improve the understanding of site-specific context, assess feasibility and acceptability of the two components and identify required improvements to be made in the intervention. In-depth interviews and focus groups with key stakeholders (adolescents, parents, community health workers, doctors, and peer leaders), along with quantitative data from the digital health platform, were analysed.ResultsThe anti-stigma campaign methods and materials were found to be acceptable and received overall positive feedback from adolescents. A total of 2752 adolescents were screened using the PHQ9 embedded into a digital application, 133 (4.8%) of whom were identified as at high-risk of depression and/or suicide. 57% (n = 75) of those at high risk were diagnosed and treated by primary health care (PHC) doctors, who were guided by an electronic decision support tool based on WHO’s mhGAP algorithm, built into the digital health application.ConclusionThe formative evaluation of the intervention strategy led to enhanced understanding of the context, acceptability, and feasibility of the intervention. Feedback from stakeholders helped to identify key areas for improvement in the intervention; strategies to improve implementation included engaging with parents, organising health camps in the sites and formation of peer groups.Trial RegistrationThe trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries, Reference number: CTRI/2022/02/040307. Registered 18 February 2022.

Impact of anti-gravity muscle training protocol on plantar pressure, pain threshold and foot posture on chronic painful heel: an RCT study

Abstract Chronic painful heel (CPH) is a symptom of an underlying condition caused due to obesity, excessive foot pronation, tightness of Tendo-Achilles (TA), excessive running, and sedentary life. The antigravity muscles (AGM) atrophy results due to long working hours in sitting, leading to their deteriorating relationship with gravity thereby reduced sensitivity to its force. Hence, need arises to explore training effects of AGM protocol on CPH condition. A randomised controlled trial was conducted on thirty individuals with CPH allocated randomly to two study groups viz. AGMT (n = 15) and Control group (n = 15) who received intervention for twelve sessions over four weeks. Control group received conventional physiotherapy in form of therapeutic ultrasound and exercises while AGMT received conventional physiotherapy using the AGMT protocol. Outcomes assessed were plantar pressure and foot posture assessed using Harris mat, muscle strength by dynamometer, pain threshold with pressure algometer, and foot functions using Foot and Ankle Ability Measure Scale (FAAM) which were taken at pre- and post-training. The between group analysis of data revealed that foot posture, plantar pressure and muscle strength, pain threshold were significantly better in the AGMT group than in the Control group ( 0.0001), while pain intensity (P = 0.3952) and foot functions (P = 0.2372) were equally effective in both the study groups. In conclusion, the AGMT protocol along with conventional physiotherapy proved to be a promising training protocol for individuals with CPH showing positive outcomes in comparison to conventional therapy alone, suggesting to incorporate AGM strengthening alongside conventional therapy to obtain better clinical outcomes. Trial registration: This trial was prospectively registered in the Clinical trial registry of India with registration number CTRI/2022/10/046138.

In Clinical Trials Registry-India, the classification of sponsors needs to be standardised.

In recent years, there has been a big push to register trials, but there are a number of problems with the data in public clinical trial registries. Here, we describe a cross-sectional study of the classification of the primary sponsors of all Phase 2, Phase 2/3, and Phase 3 interventional trials registered with the Clinical Trials Registry-India between May 15, 2016 and May 14, 2021. Data was scraped from the records of CTRI, various filters were applied, and the trials of interest identified. Of 5,453 trials, 105 did not identify a sponsor and 1,080 were sponsored by individuals. Of the remaining 4,268 trials, 427 had unique sponsors, and 3,841 had a total of 350 non-unique sponsors. Of the 350 sponsors, 202 were classified in a single category, and 147 were classified in two or more categories. Overall, of the 3,841 trials, sponsors in 3,537 (92.1%) were classified in one or more of nine well-defined categories, and 304 (7.9%) were classified as various versions of "Other". Three major problems with the sponsor data were identified: each trial does not necessarily list a sponsor, a given sponsor may be categorised in multiple ways, and there has been an excessive use of the "Other" category. Addressing these problems will enable automated analyses of the database, and improve the transparency of the data. Our study generates evidence highlighting the need to improve the trial registration system in India, and perhaps elsewhere.

Low-dose versus standard-dose olanzapine with triple antiemetic therapy for prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with solid tumours: a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial

Olanzapine is an effective antiemetic agent but it results in substantial daytime somnolence when administered at the standard dose. Our aim was to compare the efficacy of low-dose versus standard-dose olanzapine after highly emetogenic chemotherapy in patients with solid tumours. This was a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial done in a tertiary care referral centre in India (Tata Memorial Centre, Homi Bhabha National Institute, Mumbai). Patients aged 13-75 years with an Eastern Cooperative Oncology Group performance status of 0-2, who were receiving doxorubicin-cyclophosphamide or high-dose cisplatin for a solid tumour were eligible. Patients were randomly assigned (1:1), with block randomisation (block sizes of 2 or 4) and stratified by sex, age (≥55 or <55 years), and chemotherapy regimen, to receive low-dose (2·5 mg) oral olanzapine or standard-dose (10·0 mg) oral olanzapine daily for 4 days, in combination with a triple antiemetic regimen. Study staff were masked to treatment allocation but patients were aware of their group assignment. The primary endpoint was complete control, defined as no emetic episodes, no rescue medications, and no or mild nausea in the overall phase (0-120 hours), assessed in the modified intention-to-treat (mITT) population (ie, all eligible patients who received protocol-specified treatment, excluding those who had eligibility violations and who withdrew consent after randomisation). Daytime somnolence was the safety endpoint of interest. Non-inferiority was shown if the upper limit of the one-sided 95% CI for the difference in the complete control proportions between the treatment groups excluded the non-inferiority margin of 10%. This study is registered with the Clinical Trial Registry India, CTRI/2021/01/030233, is closed to accrual, and this is the final data analysis. Between Feb 9, 2021, and May 30, 2023, 356 patients were pre-screened for eligibility, of whom 275 patients were enrolled and randomly assigned (134 to the 2·5 mg olanzapine group and 141 to the 10·0 mg olanzapine group). 267 patients (132 in the 2·5 mg group and 135 in the 10·0 mg group) were included in the mITT population, of whom 252 (94%) were female, 15 (6%) were male, and 242 (91%) had breast cancer. 59 (45%) of 132 patients in the 2·5 mg olanzapine group had complete control in the overall phase versus 59 (44%) of 135 in the 10·0 mg olanzapine group (difference -1·0% [one-sided 95% CI -100·0 to 9·0]; p=0·87). In the overall phase, there were significantly fewer patients in the 2·5 mg olanzapine group than in the 10·0 mg olanzapine group with daytime somnolence of any grade (86 [65%] of 132 vs 121 [90%] of 135; p<0·0001) and of severe grade on day 1 (six]5%] vs 54 [40%]; p<0·0001). Our findings suggest that olanzapine 2·5 mg is non-inferior to 10·0 mg in antiemetic efficacy and results in reduced occurrence of daytime somnolence among patients receiving highly emetic chemotherapy and should be considered as a new standard of care. Progressive Ladies Welfare Association.

Psychiatric disorders in older adults with cancer referred to psycho-oncology service in a tertiary care cancer centre: a 7-year real world experience from India

BackgroundCancer affects mental health in older adults with cancer (OAC), affecting almost 50% of the patients. There are only a few studies on psychiatric disorders in OAC, especially in low resource settings. We report on our real-world experience of prevalence of and factors associated with psychiatric disorders in OAC referred to a psycho-oncology service in an Indian tertiary care cancer institute.MethodsWe retrospectively analysed medical and psycho-oncology records of patients aged 60 + on cancer-directed treatment or follow-up for < 2 years after treatment completion, referred to psycho-oncology services in a tertiary care cancer centre in Mumbai, India, from Jan 2011-Dec 2017. We recorded sociodemographic, clinical, and treatment-related variables, as well as past psychiatric disorders. The ICD-10 was used to record current psychiatric disorder type and presence. IBM SPSS version 24 (Armonk, NY, USA) was used for descriptive measures, tests of association, and logistic regression analysis. The study protocol was approved by Institutional Ethics Committee and registered with the Clinical Trials Registry-India (CTRI/2020/06/026095).ResultsOf 763 patients included in the study, 475 (62.3%) were males and 436 (57.1%) were inpatients, with a median age of 65 years. 93% of the patients had a solid tumour and 207 (27.1%) had a history of psychiatric disorder. A current psychiatric diagnosis was noted in 556 patients (72.9%) on initial presentation, of which adjustment disorders, delirium and depression and anxiety disorders were most frequently seen in 25.2%, 21% and 11.1%, respectively. On univariate analysis, a past history of psychiatric disorders (χ2 = 34.6, p < 0.001), lower performance status (χ2 = 9.9, p = 0.002) and haematolymphoid malignancy (χ2 = 4.08, p = 0.04) significantly increased the risk of current psychiatric diagnosis. Logistic regression confirmed these variables as significant.ConclusionOlder adults with cancer referred to psycho-oncology services have high rates of psychiatric disorders at their initial presentation, mainly adjustment disorders, delirium and depression and anxiety. A past history of psychiatric disorders, lower performance status and haematolymphoid cancers significantly increased the risk of psychiatric disorders. Multidisciplinary psycho-oncology teams including a psychiatrist should be integrated in comprehensive care of this group of patients. Further research outcomes and effect of psycho-oncological interventions is required in older adults with cancer in LMIC settings.

Safety and efficacy of N-acetylcysteine (NAC) as an adjunct to standard treatment in patients with acute ischemic stroke: a randomized controlled pilot trial (NACTLYS)

There is a pressing clinical need for thrombolytic agents that can effectively disaggregate arterial thrombi in acute ischemic stroke without significantly increasing the risk of bleeding. This pilot study aimed to investigate the safety and efficacy of N-acetylcysteine (NAC) as an adjunctive therapy to intravenous recombinant tissue plasminogen activator (rtPA or alteplase). A randomized, open-label, blinded assessor pilot study was conducted. Patients presenting with an acute ischemic stroke within 4.5 h from onset were randomized into two groups: intravenous NAC and rtPA or rtPA alone. Primary outcomes included intracerebral hemorrhage, symptomatic intracerebral hemorrhage, extracranial bleeding, and adverse reactions. Secondary outcomes comprised major neurological improvement assessed by (National Institute of Health Stroke Scale) NIHSS at 24 h, recanalization on first run of angiography in patients who underwent thrombectomy or on repeat vascular imaging at 24 h, modified Rankin scale, and three-month mortality. Forty patients were enrolled, with 21 receiving only rtPA and 19 receiving NAC with rtPA. Baseline characteristics were comparable among groups. No significant differences were observed in adverse events (p = 0.99), intracranial hemorrhage (p = 0.21), symptomatic intracerebral hemorrhage (p = 0.47), or extracranial bleeding (p = 0.21). Median NIHSS at 24 h was significantly lower in the intervention group (p = 0.03). Functional outcomes and three-month mortality were similar between groups (p = 0.85 and p = 0.99 respectively). The co-administration of N-acetylcysteine with alteplase did not significantly alter safety profiles, morbidity, or mortality at 3 months. While no substantial differences were noted, a slightly improved early neurological outcome was observed in the intervention arm. The study's findings were constrained by a small sample size, emphasizing the necessity for future large-scale trials to comprehensively evaluate the safety and efficacy of N-acetylcysteine as a thrombolytic agent in acute ischemic stroke.Trial Registration Clinical Trials Registry India—CTRI/2019/05/019305.

Effectiveness of dynamic neuromuscular stabilization, neurodevelopmental techniques and proprioceptive neuromuscular facilitation on trunk and gait parameters in patients with subacute stroke: A three-arm parallel randomised clinical trial

Background Today, stroke is the principal cause of demise in both developed and developing countries. There are different techniques used to treat patients with sub-acute stroke. Trunk muscles play a key role, i.e. in keeping the spine and trunk in place. This stabilization requires moving the head and extremities freely and selectively. The aim of this study is to compare the effectiveness of dynamic neuromuscular stabilization (DNS), neurodevelopmental techniques (NDT) and proprioceptive neuromuscular facilitation (PNF) on trunk and gait parameters in the subacute phase of stroke. This study is intended to ascertain the efficacy of all three approaches individually and to compare the effectiveness of DNS, NDT and PNF on trunk and gait parameters. Furthermore, the findings of this study could be used to assist post-stroke survivors in their early recovery and improve their level of independence. Methods In this interventional study, participants will be divided into three groups, and in each group, 20 patients will be assigned randomly to each group using the sequentially numbered opaque sealed envelope method. Group A patients will be given DNS, Group B will be given NDT, and Group C will be given PNF. The patients will be given treatment for five days for four consecutive weeks. Outcome measures that will be used are trunk impairment scale (TIS), dynamic gait index (DGI) and gait parameters. Data will be collected before and after the 4-week treatment period. Conclusions After the study, a conclusion will be drawn regarding which treatment technique is most suitable among all the three strategies for treating stroke patients if the hypothesis of the study is found valid. Clinical Trials Registry – India (CTRI) reference no. CTRI/2022/06/043037; date of registration 22/05/2022.

Hand assistive device with suction cup (HADS) technology for poststroke patients.

A stroke is a neurological disease that primarily causes paralysis. Besides paraplegia, all other types of paralysis affect the upper extremity. Advanced technologies, such as wearable devices and rehabilitation regimens, are also being developed to enhance the functional ability of a stroke person to grasp and release daily living objects. In this research, we developed a rehabilitation functional assist device combining a flexion and extension mechanism with suction cup technology (hybrid technology) to help post-stroke patients improve their hand grip strength in day-to-day grasping activities. Ten poststroke hemiplegia patients were studied to test the functional ability of the impaired hand by wearing and not wearing the device. The outcomes were validated by three standard clinical tests, such as the Toronto Rehabilitation Institute - Hand Functional Test (TRI-HFT), the Chedoke Arm Hand Activity Inventory (CAHAI-9), and the Fugl-Meyer Assessment (FMA) with overall score improvements of 14.5 ± 3.8-25 ± 2.2 (p = 0.005), 5.4 ± 2.8-10 ± 1.6 (p = 0.008), and 9.6 ± 2.6-17 ± 2.4 (p = 0.005) respectively. The p-value for each of the three evaluations was less than 0.05, indicating significantly improved results and the average feedback score of the participants was 3.8 out of 5. The proposed device significantly increased impaired hand functionality in post-stroke patients. The subjects could complete some of the grasping tasks that they could not grasp without the device.Clinical trial registrationThe Clinical Trial Registry of India approved the work CTRI/2022/02/040495 described in this manuscript.

Opioid use disorder and role of yoga as an adjunct in management (OUDARYAM): Study protocol for a randomized controlled trial.

The proposed research aims to test the effects and mechanisms of a six-month yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study with the following primary outcome variables: 1) clinical: abstinence (opioid negative urine test), and reductions in pain and craving, and 2) mechanisms: reward circuit activation in response to opioid visual cue craving paradigm, activation in response to a cognitive control task, and resting state functional connectivity through fMRI, and plasma beta-endorphin levels. Secondary outcome variables are perceived stress, anxiety, sleep quality, cognitive performance, pain threshold, buprenorphine dosage and side effects, withdrawal symptoms, socio-occupational functioning, vedic personality traits, heart rate variability, serum cortisol, and brain GABA levels through magnetic resonance spectroscopy (MRS). In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 164 patients with OUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (standard treatment + yoga-based intervention), or waitlist group (standard treatment alone). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized yoga program for OUD will be used as an intervention. Participants in the yoga arm will receive 10 supervised in-person sessions of yoga in the initial two weeks followed by tele-yoga sessions thrice a week for the next 22 weeks. The wait-list control group will continue the standard treatment alone for 24 weeks. Assessments will be done at baseline, two weeks, 12 weeks, and 24 weeks. Data from all randomized subjects will be analysed using intent-to-treat analysis and mixed model multivariate analysis. Findings will be disseminated through peer-reviewed publication, conference presentations, and social media. The trial has been registered under Clinical Trials Registry-India with registration number CTRI/2023/03/050737.