#ClinicalTrial

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Ayurvedic Treatment for Lumbar Disc Herniation With Radiculopathy: #Protocol for a #RCT #ClinicalTrial

Background: The leading cause of disability worldwide is low back pain. The incidence of herniated disc is approximately 5 to 20 cases per 1000 adults per year, and herniated disc is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, the condition grudhrasi is considered analogous to radiculopathy. In conventional medicine, the first line of treatment includes conservative management, such as patient education, manual therapy, and nonsteroidal anti-inflammatory drugs. Ayurvedic treatments are used to manage lumbar radiculopathy. Objective: This clinical #Study aims to compare the safety and efficacy of an Ayurvedic treatment #Protocol with standard care in patients with lumbar disc herniation with radiculopathy. Methods: This is an open-label, randomized, controlled, parallel group clinical trial with a sample size of 80 participants who will be randomly allocated to 2 groups. The intervention group will receive an Ayurvedic treatment #Protocol, and the control group will be treated with conventional care, including physiotherapy, for a period of 60 days. The changes in the numeric pain rating scale and visual analog scale score and the Oswestry Disability Index (version 2.0) score will be considered the primary outcome measures and will be recorded at baseline (day 1) and on day 8 (after completing inpatient [IP] treatment), day 30, and day 60. The secondary outcome, quality of life, will be recorded at baseline (day 1) and on day 8 (after completing IP treatment), day 30, and day 60. The occurrence of adverse events and the need for rescue analgesic medications will be considered other secondary outcome measures and will be recorded on day 8 (after completing IP treatment), day 30, and day 60. Results: The #Study was funded in March 2023, and the #Study period is 36 months. Participant enrollment began in November 2023. A total of 136 participants were screened, of whom 80 were enrolled in the #Study. Data analysis is in progress, and the #Study outcomes are expected to be published by December 2026. Conclusions: The outcome of this trial may provide scientific evidence regarding the safety and efficacy of Ayurvedic treatment for lumbar disc herniation with radiculopathy. The #Study may also contribute to the development of evidence-based integrative management strategies and standardized treatment #Protocols for this condition. Trial Registration: Clinical Trial Registry of India CTRI/2023/05/052859; https://tinyurl.com/y6h4b5kb

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Effects of a Nutritionally Balanced Between-Meal Food Product on Brain Function in Older Adults: #Protocol for a #RCT #ClinicalTrial (the MiniMeal #Study)

Background: Increasing evidence suggests that diet influences gut microbiota composition and systemic inflammation, which in turn may affect brain health, cognitive function, and mood regulation. Elevated levels of systemic inflammation have been associated with reduced resting-state functional connectivity within the default mode network, a pattern linked to poorer cognitive performance in older adults. Dietary interventions incorporating anti-inflammatory foods, such as oat bran and chickpeas, may help attenuate low-grade inflammation and promote healthier dietary behaviors in aging populations. Objective: This #Study #Protocol describes a #RCT #ClinicalTrial designed to investigate the effect of healthy between-meal products on brain activity in older adults. Methods: The MiniMeal #Study is a 9-week, 3-arm #RCT #ClinicalTrial comprising a blinded, 2-arm intervention and a nonblinded, no-intervention comparison group. A total of 114 community-dwelling men and women aged ≥70 years (38 per group) will be randomized to 1 of 3 #Study arms. Participants in the intervention group will consume the MiniMeal products, while those in the reference or control group will receive reference or control products. In both intervention arms, products will be consumed twice daily, either replacing or supplementing habitual morning, afternoon, or evening between-meal occasions. All other dietary habits will remain unchanged. Participants in the no-intervention group will maintain their habitual diet throughout the #Study period. The primary outcome is functional brain activity, assessed using functional magnetic resonance imaging during the n-back task, comparing the intervention and reference groups. Secondary outcomes include comparisons with the no-intervention group and assessment of other neural measures, biomarkers in blood, body composition, physical function, and self-reported well-being. Results: Ethics approval was obtained from the Swedish Ethical Review Authority (Etikprövningsmyndigheten) on February 20, 2024. Participant recruitment was completed on December 18, 2025. Data collection was completed by February 27, 2026. Data analysis is ongoing since January 7, 2026. A total of 114 participants were enrolled, of whom, 106 completed all 6 #Study visits. Conclusions: This #Study will provide insights into whether nutritious between-meal products influence brain function in older adults and will explore potential underlying biological mechanisms. The findings are expected to contribute to a better understanding of the relationship between dietary habits and cognitive health in older adults and may inform future #Research on diet-based strategies to support in healthy aging. Trial Registration: ClinicalTrials.gov NCT06353984; https://clinicaltrials.gov/#Study/NCT06353984

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Efficacy of Combining Conventional Physiotherapy for Migraine With Transcutaneous Stimulation of the Auricular Vagal Nerve or Supraorbital Nerve: #Protocol for a #RCT #ClinicalTrial

Background: Migraine is a common and disabling neurological disorder characterized by recurrent headaches and associated symptoms that significantly affect quality of life. Conventional physiotherapy plays a supportive role in migraine management; however, it may not adequately address central sensitization and altered pain modulation. Noninvasive neuromodulation techniques, such as transcutaneous auricular vagal nerve stimulation (ta-VNS) and transcutaneous supraorbital nerve stimulation (t-SNS), have shown potential in modulating central pain pathways and reducing migraine burden. Objective: The primary objective of this #Study is to evaluate and compare the effectiveness of ta-VNS and t-SNS, each combined with conventional physiotherapy, in reducing pain intensity and migraine frequency in individuals with migraine. Secondary objectives include assessing their effects on migraine disability, neck disability, and cervical range of motion. Methods: This #RCT #ClinicalTrial will include individuals clinically diagnosed with migraine. Participants will be randomly allocated into 2 groups: group A will receive ta-VNS along with conventional physiotherapy, and group B will receive t-SNS along with conventional physiotherapy. Both interventions will be administered for a defined treatment period. Outcome measures will be recorded at baseline, immediately after the intervention, and during follow-up periods to evaluate short- and long-term effects. Results: It is anticipated that both ta-VNS and t-SNS, when combined with conventional physiotherapy, will lead to significant improvements in pain intensity, migraine frequency, and functional outcomes. One neuromodulation technique may demonstrate greater or more sustained benefits than the other. Conclusions: This #Study is expected to provide comparative evidence on the effectiveness of ta-VNS and t-SNS as adjuncts to conventional physiotherapy in migraine management. The findings may support the inclusion of targeted noninvasive neuromodulation techniques in physiotherapy-based treatment #Protocols for migraine. Clinical Trial: Clinical Trials Registry–India CTRI/2026/01/100045; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ3Mjgz&Enc=&userName=