STUDY PROTOCOL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1657004
This article is part of the Research TopicThe Increasing Relevance of Traditional Medicine Systems for the Primary Health Care Sector and General Practice: Global Research Perspectives – Volume IIView all 23 articles
"An Exploratory Randomized, Double-Blind, Placebo-Controlled Trial Protocol on Combined Cognitive Behavioral Therapy and Adjunct Brahmi (Bacopa monnieri) Tablets in Premenstrual Syndrome Management"
Provisionally accepted
Shahina .1,2Hemavathi Shivapura Krishnarajabhatt1,2Cinu Mithra Nisa Sushilal Nisa Sushilal1,2
Parvathy Unnikrishnan1,2*- 1Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham University, AMRITAPURI, India
- 2Amrita Vishwa Vidyapeetham Amrita School of Ayurveda, Kollam, India
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Premenstrual syndrome (PMS) is a widespread and under-recognised disorder, characterised by cyclical recurrence of physical, psychological, and behavioral symptoms during the luteal phase, significantly impacting the daily functioning of women. Cognitive Behavioral Therapy (CBT) is an established non-pharmacological strategy for PMS, while Brahmi (Bacopa monnieri), a classical Ayurvedic herb, has traditionally been used to enhance cognition, reduce anxiety, and support emotional balance. This exploratory study evaluates whether combining Brahmi with CBT offers additional benefit compared to CBT alone. It is a double-blind, randomized, placebo-controlled exploratory clinical trial (CTRI/2025/02/081239) conducted at the Amrita School of Ayurveda, Kollam, Kerala, with sponsorship from the Central Council for Research in Ayurveda Sciences (CCRAS). Forty-six women aged 18–24 years, diagnosed with moderate to severe PMS using the Premenstrual Symptoms Screening Tool (PSST) and the Daily Record of Severity of Problems (DRSP), will be recruited and randomly assigned to receive either CBT with Brahmi tablets or CBT with placebo tablets. The primary outcomes include reduction in PMS severity, assessed by DRSP, and improvement in quality of life measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q SF). Secondary outcome is reduction in functional disability measured using the Sheehan Disability Scale. Assessments will be conducted at baseline, during treatment, and at follow-up. Statistical analysis will be carried out using repeated measures ANOVA with Bonferroni-adjusted post hoc tests, significance set at p < 0.05, and effect sizes reported. A limitation of this design is that it cannot disentangle the individual effects of Brahmi from CBT, allowing conclusions only on the combined intervention. The study aims to generate preliminary exploratory evidence for a safe, integrative, and accessible approach to PMS management in young women.
Keywords: cognitive behavioral therapy, Bacopa monnieri, Ayurveda, Clinical Trial, Integrative Medicine, Premenstrual Syndrome
Received: 30 Jun 2025; Accepted: 02 Sep 2025.
Copyright: © 2025 ., Krishnarajabhatt, Nisa Sushilal and Unnikrishnan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Parvathy Unnikrishnan, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham University, AMRITAPURI, India
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