"An exploratory randomized, double-blind, placebo- controlled trial protocol on combined Cognitive Behavioral Therapy...

Premenstrual syndrome (PMS) is a widespread and under-recognized disorder, characterized 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.