A double-blind randomized placebo-controlled clinical trial to compare the effect of Cognitive Behavioral Therapy with and without the oral administration of Brahmi tablet in the management of Pre-Menstrual Syndrome (PMS)

PROPOSED TITLE:

A double-blind randomized placebo-controlled clinical trial to compare the effect of Cognitive Behavioral Therapy with and without  the oral administration of Brahmi tablet in the management of Pre-Menstrual Syndrome (PMS)

INTRODUCTION:

According to ACOG, "Many women feel physical and mood changes during the days before menstruation. When these symptoms happen month after month and affect a woman’s normal life, It is known as Pre-Menstrual syndrome (PMS)". The multimodal management of PMS includes pharmacotherapies (combined oral contraceptive pills and SSRIs), psychological interventions (Cognitive Behavioral Therapy), and lifestyle modifications. Cognitive Behavioral Therapy (CBT) is a well-established approach that emphasizes correcting unsettled disruptive thoughts, behaviors, and emotions. At a primary glance, no direct Ayurvedic reference to PMS is seen in Striroga Prakarana in any classics. On thorough search and evaluation, the various Vatavriddhi Lakshana, Pittavriddhi Lakshana, Kaphavriddhi Lakshana, and the Lakshana of Udavarta due to Apathya can be considered under the umbrella term of PMS. Severe conditions where PMS leads to Pre-Menstrual Dysphoric Disorder, Vata Nirodhaja Udavarta Lakshana, Chittoddvega, and some Vataja Unmada Lakshana can be seen. Ayurvedic classics have indicated Brahmi (Bacopa monnieri) as Medhya, Rasayani, and Smritiprada and is advised in Unmada, Apasmara, Swarabhanga and Mansika Daurbalya. So, it is chosen as a trial drug for the management of PMS. CBT is widely considered as an effective treatment for PMS. This study aims to evaluate the combined effect of oral administration of Brahmi tablets and CBT in managing PMS for better results.

METHODOLOGY:

With the permission of the Institutional Ethics Committee, 46 participants will be selected from OPD and IPD of Amrita Ayurveda Hospital satisfying the inclusion criteria. After obtaining informed consent, screening for 2 menstrual cycles will be done and participants with moderate to severe PMS will be allocated into groups using simple random method sampling (block randomization). Double blinding will be performed to reduce the bias. The trial group will receive CBT with 500 mg of Brahmi tablet and the control group will receive CBT with 500 mg of placebo tablet for 2 menstrual cycles.

DURATION OF THE STUDY: 20 months

ESTIMATED COST:  50,000/-