FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081239 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening
Behavioral
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A 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) 
Scientific Title of Study   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) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shahina 
Designation  1st year PG Scholar  
Affiliation  Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Kollam Kerala 
Address  Dept of Prasuti Tantra and Stri Roga Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Campus Clappana PO Kollam Kollam KERALA 690525 India

Kollam
KERALA
690525
India 
Phone  9518034835  
Fax    
Email  shahina151999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parvathy Unnikrishnan 
Designation  Associate professor 
Affiliation  Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Kollam kerala 
Address  Dept of Prasuti Tantra and Stri Roga Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Campus Clappana PO Kollam Kollam KERALA 690525 India

Kollam
KERALA
690525
India 
Phone  9497882774  
Fax    
Email  parvathyunnikrishnannair@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parvathy Unnikrishnan 
Designation  Associate professor 
Affiliation  Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Kollam Kerala 
Address  Dept of Prasuti Tantra and Stri Roga Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Campus Clappana PO Kollam Kollam KERALA 690525 India

Kollam
KERALA
690525
India 
Phone  9497882774  
Fax    
Email  parvathyunnikrishnannair@gmail.com  
 
Source of Monetary or Material Support  
Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Campus Clappana PO Kollam Kollam KERALA 690525 India 
 
Primary Sponsor  
Name  Dr Shahina  
Address  Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Campus Clappana PO Kollam Kollam KERALA 690525 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shahina   Amrita School of Ayurveda  Dept of Prasuti Tantra and Stri Roga Amrita school of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana Kollam Kerala 690525
Kollam
KERALA 		 9518034835

shahina151999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: UDAVARTAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Brahmi, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
2Comparator Arm (Non Ayurveda)-Cognitive Behavioral Therapy. (CBT)the comparator group will be given CBT for 2 menstrual cycles. Therapy sessions in the menstrual cycle will be on Day 5 Day 12 Day 19 and Day 26. A total of 8 sessions will be conducted in menstrual cycles.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  Participants from 18 to 24 years of age having regular menstruation with a menstrual interval of 25-35 days from the past 6 months.
Scoring below 10 on the PHQ 9 depression scale.
Diagnosed with moderate to severe PMS through Premenstrual Syndrome Screening Tool (PSST).
The diagnosis confirmed with screening by DRSP scale for 2 menstrual cycles.
Participants willing to participate. 
 
ExclusionCriteria 
Details  Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus.
Under medication for any psychological or psychiatric disorders.
Any substance use.
Current PMS/PMDD treatment.
Known case of pelvic pathology.
Planning to conceive during the study period.
Hormonal therapy.
No access to mobile phones and internet. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in severity of daily problems using the DRSP scale.
2. Improvement in quality of life using Q-LES-Q SF.
 		 1. Virtual screening, visit 1, visit 2, and visit 3.
2. visit 1, visit 2, and visit 3.

 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the disability to function during PMS-related menstruation using the SDS tool.  Visit 1, visit 2, and visit 3.
 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [parvathyunnikrishnannair@gmail.comgmail.com].

  6. For how long will this data be available start date provided 12-01-2026 and end date provided 12-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   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/-


 
Close