| CTRI Number |
CTRI/2024/07/071063 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of premenstrual depression |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect Of
medhya rasayana in premenstrual dysphoric disorder in college
going Students
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMYA E A |
| Designation |
PhD scholar |
| Affiliation |
G J Patel Institute Of Ayurvedic Studies And Research |
| Address |
Room No 14 OPD
Department of Kayachikitsa
S G Patel Ayurveda Hospital And Maternity Home
G J Patel Institute Of Ayurvedic Studies And Research
---
Anand
GUJARAT
388121
India |
| Phone |
9847003989 |
| Fax |
-- |
| Email |
souvijay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manchak V Kendre |
| Designation |
Professor |
| Affiliation |
G J PATEL INSTITUTE OF AYURVEDIC STUDEIS AND RESEARCH |
| Address |
KAYACHIKITSA DEPARTMENT
G J PATEL INSTITUTE OF AYURVEDIC STUDEIS AND RESEARCH
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
- |
| Email |
manchak.kendre@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manchak V Kendre |
| Designation |
Professor |
| Affiliation |
G J Patel Institute Of Ayurvedic Studies And Research |
| Address |
G J Patel Institute Of Ayurvedic Studies And Research
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
- |
| Email |
manchak.kendre@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| G J Patel Institute Of Ayurvedic Studies And Research
New V V Nagar
GIDC
Anand
388121 |
|
|
Primary Sponsor
|
| Name |
G J Patel Institute Of Ayurvedic Studies And Research |
| Address |
G J Patel Institute Of Ayurvedic Studies And Research |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SOUMYA E A |
S G PATEL AYURVEDA HOSPITAL AND MATERNITY HOME |
ROOM NO 14 DEPARTMENT OF KAYACHIKITSA S G PATEL AYURVEDA HOSPITAL ANND MATERNITY HOME;G J PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH NEW V V NAGAR ANAND
Anand
GUJARAT |
9847003989
--
souvijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G J Patel Institute Of Ayurvedic Studies And Research;S G Patel Ayurveda hospital and maternity homeINSTITUITIONAL (HUMAN) ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MEDHYA RASAYANA, Reference: CHARAKA SAMHITHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: NIL | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: JATAMAMSI CHURNA, Reference: PRIYA NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Female |
| Details |
College going female students age ranging from 18 to 26 years
Regular menstruation of 28-to-35-day cycle
Those who satisfy the diagnostic criteria as per DSM-5 criteria for PMDD; and those who complete
the DRSP Questionnaire for 2 consecutive cycles |
|
| ExclusionCriteria |
| Details |
Participants with other psychiatric disorders (Psychosis, bipolar disorder, Anxiety disorder,OCD).
PMDD Participants with suicidal tendency/ thought
Participants with severe dysmenorrhea
Participants with irregular period and absence of menstruation for 3 consecutive cycles
Those who are under medication for PMDD
Those who are having premenstrual syndrome
Those who are on Oral contraceptives
Those who need immediate medical care
Known cases of Type 2DM, Hypertension, Autoimmune disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Medhya rasayana may have impact on reducing total DRSP Score. |
90DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve academic performance |
30th day, 60th day, 90th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual dysphoric disorder is a chronic disorder expected to last until menopause, long-term safety of therapeutic interventions is a major concern. So, it is the need of hour to find out an easily accessible and inexpensive treatment with minimal side effect Medhya rasayana is having the property of improving mental health (Medhya), correcting Agni (Agni vardhana), as well as curing the disease (Amaya nashini) can be considered as a drug of choice in Premenstrual dysphoric disorder (PMDD) as mental as well as physical well-being is affected in premenstrual dysphoric disorder |