| CTRI Number |
CTRI/2023/07/055516 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Pre-Menstrual Symptoms with the help of Brahmi churna and Jatamansi churna capsule |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of Brahmi Churna Capsule And Jatamansi Churna Capsule In Pre-Menstrual Syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Mahesh Vijay Patil |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD No-104 and IPD Department Of PTSR Parul Institute Of Ayurveda Parul University PO Limda
Vadodara
GUJARAT
391760
India |
| Phone |
7498364916 |
| Fax |
|
| Email |
maheshp703@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr.Vrushalee Dodke |
| Designation |
Professor, Department Of Prasuti-Tantra Evum Stri-Roga |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD No-104 and IPD Department Of PTSR Parul Institute Of Ayurveda Parul University PO Limda
Vadodara
GUJARAT
391760
India |
| Phone |
09823088621 |
| Fax |
|
| Email |
vrushaleedodke@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr.Vrushalee Dodke |
| Designation |
Associate Professor, Department Of Prasuti-Tantra Evum Stri-Roga |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD No-104 and IPD Department Of PTSR Parul Institute Of Ayurveda Parul University PO Limda
Vadodara
GUJARAT
391760
India |
| Phone |
09823088621 |
| Fax |
|
| Email |
vrushaleedodke@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No-104 And IPD Department of PTSR Parul Institute of Ayurveda Parul University PO Limda Pin code-391760 Vadodara Gujarat India |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda |
| Address |
OPD No-104 And IPD Department of PTSR Parul Institute of Ayurveda Parul University PO LimdaPin code-391760
Vadodara Gujarat India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mahesh Vijay Patil |
Parul Institute Of Ayurveda |
OPD No-104 And IPD Department of PTSR Parul Institute of Ayurveda Parul University PO Limda Pin code-391760
Vadodara
Vadodara
GUJARAT |
7498364916
maheshp703@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute Of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: APANAVRUTA-VYANAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamansi (Nardostachys Jatamansi), Reference: Ayurvedic Pharmacopoeia of India , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - Luke warm water ), Additional Information: - Jatamansi churna capsule 500mg each 2 capsule TID given to patient after meal with Luke warm water for 2 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi ( Bacopa monnieri), Reference: Ayurvedic Pharmacopoeia of India , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - Luke warm water ), Additional Information: - Brahmi churna capsule 500mg each 2 capsule TID given orally with Luke warm water for 2 months. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 18 yrs to 40 yrs of age irrespective of socio economic status and in good medical health
2. Female subjects having regular menstrual cycle with cycle length of 21-35 days.
3. Having a minimum PMTS score >10 and VAS score >1
4. Symptoms should appear at definite time in luteal phase of the cycle.
5. The subject should be symptomatic for a period of last 3 or more than 3 months.
6. Symptoms should not persist beyond the 5th day of menstrual cycle.
7. The subjects who are ready to follow the treatment protocol and sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1. Women aged below 18 and above 40 years
2. Subject suffering from other acute or chronic psychiatric illness.
3. Those with symptoms existing less than 3 menstrual cycles.
4. Subjects having diabetes mellitus, hypertension, thyroid, PCOS, DUB
5. Subjects suffering from organic brain diseases.
6. Subjects under hormonal and psychiatric treatment.
7. Subjects taking oral contraceptive pills.
8. Subjects with premenstrual dysphoric disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To subside Pre-Menstrual Symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life. |
The outcomes will be measured after screening at Base Line BT after 1 month & at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd month after 1 month of medicine free period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aetiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow Various hypotheses are postulated to explain the etiopathogenesis of PMS. Brahmi churna is very effective in psycho-neuro-endocrinal symptoms which relieves that symptoms and improves quality life of female. Patients will be assesed on the basis of 1 PMS self rating scale 2.PMS Observer rating scale 3.PMS Vas scale
|