| CTRI Number |
CTRI/2025/09/094047 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Dhatriphaladi yoga and Guduchyadi yoga in Rajonivrutti w.s.r to Menopausal syndrome |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Dhatriphaladi yoga and Guduchyadiyoga in Rajonivrutti w.s.r to Menopause |
| 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 Piyusha Subhash Patil |
| Designation |
Post graduate resident in Prasuti evam stree roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Center, Ankali-591213 |
| Address |
Room No-1,Department of Prasuti tantra evum stree roga Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213 Taluk-chikodi, Dist- Belgaum
KARNATAKA
591213
India
Belgaum
KARNATAKA
591213
India |
| Phone |
8329241850 |
| Fax |
|
| Email |
piyushapatil2223@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Vandana S Kulkarni |
| Designation |
Professor and HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213 |
| Address |
Room No-1,Department of Prasuti Tantra Evum Stree Roga,Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213, Taluk-chikodi, Dist- Belgaum
KARNATAKA 591213
India
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drvandanaskulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrs Vandana S Kulkarni |
| Designation |
Professor and HOD Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213 |
| Address |
Room No-1,Department of Prasuti Tantra Evum Stree Roga,Dr.N.A.Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213, Taluk-chikodi, Dist- Belgaum
KARNATAKA 591213
India
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drvandanaskulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.N A Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213,Chikodi Taluk,Belagavi District,Karnataka State,India country. |
|
|
Primary Sponsor
|
| Name |
Dr Piyusha Subhash Patil |
| Address |
Dr.N A Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213,Chikodi Taluk,Belagavi District,Karnataka State,India country. |
| Type of Sponsor |
Other [self] |
|
|
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 Piyusha Subhash Patil |
Dr.N A Magadum Ayurvedic Medical College,Hospital and Research Centre Ankali 591213 |
Prasuti tantra and stree roga department OPD no 1
Belgaum
KARNATAKA |
8329241850
piyushapatil2223@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.N A Magadum Ayurvedic Medical College,Hospital and Research centre Ankali- 591213,Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rajonivrutti wsr to Menopause |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatriphaladi Yoga, Reference: YOGA RATNAKARA, Rasayana adhikarana , uttarardha Vol. II edited by Dr. Madham Shetty Suresh Babu, CHOWKHAMBA SANSKRIT SERIES, VARANASI 2018 pg. 1249, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Milk ), Additional Information: No any | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Yoga, Reference: YOGA RATNAKARA, Rasayana adhikarana , uttarardha Vol. II edited by Dr. Madham Shetty Suresh Babu, CHOWKHAMBA SANSKRIT SERIES, VARANASI 2018, pg. 1249, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: No any |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women having age between 45 to 55 and attained menopause Menopausal symptoms developed as mentioned in subjective criteria like Hot flushes Excessive sweating Fatigue Palpitations Dyspareunia Irritability Mood swings Sleep disturbance |
|
| ExclusionCriteria |
| Details |
Premature menopause (before 40 years)
Delayed menopause (after 55 years)
Malignancy and other systemic diseases
Artificial menopause (surgical menopause) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hot flushes Excessive sweating Fatigue Palpitations Dyspareunia Irritability Mood swings Sleep disturbance |
2 months at interval of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the signs and symptoms and test the efficacy of drug |
2 months at interval of 1 month |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
The present title ’’A Comparative clinical study to evaluate the efficacy of Dhatriplaladi Yoga and Guduchyadi Yoga in Rajonivrutti w.s.r to Menopausal Syndrome’’ will be conducted on 60 women between age 45 to 55 with 30 women in each group with mentioned subjective and objective criteria. One group will be treated with Dhatriphaladi Yoga 5gm with milk and other group will be treated with Guduchyadi Yoga 5mg with milk. assessment and investiagtions will be done once in a month for 2 months and follow up of once in a month for 2 months will be done. |