| CTRI Number |
CTRI/2025/12/099723 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of shatapushpa kalpa and varunadi kwatha in the management of Pcos |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHATAPUSHPA KALPA AND VARUNADI KWATHA IN THE MANAGEMENT OF PCOS |
| 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 Gargi Pathak |
| Designation |
MS PG Scholar |
| Affiliation |
Jeevan jyoti Jeevan Jyoti Ayurvedic Medical College and Hospital |
| Address |
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
8368212252 |
| Fax |
|
| Email |
gargipathak0709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamata Kumari swain |
| Designation |
MD PhD Ayurveda HOD Department of Prasutitantra Evum Stree Riga |
| Affiliation |
Jeevan Jyoti Ayurvedic Medical College and Hospital |
| Address |
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
9348576189 |
| Fax |
|
| Email |
swaindrmamata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamata Kumari swain |
| Designation |
MD PhD Ayurveda HOD Department of Prasutitantra Evum Stree Riga |
| Affiliation |
Jeevan Jyoti Ayurvedic Medical College and Hospital |
| Address |
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Aligarh
UTTAR PRADESH
202140
India |
| Phone |
9348576189 |
| Fax |
|
| Email |
swaindrmamata@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jeevan Jyoti Ayurvedic Medical college and hospital |
| Address |
Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha Uttar Pradesh 202140 |
| 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 |
| Gargi Pathak |
Jeevan jyoti ayurvedic medical college and hospital |
Department of pg studies in prasuti tantra evam stree roga Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh Palwal Rd Lodha
Aligarh
UTTAR PRADESH |
8368212252
05712213536
gargipathak0709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa kalpa , Reference: Kashyap samhita kalpa sthana chapter 5, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -shatpushpa | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwatha , Reference: Sushruta samhita sutra sthana chapter 38 shlok 89 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients in between 18 and 40 years of age
Patients with sign and symptoms of oligomenorrhea amenorrhea obesity and hirusitsm due to PCOS
Clinically diagnosed patient based on USG i.e number of follicles and ovarian volume |
|
| ExclusionCriteria |
| Details |
patient with hypothyroidism primary ovarian failure
patient with hyperprolactinemia
patient with congenital anomalies of reproductive system
patients having any other systemic disorder |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To regulate the irregular menstrual cycle of the patient |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of varunadi kwatha in pcos |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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)
|
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
|
PCOS is the most common syndrome of young females. Because of modern lifestyle and diet changes, females having more problems related to menstruation So, here in this study , I’m going to use two form of medications in 40 patients divided inyo two groups. The first group will be given shatapushpa kalpa and the second group will be given varunadi kwatha and the end result of both will be compared and evaluated. |