| CTRI Number |
CTRI/2025/08/093007 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Tab Pcosta With Tab PCOS Herb In Aartavkshay(Polycystic Ovarian Syndrome) |
|
Scientific Title of Study
|
Open Randomised Control Clinical Trial Of Tab Pcosta (Formulation Of Tamrabhasma With Nirgundi Beejchurna,Kumari Ghanasar,Shunthi Churna,Dalchinichurna) With Tab PCOS Herb(Formulation Of Nirgundi Beejchurna Churna,Kumari Ghanasar,Shunthi Churna,Dalchini Churna) In Aartavkshay With Special Reference To Polycystic Ovarian Syndrome |
| 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 Bhagyashree Babasaheb Pawar |
| Designation |
PG Scholer |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta |
| Address |
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Dhanvantari Ayurved Hospital OPD 6 Strirog And Prasuti Tantra OPD Ground Floor Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9309144426 |
| Fax |
|
| Email |
pawarbhagyashree32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta Tal Walwa
Department Of Strirog And Prasuti Tantra 3rd floor Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research centre Ashta Tal walva
Research Center Ashta walva Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research centre Ashta Tal Walva
Department Of Strirog And Prasuti Tantra 3rd Floor Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research centre Ashta Tal walva
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta
Tal-Walwa Dist-Sangli Maharashtra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashree Babasaheb Pawar |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurvedic Hospital Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research centre Ashta Tal Walwa Dist Sangli Pincode 416301 State Maharashtra country India |
| 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 Bhagyashree Babasaheb Pawar |
Hon Shri Annasaheb Dange Ayurved Medical College & Research Center Ashta |
OPD No 6 Strirog And Prasuti Tantra Department Dhanwantari Ayurvedic Hospital Ashta Tal Walwa Dist Sangli Maharashtra
India Pincode 416301
Sangli
MAHARASHTRA |
9309144426
pawarbhagyashree32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (1) Medicine Name: Tab Ovral L , Reference: Pharmacology , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: -koshna jal ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tab Picosta with Tab PCOS Herb, Reference: Rasatarangini, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient of age group 18-35 years irrespective of marital status.
2. .known cases of PCOS.
3. Patient fulfilling:-Rotterdam criteria:-(ESHRE/ASRM 2003) requires
any of two of the following three criteria for the diagnosis of PCOS.
Oligomenorrhoea or amenorrhoea
Hyperandrogenism-clinical and biochemical.
USG suggestive of.— |
|
| ExclusionCriteria |
| Details |
1 Patient diagnose with Fibroid Adenomyosis Endometriosis
2 Anemia:HB less than 7mg Diabetes Mellitus
3 Lactating mother
4 Pittapradhan Prakruti
5 Pregnant women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regimen of Tab P-COSTA with Tab P-COS HERB is effective in Aartavkshay |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tab Ovral-L (OC pills) is more effective in Aartavkshay |
180 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/09/2025 |
| 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 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
|
In this modern era the sedentary life faulty food habits stress lack of physical exercise etc affects the health of a woman Ultimately it leads to menstrual abnormalities In last two decades women are suffering more commonly from hormonal imbalance which is leading to menstrual abnormalities Among these PCOS has become the serious condition which is affecting women reproductive health Polycystic ovary syndrome is a complex condition characterized by elevated Androgen levels menstrual irregularities and small cysts on one or both ovaries PCOS can be correlated with Aartavkshay symptoms of Aartavkshay has given in sushrutsamhita This indicates irregular prolonged intermenstrual period menstrual blood alpata and pain in yoni vedana In modern science Aartarkshay can be correlated to oligomenorrhea: or Hypomenorrheaoligo hypomenorrhea is an absolute symptoms PCOS is an endocrine polygenic multifactorial metabolic syndrome leading to irregular prolonged scanty menstrual pattern PC0S is not directly mentioned in Ayurvedic Samhita but evidence describing its symptoms Present in Kashyap samhita In India prevalence rate of PCOS is 36 percent PCOS is burning issue nowadays as many of population of reproductive age are suffering from the disease due to unhealthy lifestyle In modern medical science combined OC pills is the main choice of treatment for the disease but its long term use invites positive results with many side effects and relapse of disease after its withdrawal Keeping this in mind intervention of Ayurvedic drug is essential |