| CTRI Number |
CTRI/2025/02/081328 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Rasapachak vati and Sahacharadi Tail Basti and Oral contraceptive pills and Metformin in PCOD patients |
|
Scientific Title of Study
|
Evaluation of comparative Efficacy of combination of Rasapachak Vati with Sahacharadi tail Basti versus Oral contraceptive pills along With Metformin on ovarian Morphology in patients of Polycystic ovarian syndrome -A Randomised Control Trial |
| 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 Vidya Bhaskarrao Dole |
| Designation |
Assistant Professor |
| Affiliation |
Govt Ayurved College, Vajirabad |
| Address |
Department of Rachana Sharir,Govt Ayurved College
Vajirabad, Nanded.
Department of Stri-roga and Prasuti Tantra, OPD No. 13, Govt Ayurved College
Vajirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
07083434569 |
| Fax |
|
| Email |
drvidyadole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sawarkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre, |
| Address |
Department of Rachana Sharir, Mahatma Gandhi Ayurved College Hospital and Research Centre,Salod(H), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9970082590 |
| Fax |
|
| Email |
drsawarkar.gaurav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sawarkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre, |
| Address |
Department of Rachana Sharir, Mahatma Gandhi Ayurved College Hospital and Research Centre,Salod(H), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9970082590 |
| Fax |
|
| Email |
drsawarkar.gaurav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Striroga and Prasuti Tantra, OPD No.13, Government Ayurved College, Nanded, Maharashtra- 431601, India |
|
|
Primary Sponsor
|
| Name |
Dr Vidya Bhaskarrao Dole |
| Address |
Department of Rachana Sharir, Govt. Ayurved College, & Hospital Vajirabad Nanded, Maharashtra -431601, India |
| Type of Sponsor |
Other [] |
|
|
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 Vidya Dole |
Govt. Ayurved College And Hospital, |
Department of Stri-roga and Prasuti Tantra, OPD No.13, Govt. Ayurved College and Hospital, Nanded
Vajirabad.
Nanded
MAHARASHTRA |
07083434569
drvidyadole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Govt Ayurved College Nanded |
Approved |
| Mahatma Gandhi Ayurved College, Hospital and Research centre, Salod (H), Wardha, Maharashtra-442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N832||Other and unspecified ovarian cysts. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasapachak Vati, Reference: Ch. Chi. 3/200, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling the Rotterdam 2003 criteria for diagnosis. |
|
| ExclusionCriteria |
| Details |
- Patient suffering from gynecological disorder other than PCOS.
- History of hypersensitivity to OC Pills.
- Patient suffering from any systemic chronic illness.
- Patients on hormonal therapy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of cysts in ovary, Ovarian size & volume, Anthropometric parameters will be reduced. |
Reduction in Number of cysts, Ovarian size & volume, Anthropometric parameters will be assessed at 0th day and 120th day of follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To understand the changes in ovarian morphology through Ayurveda point of view.
2)To record the adverse effect of the treatment if any. |
During first two weeks. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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="3"
Months="10"
Days="15" |
|
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
|
Both experimental and control groups are studied, respectively, and observations and conclusions are drawn from statistical tests for significance. |