| CTRI Number |
CTRI/2025/07/091322 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Integrated Management of PCOS: A Triple-Arm Study Combining Modern, Ayurvedic, and Homeopathic Treatments |
|
Scientific Title of Study
|
EFFECT OF INTEGRATED LINE OF TREATMENT IN THE MANAGEMENT OF PCOS WITH SPECIAL REFERENCE TO MODERN MEDICINE AYURVED and HOMOEOPATHY A TRIPLE ARM RANDOMIZED OPEN LABELLED PILOT CLINICAL STUDY |
| 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 Deepti Sharma |
| Designation |
Professor |
| Affiliation |
Parul institute of Medical Sciences and Research |
| Address |
5, NILAMBAR TOWNSHIP, NR. PARNAKUTIR,
Limda, waghodia,
Vadodara
GUJARAT
390019
India |
| Phone |
9898317180 |
| Fax |
|
| Email |
deepti.sharma20129@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Patel |
| Designation |
Vice president |
| Affiliation |
PIMSR |
| Address |
Parul university, Limda, Waghodia
LIMDA, WAGHODIA
Vadodara
GUJARAT
391760
India |
| Phone |
9825469544 |
| Fax |
|
| Email |
vicepresident_31@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Mathad |
| Designation |
Professor |
| Affiliation |
PIAR |
| Address |
PIAR, Parul university, Limda, Waghodia
Parul Institute of Ayurved and research, Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
9448630285 |
| Fax |
|
| Email |
prasanna.mathad86177@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Research and Development cell Parul University,Limda, Waghodia, Vadodara, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
RESEARCH ND DEVELOPMENT CELL PARUL UNIVERSITY |
| Address |
Parul University
Limda , waghodia
Vadodara, India
391760
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 deepti Sharma |
Parul Sevashram Hospital |
Obstetrics & Gynecology department, PIMSR, Limda, Waghodia
Vadodara
GUJARAT |
9898317180
deepti.sharma20129@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional ethics commettee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E28||Ovarian dysfunction. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saptasara kashaya, Reference: Sahasra yoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -NA(2) Medicine Name: Rajapravrtini vati, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -wter), Additional Information: -NA | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Metformin, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Patient willing to give written consent
raised GTT
irregular menstruation
hirsutism |
|
| ExclusionCriteria |
| Details |
congenital anomalies
known case of Infectious diseases |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
regular menstruations after 3 months
reduction in weight after 6 months
quality improvement of life after 6 months |
at 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proper ovulatory cycle
Quality improvement |
6month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
31/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Polycystic Ovary Syndrome (PCOS) affects adolescents and women of reproductive age by causing hormonal imbalances, leading to irregular menstruation, anovulation, and potential fertility issues. Later in life, it can cause metabolic abnormalities such as hyperinsulinemia and cardiovascular diseases. Early diagnosis and treatment can mitigate these conditions to some extent. Modern medical treatments for PCOS revolves around hormonal imbalance responsible for the condition. Options include hormonal drugs depending on presenting symptoms. Hormone derived side effects are unavoidable in some patients due to which some of the treatments that can help improve the condition without having major side effects can be employed. Therefore, it would be helpful to develop medications that balance hormones, promote weight reduction, and have fewer toxic effects on the body. Thus, this study aims to manage PCOS using complementary alternative system like Ayurved and Homoeopathy along with Modern medical management that are believed to have fewer toxic effects and greater potential. Hence, there is significant scope for research to discover safe and effective remedies by integrating Modern medical treatment in conjunction with Ayurved and Homoeopathy for the management of PCOS. |