| CTRI Number |
CTRI/2026/01/102438 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of an Ayurvedic Combination Therapy (Vyoshadi Guggulu and Kathakakhadiradi Pana) on Insulin Resistance in Women with Polycystic Ovary Syndrome |
|
Scientific Title of Study
|
Combined effect of Vyoshadi Guggulu tablet with Kathakakhadiradi Pana on insulin resistance in Polycystic Ovarian Syndrome (PCOS)- a single arm clinical 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 |
RAKHI RAVEENDRAN |
| Designation |
PG Scholar, Dept of Prasutitantra and Striroga |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College and Hospital
Pulimoodu junction Thiruvananthapuram
Kerala
Dept of Prasuti tantra and Stree roga ROOM NO:1
Thiruvananthapuram KERALA 695001 India |
| Phone |
9778033340 |
| Fax |
|
| Email |
rakhi.ravindran88@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
RAKHI RAVEENDRAN |
| Designation |
PG Scholar, Dept of Prasutitantra and Striroga |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College and Hospital
Pulimoodu junction Thiruvananthapuram
Kerala
Dept of Prasuti tantra and Stree roga ROOM NO:1
Thiruvananthapuram KERALA 695001 India |
| Phone |
9778033340 |
| Fax |
|
| Email |
rakhi.ravindran88@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Maya Balakrishnan |
| Designation |
Professor and HOD, Dept of Prasutitantra and Striroga |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College and Hospital
Pulimoodu junction Thiruvananthapuram
Kerala
Dept of Prasuti tantra and Stree roga ROOM NO:1
Thiruvananthapuram KERALA 695001 India |
| Phone |
9961475750 |
| Fax |
|
| Email |
bittysunil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College Hospital
Pulimoodu Junction
Thiruvananthapuram
695001
Kerala
India |
|
|
Primary Sponsor
|
| Name |
RAKHI RAVINDRAN |
| Address |
Government Ayurveda Medical College Hospital
Pulimoodu Junction Thiruvananthapuram
695001
Kerala
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 Rakhi Ravindran |
Government Ayurveda Hospital for Women and Children |
Department of Prasuti Tantra and Stree Roga, OP NO 1, Thiruvananthapuram, Kerala Thiruvananthapuram KERALA |
9778033340
rakhi.ravindran88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College, Thiruvananthapuram, Kerala, India |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kathakakhadiradi Pana, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -(2) Medicine Name: Vyoshadi guggulu, Reference: Ashtanga Hridaya Chikitsa Sthana, Route: Oral, Dosage Form: Guggulu , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 20 to 35 years diagnosed with PCOS based on Rotterdam criteria 2018, with BMI between 25 and
34.9 and HOMA IR above 1 |
|
| ExclusionCriteria |
| Details |
Uncontrolled systemic illness
Diagnosed cases of Cushing’s syndrome, Androgen secreting tumors, Hyperprolactinemia
Known case of malignancy
Known case of diabetes
Pregnant or lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in HOMA-IR |
0th day, 91st day and 121st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in BMI
Changes in Waist hip ratio
Changes in intervals of consecutive menstrual bleeding
Changes in lipid profile |
0th day, 91st day and 121st day |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="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
|
Polycystic Ovarian Syndrome is a multifactorial disorder marked by chronic anovulation, hyperandrogenism, and polycystic ovaries, affecting approximately 1 in 10 women globally. Its prevalence varies depending on diagnostic criteria, with estimates ranging from 6 to13 percent, and up to 70 percent of cases remaining undiagnosed. Comorbidities commonly associated with PCOS include metabolic syndrome, obesity, infertility, impaired glucose tolerance, cardiovascular risk, depression, obstructive sleep apnea, and endometrial cancer. PCOS is often genetically predisposed and exacerbated by obesity. Weight gain in such individuals can lead to clinical and biochemical manifestations of the condition. Conversely, modest weight loss, around 5 percent has been shown to significantly improve reproductive, hyperandrogenic, and metabolic features. Despite its high prevalence, there is no universally accepted treatment protocol for PCOS. The condition is complex due to its heterogeneous presentation and overlap with obesity related metabolic dysfunctions. In Ayurveda, PCOS is considered a Vyadhi Sankara, with symptoms varying in severity and presentation across different life stages. It resembles Pushpagni Jathaharini, characterized by anovulatory cycles, excess body hair, and menstrual disturbances. It may also align with Nashtartava, where obstruction in the Artavavaha Srotas, mainly due to Kapha predominance, is seen as a root cause. In the present study, 20 female participants aged 20 to 35 years, attending the OPD and diagnosed with PCOS with insulin resistance HOMA IR above 1 and BMI between 25 to 34.9, will be selected. They will be administered Vyoshadi Guggulu, 2 tablets twice daily before food and KathakaKhadiradi Pana, 100 ml twice daily half an hour before food for 90 days. Outcome measures including insulin resistance, BMI, waist hip ratio, lipid profile, and menstrual interval will be assessed before and after treatment. Data will be analyzed statistically. |