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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.
 
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