| CTRI Number |
CTRI/2025/08/092263 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Effect of Ashwagandha, Gokshura, and Daruharidra Herbal Powder in Women with Irregular Periods and PCOS, Focusing on Hormone Balance and Insulin Resistance |
|
Scientific Title of Study
|
A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Ashwagandha, Gokshura and Daruharidra Churna orally in Artava Kshaya with special reference to LH: FSH ratio and Insulin Resistance in 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 Rajani Kagga |
| Designation |
PhD Scholar |
| Affiliation |
Yaswant Ayurvedic College, Post Graduate Training & Research, Kodoli |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishala Turlapati |
| Designation |
Professor & HOD, Guide |
| Affiliation |
Yaswant Ayurvedic College, Post Graduate Training & Research, Kodoli, Maharastra University of Health Sciences, Nashik |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Kagga |
| Designation |
PhD Scholar |
| Affiliation |
Yaswant Ayurvedic College, Post Graduate Training & Research, Kodoli |
| Address |
Department of Prasuti Tantra Evum Stree Roga , Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114 |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114 |
| Type of Sponsor |
Private medical college |
|
|
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 Rajani Kagga |
Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli |
Department of Prasuti Tantra Evum Stree Roga, Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli
Tal. Panhala, Dist. Kolhapur – 416114
Kolhapur
MAHARASHTRA |
9739766448
drcrajanii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic College Post Graduate Training & Research Centre, Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N925||Other specified irregular menstruation. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha Gokshura Daruharidra, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin Hydrochloride | 250mg , twice a day after food for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a.Patients between the age group of 18 years to 35 years, irrespective of marital status.
b.Patients fulfilling Rotterdam criteria.
c.Patients presenting with any of the classical features of Artava Kshaya, Nashtarthava, Pushpaghni, Vikuta Jataharini.
d.Patients willing to sign consent form.
|
|
| ExclusionCriteria |
| Details |
a.Patients with Primary Amenorrhea.
b.Patients with known case of Premature Ovarian Failure.
c.Patients using of Oral Contraceptives (current or within the last 3 months).
d.Patients with Known case of Malignancies and Chronic Systemic Diseases and Psychiatric disorders.
e.Patients with Known case of Adrenal Hyperplasia, AndrogenSecreting Neoplasm, Cushing Syndrome. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To evaluate the efficacy of Ashwagandha, Gokshura and Daruharidra Churna orally in Artava Kshaya with special reference to LH: FSH ratio and Insulin Resistance in Polycystic Ovarian Syndrome. |
Day0 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To observe the combined effect of Ashwagandha, Gokshura, and Daruharidra Churna on LH: FSH ratio and Insulin Resistance in women diagnosed with Artava Kshaya with special reference to Polycystic Ovarian Syndrome against standard control Metformin Hydrochloride.
• To measure effect of Ashwagandha, Gokshura and Daruharidra on LH: FSH ratio by analyzing Baseline Serum LH, FSH ratio and Insulin Resistance by , Fasting Glucose/Insulin Ratio and Acanthosis Nigricans scoring chart before and after the treatment.
• To achieve reduction in LH: FSH ratio and Insulin resistance when given for 3 menstrual cycles
|
Day0 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
30/08/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
|
This randomized, open-labelled controlled clinical study is designed to evaluate the efficacy of a polyherbal formulation comprising Ashwagandha (Withania somnifera), Gokshura (Tribulus terrestris), and Daruharidra (Berberis aristata) Churna administered orally in patients diagnosed with Artava Kshaya, with special reference to LH:FSH ratio and insulin resistance in Polycystic Ovarian Syndrome (PCOS). Artava Kshaya, as described in Ayurveda, is characterized by menstrual irregularities, scanty bleeding, and associated symptoms, which closely resemble the clinical manifestations of PCOS. The selected herbs have documented actions in Ayurveda and modern research, including hormonal modulation, anti-inflammatory effects, and insulin-sensitizing properties. A total of 112 female participants (aged 18–35 years) fulfilling Rotterdam criteria for PCOS and Ayurvedic signs of Artava Kshaya will be randomized into two groups: -
Group A (Trial Group): Will receive 3g of Ashwagandha, Gokshura, and Daruharidra Churna orally, twice daily on an empty stomach for 3 menstrual cycles. -
Group B (Control Group): Will receive 250 mg of Metformin Hydrochloride twice daily after food for 3 menstrual cycles. Both groups will follow a standardized low-calorie diet and daily exercise regimen. Efficacy will be assessed based on changes in LH:FSH ratio, fasting glucose/insulin ratio , menstrual patterns, anthropometric indices (BMI, WHR), and USG-based ovarian morphology. Subjective symptoms and signs rooted in Ayurvedic diagnostics will also be tracked using predefined grading scales. This study aims to bridge a significant knowledge gap by evaluating a safe, cost-effective, and holistic Ayurvedic alternative to conventional therapy for PCOS and Artava Kshaya, while contributing to evidence-based integration of traditional medicine. |