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CTRI Number  CTRI/2026/01/100757 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative clinical trial to evaluate the efficacy of shatapushpa churna and shatapushpa taila nasya in artava dushti w.s.r. to poly cystic ovarian syndrome. 
Scientific Title of Study   Randomized comparative clinical trial to evaluate the efficacy of shatapushpa churna along with shatapushpa taila nasya in artava dushti w.s.r. to poly cystic ovarian syndrome (PCOS) 
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 Narendra Kumar Meena 
Designation  PhD Scholar 
Affiliation  Post Graduate Institute of Ayurveda PGIA Jodhpur Rajathan India 342037 
Address  PG department of Prasuti Tantra and Stri Roga Post Graduate Institute of Ayurveda PGIA Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9950129673  
Fax    
Email  narendermeena42@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Prof Rajesh Kumar Gupta 
Designation  HOD and Guide  
Affiliation  Post Graduate Institute of Ayurveda PGIA Jodhpur Rajathan India 342037 
Address  PG department of Shalya Tantra Post Graduate Institute of Ayurveda PGIA Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Rajesh Kumar Gupta 
Designation  HOD and Guide  
Affiliation  Post Graduate Institute of Ayurveda PGIA Jodhpur Rajathan India 342037 
Address  PG department of Shalya Tantra Post Graduate Institute of Ayurveda PGIA Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt Ayurveda College Udaipur Rajasthan 313001 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurveda College Udaipur 
Address  Madan Mohan Malviya Govt Ayurveda College Udaipur Rajasthan 313001 
Type of Sponsor  Government medical college 
 
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 Narendra Kumar Meena  Madan Mohan Malviya Government Ayurveda College And Hospitals, Udaipur  OPD no. 05, Rajkiya Vaidya Prem Shankar Sharma Ayurved Chikitsalaya Ambamata, Udaipur
Udaipur
RAJASTHAN 		 9950129673

mnarendrakumar430@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Madan Mohan Malviya Government Ayurveda College Udaipur Rajasthan  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
1Comparator Arm (Non Ayurveda)-MALA-NNorethisterone 1 milligram Ethinylestradiol 30 micrograms 1 Tab daily for 21 days every Month for 3 months.
2Intervention ArmDrugClassical(1) Medicine Name: Shatapushpa Churna, Reference: Kashyap Samhita, Kalpa Sthan, Chapter 5/5-6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: - Shatapushpa Taila (Ka. S., Kalpa Sthan, Chapter 5/14), Nasya, 8 drops, OD, Abhakta for 3 months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. If Patient willing to give informed consent to be included.
2. Female patient of age group between 18 - 40 years (both married and unmarried).
3. ASRM or ESHRM (Rotterdam) criteria
Affected patient must follow two out of three criteria
(1) Anovulation,
(2) Hyperandrogenism (clinical/biochemical),
(3) Polycystic Ovaries (confirmed by USG). 
 
ExclusionCriteria 
Details  • Patient who is not willing to give voluntary informed consent.
• Women of age less than 18 years and more than 40 years.
• Patient with chronic systemic illness (cardiac failure, hypertension, diabetes mellitus, tuberculosis, chronic renal disease).
• Patient with carcinoma of reproductive organs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To explore the effectiveness of Shatapushpa churna along with Shatpushpa taila nasya in the management
of Artava Dushti w.s.r to Polycystic ovarian syndrome (PCOS) and compare with modern medicine. 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the efficacy of the interventions on LH, FSH levels in the management of polycystic
ovarian syndrome (PCOS).
2. To determine the efficacy of interventions on changes in size & volume of ovary in Polycystic ovarian
syndrome (PCOS) 		 90 days 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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 2 
Date of First Enrollment (India)   25/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study is to evaluate the effect of oral administration Shatapushpa Churna along with Shatapushpa taila nasya and to compare it with the effect of oral contraceptive pills containing Norethisterone and Ethinylestradiol in Artavadusti w. s. r. to Poly Cystic Ovarian Syndrome. it is a randomized, open-labeled, comparative clinical trial conducted for 90 days with a follow-up of 30 days. It includes 94 female patients aged 18 to 40 years diagnosed with PCOS based on Rotterdam criteria. Participants are divided into two groups — one receiving Shatapushpa Churna with Shatapushpa Taila Nasya and the other receiving oral contraceptive pills containing Norethisterone and Ethinylestradiol. The main objective is to assess improvement and possible cure of PCOS and related menstrual irregularities (Artava Dushti). Secondary observations include changes in acne, hirsutism, hormone levels (LH, FSH, and testosterone), and ovarian size on ultrasonography. Assessment will be done through menstrual history, acne and hirsutism scoring, hormonal evaluation, and pelvic USG. The study aims to compare the efficacy of Ayurvedic treatment with standard hormonal therapy in managing PCOS. 
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