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CTRI Number  CTRI/2025/11/096845 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study on Shatapushpa and Patadee Powders in the Ayurveda Management of PCOS 
Scientific Title of Study   A Comparative Study Of Shatapushpa powder and Patadee powder in the management of Granthibhoota Artava dushti W.S.R. 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  K H P Ranathunga 
Designation  Medical Officer 
Affiliation  Bandaranayake Memorial Ayurveda Research Institute 
Address  Bandaranayake Memorial Ayurveda Research Institute, Unit Of Sthreeroga Prasuti Tantra Room 04 Old Kottawa Road Maharagama Sri Lanka
Bandaranayake Memorial Ayurveda Research Institute, Unit Of Sthreeroga Prasuti Tantra Room 04 Old Kottawa Road Maharagama Sri Lanka


10280
Other 
Phone  0094775103858  
Fax    
Email  hansipranathunga@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  H L M G Sajeewani 
Designation  Consultant 
Affiliation  Bandaranayake Memorial Ayurveda Research Institute 
Address  Bandaranayake Memorial Ayurveda Research Institute, HOD, Unit Of Shreeroga Prasuti Tantra, Room 04 Old Kottawa Road Maharagama Sri Lanka
Bandaranayake Memorial Ayurveda Research Institute, HOD, Unit Of Shreeroga Prasuti Tantra, Room 04 Old Kottawa Road Maharagama Sri Lanka


10280
Other 
Phone  0094718047368  
Fax    
Email  sabinaurs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  HLMG SAJEEWANI 
Designation  Consultant 
Affiliation  Bandaranayake Memorial Ayurveda Research Institute 
Address  Bandaranayake Memorial Ayurveda Research Institute, HOD, Unit Of Shreeroga Prasuti Tantra, Room 04 Old Kottawa Road Maharagama Sri Lanka
Bandaranayake Memorial Ayurveda Research Institute, HOD, Unit Of Shreeroga Prasuti Tantra, Room 04 Old Kottawa Road Maharagama Sri Lanka


10280
Other 
Phone  0094718047368  
Fax    
Email  sabinaurs@gmail.com  
 
Source of Monetary or Material Support  
Bandaranayake Memorial Ayurveda Research Institute, Room o4, Sthree Roga Prasuti Unit, Old Kottawa Road Maharagama,10280 Sri Lanka 
 
Primary Sponsor  
Name  Bandaranayake Memorial Ayurveda Research Institute 
Address  Bandaranayake Memorial Ayurveda Research Institute, HOD, Unit Of Shreeroga Prasuti Tantra, Room 04 Old Kottawa Road Maharagama-10280 Sri Lanka 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Sri Lanka  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KHP Ranathunga  Bandaranayake Memorial Ayurveda Research Institute  Bandaranayake Memorial Ayurveda Research Institute, Room 04,Sthree Roga Prasuti Tantra Unit, Old Kottawa Road, Nawinna, Maharagama, Sri Lanka

 
0094775103858

hansipranathunga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
REC BMARI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: YONIR,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shatapushpa Choorna, Reference: Kashyapa Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Hot Water), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Shatapushpa Choorna, Reference: Susruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Hot water), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  I. Married/ Unmarried Women aged 18-35 years
II. Diagnosed with PCOS based on Rotterdam criteria (2 out of 3 symptoms if present)
 
 
ExclusionCriteria 
Details  I. Patients below 18 years and above 35 years.
II. Intake of any testosterone level modifying drugs in the 3 months prior to study inclusion.
III. Female participants who are ovariectomized, hysterectomized or post-menopausal
IV. Pregnant or lactating women
V. Potentially severe immunosuppression or intake of other immunosuppressive drugs
VI. Other clinically significant concomitant disease states (e.g., renal failure, active carcinoma), and women with other endocrine disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of the clinical outcomes of PCOS with improving menstrual regularity.  12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in free testosterone level.
Improvement in Ovarian Volume.
Improvement in weight evidence by BMI & improvement in body fat distribution by waist circumference (WC) hip circumference (HC) & waist/hip ratio.
 
12 WEEKS 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="0" 
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/ Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  By sending request email and data requestors will need to sign a data access agreement.

  6. For how long will this data be available start date provided 06-11-2025 and end date provided 06-11-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Pathadi Yoga said in the context of Granthiboota arthavadushti , is an effective drug  to be used in PCOS. The Deepana and Pachana properties of Trikatu, Kutaja, and Patha are well-documented in Ayurveda for their role in stimulating the digestive fire (Agni) and promoting effective digestion and metabolism,   Properties of Shatakuppa make it highly beneficial in balancing Vata and Kapha doshas. Shatpushpa (Anethum sowa) exhibits multiple pharmacological actions that align with its traditional Ayurveda uses in managing metabolic, digestive, and reproductive health issues. According to Kashyapa Samhita Artava (Ovam) has having Agney (Hot) property Shathapushpa is with Katu Rasa and Ushna Virya can be used for the purpose formation of Stree Beeja (Ovulation). And Shatapushpa, promoter of digestive fire (Agni Vardhani), has properties that initiate menstruation(Ritu Pravartani).

The bioactive compounds associated with Shatpushpa, improve digestive and metabolic processes and support reproductive health by promoting tissue nourishment and regulating menstrual flow.

By comparing Shatapushpa Powder with Patadee Powder, the study seeks not only to confirm Shatapushpa’s efficacy in a controlled clinical setting but also to investigate whether Patadee Powder offers comparable or enhanced therapeutic benefits. Given that Shatapushpa is already standard in Ayurveda practice for Granthibhoota artavadushti, this study could also help standardize the use of these powders by providing clinical evidence of their efficacy, safety, and potential benefits over one another.

 
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