| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: YONIR, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: | | 2 | Intervention Arm | Drug | Classical | | (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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- 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.
- 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.
- 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. |