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CTRI Number  CTRI/2021/02/031599 [Registered on: 26/02/2021] Trial Registered Prospectively
Last Modified On: 24/02/2021
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   Effect of medicated enema and ayurvedic medicine on PCOS 
Scientific Title of Study   Clinical study to evaluate the efficacy of combination shatapushpa taila matra basti and rajahpravartini vati in comparison to rajahpravartini alone in artava kshaya (PCOS). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MEGHA NAUTIYAL 
Designation  MD SCHOLAR (DEPARTMENT OF PANCHKARMA) 
Affiliation  CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Room No. 238 second floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
Room No. 238 first floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
South West
DELHI
110073
India 
Phone  9548439670  
Fax    
Email  meghanautiyal786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF DR ARUN GUPTA 
Designation  HEAD OF DEPARTMENT (PANCHKARMA) 
Affiliation  CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Room No 142 first floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
Room No 142 first floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
South West
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  ARUN24@HOTMAIL.COM  
 
Details of Contact Person
Public Query  
Name  MEGHA NAUTIYAL 
Designation  MD SCHOLAR (DEPARTMENT OF PANCHKARMA 
Affiliation  CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  Room No 238 second floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
Room No 238 second floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West DELHI
South West
DELHI
110073
India 
Phone  9548439670  
Fax    
Email  meghanautiyal786@gmail.com  
 
Source of Monetary or Material Support  
Ch Brahm Prakash Ayurved Charak Sansthan 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NEW DELHI 
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 
Megha Nautiyal  Ch. Brahm Prakash Ayurved Charak Sansthan  Panchkarma Therapy Section Room No-238 Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh South West Delhi
South West
DELHI 		 9548439670

Meghanautiyal786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, CBPACS  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: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patients will be given 2 sittings of Shatapushpa Taila Matra Basti(60ml) for 8 days, for 2 months (one sitting each month) along with oral Rajahpravartini Vati (250mg, TDS) for 2 months.   Patients will be given 2 sittings of Shatapushpa Taila Matra Basti(60ml) for 8 days, for 2 months (one sitting each month) along with oral Rajahpravartini Vati (250mg, TDS)for 2 months.  
Comparator Agent  patients will be given drug Rajahpravartini Vati(250mg, TDS) for 2 months orally.   patients will be given drug Rajahpravartini Vati(250mg, TDS) for 2 months orally.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patient willing to go through trial.
• Patient prediagnosed with PCOS.
• Patients suffering from at least 2 consecutive cycles with Oligomenorrhoea and/ or anovulation.
• Affected individuals presented with two out of three criteria of ASHRM/ESHRE (ROTTERDAM) CRITERIA 2003
1. Oligo or anovulation
2. Hyperandrogenism clinical or biochemical 3. Polycystic ovaries on sonographic examination 
 
ExclusionCriteria 
Details  Patient diagnosed with chronic systemic illness.
• Patient diagnosed with reproductive system congenital abnormalities.
• Patient diagnosed with any type of malignancy.
• Pregnancy and lactation.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in symptoms of Artava Kshaya  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in symptoms of PCOS.   90 days 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/03/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is conducted to compare the efficacy of combination of Shatapushpa Taila Matra Basti and Rajahpravartini Vati in management of Artava Kshaya (PCOS) with Rajahpravartini Vati alone.  In GROUP A 17 Patients will be given 2 sittings of Shatapushpa Taila Matra Basti for 8 days, for 2 months (one sitting each month) along with oral Rajahpravartini Vati for 2 months. In GROUP B 17 patients will be given drug Rajahpravartini Vati for 2 months orally.  Study will be conducted in CBPACS with outcome in relief in symptoms of Artava kshaya and PCOS. After 90 days follow up of each patient will be taken. This study is expected to improve female reproductive health.  
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