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CTRI Number  CTRI/2021/04/032523 [Registered on: 05/04/2021] Trial Registered Prospectively
Last Modified On: 01/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to find the effect of Takra basti for duration of 8 days along with panchamruta parpati in the management of irritable bowel syndrome (I.B.S.) 
Scientific Title of Study   Clinical study on the effect of Takra basti as yoga basti with panchamruta parpati in the management of irritable bowel syndrome (I.B.S.) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  mamata nakade  
Designation  Professor and HOD  
Affiliation  d y patil college of ayurved and research centre pimpri pune 
Address  OPD NO.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune
OPD NO.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune
Pune
MAHARASHTRA
411018
India 
Phone  9850241887  
Fax    
Email  mamta.nakade@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  mamata nakade  
Designation  Professor and HOD  
Affiliation  d y patil college of ayurved and research centre pimpri pune 
Address  OPD No.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune 18
OPD No.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India 
Phone  9850241887  
Fax    
Email  mamta.nakade@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  mamata nakade  
Designation  Professor and HOD  
Affiliation  d y patil college of ayurved and research centre pimpri pune 
Address  OPD No.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune 18
OPD No.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune 18
Pune
MAHARASHTRA
411018
India 
Phone  9850241887  
Fax    
Email  mamta.nakade@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil college of ayurved and research centre pimpri pune 
 
Primary Sponsor  
Name  dr d y patil patil vidyapeeth pune 
Address  sant tukaram nagar pimpri pune 
Type of Sponsor  Research institution and hospital 
 
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 mamata nakade  dr d y patil vidyapeeth pune  OPD No.9 Department of Panchakarma D Y Patil college of Ayurved and Research centre Pimpri Pune 18
Pune
MAHARASHTRA 		 9850241887

mamta.nakade@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 18 Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Panchamrutparpati and takrarishta  Panchamrutparpat 250 mg Bid and Takrabasti as Yoga Basti with Masur Ghrita as Matra Basti For 7 days duration 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients with irritable bowel syndrome 
 
ExclusionCriteria 
Details  patients suffering from any other systemic disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relieving signs and symptoms of Irritable Bowel Syndrome  before start of trial and end of trial i.e. on 1st day and 8th day of trial 
 
Secondary Outcome  
Outcome  TimePoints 
standardized the Takra Basti procedure   at start of trial and end of trial i.e. on 1st day and 8th day of trial 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   08/04/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no publication 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included mamta.nakade@dpu.edu.in).

  6. For how long will this data be available start date provided 30-12-2020 and end date provided 15-12-2025?
    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   30 patients will be taken for clinical trial 
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