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CTRI Number  CTRI/2025/03/081889 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of selected Ayurvedic treatment Virechana (purgation therapy) in Irritable Bowel Syndrome 
Scientific Title of Study   EFFECT OF SELECTED AYURVEDIC TREATMENT PROTOCOL IN IRRITABLE BOWEL SYNDROME  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lakshmi Narayan Gouda  
Designation  First Year P G scholar  
Affiliation  Govt Ayurveda college Thiruvananthapuram  
Address  Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram Kerala - 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  6361003207  
Fax    
Email  lakshmingouda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Ambika  
Designation  Professor and HOD  
Affiliation  Government Ayurveda college Thiruvananthapuram  
Address  Professor and HOD Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram Kerala - 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9847457084  
Fax    
Email  ambikachitharanjan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Ambika 
Designation  Professor and HOD 
Affiliation  Government ayurveda college Thiruvananthapuram  
Address  Professor and HOD Department of Kayachikitsa Government ayurveda college Thiruvananthapuram Kerala - 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9847457084  
Fax    
Email  ambikachitharanjan@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college Thiruvananthapuram , Thiruvananthapuram, Kerala , India 695001 
 
Primary Sponsor  
Name  Government Ayurveda college Thiruvananthapuram Thiruvananthapuram Kerala  
Address  Government Ayurveda college Thiruvananthapuram Kerala , India 695001 
Type of Sponsor  Other [Government Ayurveda college Thiruvananthapuram Kerala, Thiruvananthapuram Kerala India 695001] 
 
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 Lakshmi Narayan Gouda   Government Ayurveda college Thiruvananthapuram   OP number 2 Department of Kayachikitsa Government Ayurveda college Thiruvananthapuram - 695001 Thiruvananthapuram - Kerala India
Thiruvananthapuram
KERALA 		 6361003207

lakshmingouda@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Astanga hridaya sutrasthana 18th chapter virechanadhyaya, Procedure details: Avipatthy choornam will be given 25 gm will be given to patient empty stomach for 1 day)
(1) Medicine Name: Shuntyadi kashaya, Reference: chakradatta Grahani chikitsa, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 96(ml), Frequency: bd, Duration: 14 Days
(2) Medicine Name: dadimadi ghritam , Reference: charaka chikitsa 16 pandu chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Duration: 7 Days
(3) Medicine Name: tila taila, Reference: Astanga hrudaya sutrasthana 5th chapter dravadravya adhyaya, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
(4) Medicine Name: avipatthy choornam, Reference: astanga hridaya kalpasthana 2nd chapter virechana kalpadhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 25(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are clinically diagnosed with Irritable Bowel Syndrome fulfilling inclusion and exclusion criteria will be selected.  
 
ExclusionCriteria 
Details  Diagnosed case of inflammatory bowel disease , colonic neoplasm and acute gastrointestinal disease, patients with other systemic disease, patients on prolonged use of NSAID, analgesic or any other drug which may have effect on outcome. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assessed after the completion of the study - 40 days. Improvement in quality of life - assessed by IBS QOL questionnaire.
Change in abdominal pain or discomfort - assessed using VAS score
Change in bowel frequency - subjective analysis
Change in consistency of stool - by Bristol stool chart.  		 Outcome will be assessed after the completion of the study - 40 days.
Improvement in quality of life - assessed by IBS QOL questionnaire.
Change in abdominal pain or discomfort - assessed using VAS score
Change in bowel frequency - subjective analysis
Change in consistency of stool - by Bristol stool chart.  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life will be assessed after the completion of study - 40 days  improvement in quality of life will be assessed after the completion of the study - 40 days 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   N/A 
Date of First Enrollment (India)   25/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Patients who are presenting with complaints which are satisfying the inclusion criteria’s will be selected from government ayurveda college Thiruvananthapuram OPD. Evaluation will be made on the subjective criteria’s such as IBS quality of life questionnaire , change in frequency and consistency of stool based on Bristol stool chart. Change in abdominal pain or discomfort will be assessed by VAS score.  
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