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CTRI Number  CTRI/2025/06/088142 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 02/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ayurvedic Formulation and Lifestyle Changes for mild to moderate Crohn’s Disease: A Multicenter Clinical Trial 
Scientific Title of Study   Multicenter double blind placebo (dummy) controlled randomized trial of treatment with ayurvedic formulation and life style modification in patients with mild to moderate Crohn’s disease.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gautam Sharma 
Designation  Professor In Charge, CIMR, Professor, Cardiology  
Affiliation  All India Inistitute of Medical Sciences, New Delhi 
Address  Centre For Integrative Medicine and Research, 7th Floor, Convergenece Block, AIIMS, New Delhi
Department of Cardiology, CN centre AIIMS, New Delhi
South
DELHI
110029
India 
Phone  26594681  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gautam Sharma 
Designation  Professor In Charge, CIMR, Professor, Cardiology  
Affiliation  All India Inistitute of Medical Sciences, New Delhi 
Address  Centre For Integrative Medicine and Research, 7th Floor, Convergenece Block, AIIMS, New Delhi
Department of Cardiology, CN centre AIIMS, New Delhi
South
DELHI
110029
India 
Phone  26594681  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gautam Sharma 
Designation  Professor In Charge, CIMR, Professor, Cardiology  
Affiliation  All India Inistitute of Medical Sciences, New Delhi 
Address  Centre For Integrative Medicine and Research, 7th Floor, Convergenece Block, AIIMS, New Delhi
Department of Cardiology, CN centre AIIMS, New Delhi
South
DELHI
110029
India 
Phone  26594681  
Fax    
Email  drgautamsharma12@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneshwar 
AIIMS, Patna 
AIIMS,Gorakhpur 
AIIMS,New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research, New Delhi, 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manas Panigrahi  AIIMS Bhubaneswar  Dept. of Gastroenterology, AIIMS Bhubaneswar, 751019
Khordha
ORISSA 
9861278332

manaskumarpanigrahi@gmail.com 
Saurabh Kedia  AIIMS Gorakhpur  Dept. of Gastroenterology, AIIMS Gorakhpur, 273008
Gorakhpur
UTTAR PRADESH 
9868428535

dr.saurabhkedia@yahoo.com 
Gautam Sharma  AIIMS New Delhi  7004, 7th floor, CIMR,AIIMS New Delhi, 110029
South
DELHI 
9811388311

drsharmagautam@gmail.com 
Ramesh Kumar  AIIMS Patna  Dept. of Gastroenterology,AIIMS Patna, 801507
Patna
BIHAR 
7765803112

docrameshkr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
Institute Ethics Committee AIIMS Bhubaneswar  Submittted/Under Review 
Institute Ethics Committee AIIMS Gorakhpur  Approved 
Institute Ethics Committee AIIMS Patna  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K508||Crohns disease of both small andlarge intestine. Ayurveda Condition: ATISARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dadimashtak Churna, Reference: Ayurveda Formulary of India Part 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 52 Weeks, anupAna/sahapAna: No, Additional Information: The Ayurvedic formulation and lifestyle recommendations will be administered with the standard care
2Comparator ArmDrugClassical(1) Medicine Name: Dadimastak Churna Placebo (dummy), Reference: AFI part 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 52 Weeks, anupAna/sahapAna: No, Additional Information: The Placebo(dummy) and lifestyle recomendations will be admisnistered with the standard of care
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Crohns disease 
 
ExclusionCriteria 
Details  1. Patients with proximal small bowel disease (i.e. L4 disease)
2. Patients with severe disease activity
3. Patients with symptomatic strictures
4. Patients with H/O of antibiotic exposure in the past 6 weeks
5. Patients with active perianal disease
6. Patients with abdominal abscess/ intestinal fistulae/ acute obstruction
7. Prior intestinal surgery (subtotal or total colectomy, ileostomy, colostomy) or patients planned for surgery (known fixed symptomatic stenosis or complex fistulae)
8. Patients requiring hospitalization
9. Pregnant, lactating females
10. Patients with Diabetes
11. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded
12. Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease
13. Patients with allergy to Ayurvedic formulations
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical remission defined as SCCAI less than equal to 2   12 and 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical response
Endoscopic remission and response
Quality of life
Adverse events  
12 and 52 weeks 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/07/2025 
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="3"
Months="0"
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  

Crohn’s disease is a chronic inflammatory disorder of the GI tract, affective both small and large intestine, characterized by long-term relapsing and remitting disease course, and requires prolonged treatment for maintenance of remission. Though, the exact pathogenesis of CD is not clear, it probably occurs due to an aberrant immune response causing destruction of intestinal epithelium in genetically pre-disposed individuals under the influence of environmental factors which can negatively affect the gut microbiome. The present treatment for CD targets the aberrant immune response and is limited by higher cost, side effects such as infection and malignancy, and limited efficacy, hence, therapies which can circumvent these barriers are required.

Polyherbal Ayurvedic formulations would be effective, safe and low cost option for treatment of patients with Crohn’s disease. Though these formulations have been in clinical use for hundreds of years, they have not been systematically evaluated in patients with Crohn’s disease. Dadimastak Churna is a traditional polyherbal Ayurvedic formulation, comprising of 14 natural constituents and pomegranate (dadima) is chief ingredient of dadimashtaka churna. It has been mentioned in the Ayurvedic Formulary of India and has been used for centuries in the treatment of diarrhoea, indigestion, dysentery and loss of appetite. Dadimashtak churna has also been advised by the Ayurveda Standard treatment guidelines by Ministry of Ayush for the treatment of Atisara, characterized by chronic diarrhea, a cardinal symptom of Crohn’s disease.

Hence, through a double blind placebo (dummy)controlled RCT plan to determine the efficacy and tolerance of Dadimastak Churna, as an alternative low cost option of treatment of patients with Crohn’s disease. The success of these formulations would also have global relevance and provide a treatment option which would be applicable globally.

 
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