| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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. |