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CTRI Number  CTRI/2025/06/088081 [Registered on: 02/06/2025] 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 Ulcerative Colitis: A Multi-Center Clinical Study 
Scientific Title of Study   Multicenter double blind placebo (dummy) controlled randomized treat through trial of treatment with ayurvedic formulation and life style modification in patients with mild to moderate ulcerative colitis 
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 
Affiliation  AIIMS Delhi 
Address  7004, CIMR 7th floor Convergence block AIIMS New Delhi
CN Centre AIIMS Delhi, 110029
South
DELHI
110029
India 
Phone  9811388311  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gautam Sharma 
Designation  Professor In Charge 
Affiliation  AIIMS Delhi 
Address  7004,CIMR 7th floor Convergence block AIIMS New Delhi
CN Centre AIIMS Delhi, 110029
South
DELHI
110029
India 
Phone  9811388311  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gautam Sharma 
Designation  Professor In Charge 
Affiliation  AIIMS Delhi 
Address  7004, CIMR 7th floor Convergence block AIIMS New Delhi
CN Centre AIIMS Delhi, 110029
South
DELHI
110029
India 
Phone  9811388311  
Fax    
Email  drgautamsharma12@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneshwar 
AIIMS, Gorakhpur 
AIIMS, Patna 
AIIMS,New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  ICMR, New Delhi 
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 
Dr Manas Panigrahi  AIIMS Bhubaneswar  Dept. of Gastroenterology, AIIMS Bhubaneswar
Khordha
ORISSA 		 9861278332

manaskumarpanigrahi@gmail.com 
Dr Gautam Sharma  AIIMS Delhi  All India Institute of Medical Sciences New Delhi, 110029
South
DELHI 		 26594681

drgautamsharma12@gmail.com 
Dr Saurabh Kedia  AIIMS Gorakhpur  Dept. of Gastroenterology, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH 		 9868428535

dr.saurabhkedia@yahoo.com 
Dr Ramesh Kumar  AIIMS Patna  Dept. of Gastroenterology, AIIMS Patna
Patna
BIHAR 		 7765803112

docrameshkr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
IEC AIIMS   Approved 
IEC AIIMS Bhubaneswar  Submittted/Under Review 
IEC AIIMS Gorakhpur  Approved 
IEC 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:K519||Ulcerative colitis, unspecified. Ayurveda Condition: ATISARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bilvadi Leha, Reference: API part II, Vol I, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 48 Weeks, anupAna/sahapAna: No, Additional Information: The Ayurvedic formulationa and lifestyle recomendations witll be administered with standard care
2Comparator Arm (Non Ayurveda)-Bilvadi Leha Placebo(1) Medicine Name: Bilvadi Leha Placebo, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 48 Weeks, anupAna/sahapAna: No, Additional Information: The Ayurvedic formulation placebo and lifestyle recommendations witll be administered with standard care
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Confirmed cases of mild to moderate endoscopically active ulcerative colitis (UC endoscopic index of severity or UCEIS more than 1) and disease extent beyond rectum and simple clinical colitis activity score between 3-9
2 Patients on stable dose of mesalamine for past 4 weeks
3 Patients on stable dose of azathioprine or 6 mercaptopurine for past 3 months
4 Patients on stable doses of topical therapy for past 2 weeks
5 willing to participate
 
 
ExclusionCriteria 
Details  1 history of oral steroids in the past 4 weeks
2 History of or oral antibiotics within past 2 weeks
3 Patients with severe disease activity
4 Patients with fulminant colitis requiring
hospitalization
5 Patients who have had surgery
6 Patients with Crohns colitis
7 Patients with concomitant GI infection
8 Patients with comorbidities like acute
myocardial infarction chronic kidney
disease or chronic liver disease
9 Patients with significant hepatic renal
endocrine respiratory neurologic or
cardiovascular diseases will also be
excluded
10 Pregnant lactating females
11 Patients with allergy to Ayurvedic formulations
12 Patients with Diabetes
13 Patients with severe co-morbidities
 
 
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  8 weeks and 48 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Response
 		 at 8 and 48 weeks 
Endoscopic response and remission   8 and 48 weeks 
Deep Remission   8 and 48 weeks 
Quality of Life  8 and 48 weeks  
Adverse events   8 and 48 weeks  
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 
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  

Ulcerative colitis is a chronic inflammatory disorder of the GI tract affecting the large intestine causing superficial mucosal inflammation & is characterized by long term relapsing & remitting disease course requiring prolonged treatment for maintenance of remission. Though the exact pathogenesis of UC 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 UC targets the aberrant immune response & is limited by higher cost side effects such as infection & malignancy & limited efficacy hence therapies which can circumvent these barriers are required. Polyherbal Ayurvedic formulations would be effective safe & low cost option for treatment of patients with ulcerative colitis. Though these formulations have been in clinical use for hundreds of years they have not been systematically evaluated in patients with ulcerative colitis.

Bilvadi Avleha is a traditional Ayurvedic formulation a promising herbal drug compound that is being successfully prescribed by Ayurvedic physicians without any side effect since centuries. Its use is mentioned in the Ayurvedic Pharmacopeia of India Part II Volume I & is recommended for use in Agnimandya digestive impairment. Several pre clinical studies which have tested individual constituents of Bilwadi avleha have shown efficacy in animal models of IBD. Therefore Ayurvedic therapy such as Bilwadi avleha would be cost effective safe & associated with minimal side effects & could be an effective treatment option for ulcerative colitis.

Hence through a double blind placebo dummy controlled RCT we will be able to determine the efficacy & tolerance of these formulations which could be an alternative low cost option of treatment of patients with ulcerative colitis. The success of these formulations would also have global relevance & provide a treatment option which would be applicable globally. 

 
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