| CTRI Number |
CTRI/2025/08/093212 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic interventions in Ulcerative colitis |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Kutaja Rasa Kriya in the Management of Mild to Moderate Cases of 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 Abhishek Jaiswal |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra Faculty of Ayurveda
Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9651899243 |
| Fax |
|
| Email |
abhishekjaiswaluno@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rahul Sherkhane |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra Faculty of Ayurveda
Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8233829723 |
| Fax |
|
| Email |
rahulsherkhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Jaiswal |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalyatantra Faculty of Ayurveda
Institute of Medical Sciences
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9651899243 |
| Fax |
|
| Email |
abhishekjaiswaluno@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra |
| Address |
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Jaiswal |
Sir Sunderlal Hospital Banaras Hindu University |
OPD No.12,14,16A
Indian Medicine Wing
Department of Shalyatantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH |
9651899243
abhishekjaiswaluno@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K519||Ulcerative colitis, unspecified. Ayurveda Condition: PITTAJA-ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutaja , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Takra), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Mesalamine | 1.2 gm BD, For 3 months, via oral route |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
mild to moderate type (Mayo score 3 to 10) of ulcerative colitis
previously diagnosed cases of ulcerative colitis |
|
| ExclusionCriteria |
| Details |
Toxic mega colon/Fulminant type of disease
Severe type of Ulcerative colitis (Mayo score 11-12) who need corticosteroid for their management.
Known active infection (TB, HIV, C. Difficile, CMV)
Gastro intestinal perforation
Infective colitis, ischemic colitis, solitary ulcer syndrome, irradiation colitis
Patients with known history of malignancy
Pregnant females.
Patients with co morbid illness including DM, Stage III or above, CHF, chronic pancreatitis, severe liver and renal diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of efficacy of Ayurvedic trial drug in mild to moderate Ulcerative Colitis |
monthly assessment for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of efficacy of trial drug on the basis of endoscopic parameters, serological parameters & histopathological parameters |
monthly assessment for 3 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/09/2025 |
| 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="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
|
This clinical study aims to evaluate the efficacy of Kutaja Rasa Kriya, a classical Ayurvedic formulation, in managing mild to moderate ulcerative colitis (UC). UC is a chronic inflammatory bowel disease characterized by mucosal inflammation and recurrent episodes of bloody diarrhea, abdominal pain, and urgency. Conventional treatments often involve corticosteroids and immunomodulators, which can be effective but are associated with side effects and drug dependency.
In Ayurveda, UC shows similarities with conditions such as Atisara, Pravahika, and Grahani, especially the Pittaja and Raktaja types. Classical texts recommend therapies involving Agni deepana (digestive stimulation), Ama pachana (detoxification), Rakta sthambhana (hemostasis), and Grahi (astringent) herbs. Kutaja (Holarrhena antidysenterica) and Dadima (Punica granatum) are identified in classical texts for their astringent, anti-diarrheal, and hemostatic properties, making them suitable for UC management.
This randomized controlled trial involves two groups:
A total of 54 patients (27 per group) will be enrolled based on specific inclusion criteria, including a Mayo score of 3–10. Patients will be assessed clinically and via endoscopic, serological, and histopathological parameters over 3 months, with monthly follow-ups.
The study aims to provide scientific evidence for the therapeutic potential of Ayurvedic medicine in ulcerative colitis and to compare its efficacy against standard treatment. The need arises due to the increasing burden of IBD in India, limitations of existing treatments, and the underexplored immunomodulatory effects of Ayurvedic formulations in UC.
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