| CTRI Number |
CTRI/2024/02/063218 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Ulcerative colitis |
|
Scientific Title of Study
|
MULTI DIMENSIONAL COMPLEX AYURVEDIC MANAGEMENT OF RAKTAATISARA(ULCERATIVE COLITIS) A PRE-POST DESIGNED SINGLE ARM CLINICAL STUDY |
| 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 Aena V Pathak |
| Designation |
PhD scholar ,Assistant Professor Kayachikitsa Department |
| Affiliation |
J S Ayurveda Mahavidhyalaya college road Nadiad |
| Address |
J S Ayurveda Mahavidhyalaya College road Nadiad Gujarat 387001
Kheda
GUJARAT
387001
India |
| Phone |
8866858699 |
| Fax |
|
| Email |
aenapathak2094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manish v Patel |
| Designation |
HOD Kayachikitsa department |
| Affiliation |
J S Ayurveda Mahavidhyalaya College road Nadiad Gujarat 387001 |
| Address |
J S Ayurveda Mahavidhyalaya College road Nadiad Gujarat 387001
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manish v Patel |
| Designation |
HOD Kayachikitsa department |
| Affiliation |
J S Ayurveda Mahavidhyalaya College road Nadiad Gujarat 387001 |
| Address |
J S Ayurveda Mahavidhyalaya College road Nadiad Gujarat 387001
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurvedic pharmacy of JS Aurvedic mahavidhaylaya |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidhyalya |
| Address |
J S Ayurveda Mahavidhyalya college road Nadiad Gujarat 387001 |
| Type of Sponsor |
Private medical college |
|
|
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 Aena Pathak |
P D Patel Ayurvedic Hospital |
J S Ayurveic college and P D Patel Ayurvedic Hospital college road Nadiad Gujarat 387001
Kheda
GUJARAT |
8866858699
aenapathak2094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for human resarch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K519||Ulcerative colitis, unspecified. Ayurveda Condition: RAKTATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutaja ghanvati, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -(2) Medicine Name: Lodhra+nagakesar+musta, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: lodhra 1gm+ musta churna 2gm+ nagkesar churna 1 gm(3) Medicine Name: udumbar twaka, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient fulfilling the diagnostic criteria
patient will be selected between 18 to 60 years
patent of ulcerative colitis with s0 to s1 severity |
|
| ExclusionCriteria |
| Details |
Patient of complication like anal fistula,carcinoma and colonic perforation.
severe anemia.
severe systemic illness like Uncontrolled Diabetes,hypertention,AIds,hepatitis,cancer.
patient contraindicated for basti |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out changes in sign and symptoms of ulcerative colitis before and after ayurvedic management |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out changes in heamoglobine,ESR,RBC as well as puscell in stool in the patient of ulcerative colitis before and after administration of ayurvedic tratment |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is single arm open label interventional clinical study with black -box design,total study period of 8 week ,this study consist 29 patients. Objective of this study is to find changes in sign and symptoms of UC. After the intervention of treatment found significant results in all the outcomes. Data is statsticaly significant and there was no ADR found during the treatment. |