| CTRI Number |
CTRI/2025/05/087639 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
effect of ayurvedic treatments in the management of chronic inflammatory bowel disease |
|
Scientific Title of Study
|
effectiveness of ayurvedic treatment protocol as an add on therapy in modyfying the quality of life of mild to moderate chronic inflammatory bowel 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 |
limsha |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda College,Tripunithura, Ernakulam |
| Address |
department of kayachikitsa government ayurveda college tripunithura ernakulam kerala 682301 India
Ernakulam
KERALA
682301
India |
| Phone |
8606361096 |
| Fax |
|
| Email |
limsham97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindu PR |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda College,Tripunithura, Ernakulam |
| Address |
department of kayachikitsa government ayurveda college tripunithura ernakulam kerala 682301 India
Ernakulam
KERALA
682301
India |
| Phone |
8606361096 |
| Fax |
|
| Email |
drbindhuprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
limsha |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda College,Tripunithura, Ernakulam |
| Address |
department of kayachikitsa government ayurveda college tripunithura ernakulam kerala 682301 India
Ernakulam
KERALA
682301
India |
| Phone |
8606361096 |
| Fax |
|
| Email |
limsham97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura, ernakulam,kerala-682301 |
|
|
Primary Sponsor
|
| Name |
Limsha |
| Address |
government ayurveda college tripunithura ernamkulam 682301 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| limsha |
govrnment ayurveda college,tripunithura |
department of kayachikitsa Government Ayurveda College Tripunithura Ernamkulam 682301 kerala
Ernakulam
KERALA |
8606361096
limsham97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt Ayurveda College Tripunithura Kochi Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K638||Other specified diseases of intestine. Ayurveda Condition: GRAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: sundi samangadi kashayam, Reference: chikitsa manjari - athisara chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed case of chronic IBD
mild to moderate case of IBD
those who are eligible for vasthi |
|
| ExclusionCriteria |
| Details |
IBD with symptoms or extra intestinal manifestation
diagnosed case of other systemic disorder with complication
history of colorectal cancer
pregnancy and lactating women
those who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the quality of life of chronic IBD patients |
every 7th and 14th day from 0 to 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in the signs and symptoms of chronic IBD patients |
every 7th and 14th day from 0 to 28th day |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
26/05/2025 |
| 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
|
it is a comparative study containing one case group who taking ayurvedic treatment methods such as intake of sundisamangadi kashaya with gopichandanadi gulika for 14 days and after that vasthi admistration which is prepared with mahathikthaka gritham, yashti tailam,salmali piccha for 7 days along with dietary modification and allopathic medication and next is control group who taking only allopathic ayurvedic with dietary modification. compare both the groups by using IBDQ-32 questionnaire to assess and compare the improvement in the quality of life of patients in both the group.these study is only applicable in diagnosed case of chronic IBD patients of age 16 - 70 yrs. |