| CTRI Number |
CTRI/2020/09/027773 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
04/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF AYURVEDIC MEDICINE IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME. |
|
Scientific Title of Study
|
EFFICACY OF WHOLE SYSTEM AYURVEDA PROTOCOL IN IRRITABLE
BOWEL SYNDROME–A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devayani Suresh Patankar |
| Designation |
BAMS |
| Affiliation |
KLEUs Shri B.M.Kankanwadi Ayurveda Mahavidyalay PG Studies and Medical Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya , Shahpur
Belgaum
KARNATAKA
590003
India |
| Phone |
8766920429 |
| Fax |
|
| Email |
patankardevayani94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavraj R Tubaki |
| Designation |
MD PH.D.VSF, Professor & HOD Dept of Kayachikitsa |
| Affiliation |
KLEUs Shri B.M.Kankanwadi Ayurveda Mahavidyalay PG Studies and Medical Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahpur
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavraj R Tubaki |
| Designation |
MD PH.D.VSF, Professor & HOD Dept of Kayachikitsa |
| Affiliation |
KLEUs Shri B.M.Kankanwadi Ayurveda Mahavidyalay PG Studies and Medical Research Centre |
| Address |
KAHERS Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahpur
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B.M.Kanakanwadi Ayurveda Mahavidyalaya,Shahpur,Belgavi. |
|
|
Primary Sponsor
|
| Name |
KLE UNIVERSITY |
| Address |
KAHERs Shri B.M.Kanakanwadi Ayurveda Mahavidyalaya,Shahpur,Belgavi. |
| 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 Devayani Suresh Patankar |
OPD , IPD |
KAHERs Shri B M Kanakanvadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre,Shahpur
Belgaum
KARNATAKA |
8766920429
patankardevayani94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, (2) ICD-10 Condition: K581||Irritable bowel syndrome with constipation, (3) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mebeverine and Isabgula Husk
|
GROUP A - Mebeverine 2oomg BD and Isabgula Husk 15gm HS for 60 days
|
| Intervention |
Whole system research of Ayurveda Interventions
|
GROUP-B Whole system research of Ayurveda Interventions for 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Irrespective of religion , occupation ,economic status
2.Subjects fulfilling the Diagnostic criteria for IBS Rome IV
|
|
| ExclusionCriteria |
| Details |
1.Inflammatory bowel disorder
2.Malabsorbtion syndrome
3.Intestinal Tuberculosis –colonic
4.CA colon
5.Constipation caused by a condition called Paralytic ileus
6.Patient with any drug or alcohol dependancy
7.Patient have had an allergic reaction to Mebeverine or any other medicines in the past.
8.Patient with any co-morbidities necessitating long term drug treatment ,Rhumatoid arthritis , Tuberculosis etc.
9.Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.IBS Adequate Relief
2.IBS Symptoms Severity Scale
|
baseline ,15th day ,30th day ,45th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AbdominalPain-VAS(0-10) |
baseline ,15th day ,30th day,45th day, 60th day |
| Stool Consistency-Bristol Stool Form(BSF) |
baseline ,15th day ,30th day ,45th day, 60th day |
| IBS-quality of life |
baseline ,15th day ,30th day ,45th day, 60th day |
| IBS global improvement Scale(IBS-GIS) |
baseline ,15th day ,30th day ,45th day, 60th day |
| IBS-related bowel urgency |
baseline ,15th day ,30th day ,45th day, 60th day |
| Hamilton Anxiety Rating Scale |
baseline ,15th day ,30th day ,45th day, 60th day |
| Hamilton Depression Rating Scale |
baseline ,15th day ,30th day ,45th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study to evaluate the efficacy of Whole System Ayurveda Protocol in the management of Irritable Bowel Syndrome which will be done in the period of 60 days .The study will be conducted at KAHERs Shri B.M.K Ayurveda Mahavidyalaya and Research Centre owned KLE Ayurveda Hospital Shahpur ,Belgavi ,Karnataka,India. The outcome is to prove the Efficacy of Whole System Ayurveda Protocol in better management of Irritable Bowel Syndrome.End Point is the controlled Irritable Bowel Syndrome .
|