| CTRI Number |
CTRI/2018/01/011628 [Registered on: 31/01/2018] Trial Registered Prospectively |
| Last Modified On: |
07/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda Management of Irritable Bowel Syndrome |
|
Scientific Title of Study
|
Efficacy of Whole System Research Ayurveda Interventions on Irritable Bowel Syndrome –Randomized Controlled Clinical Trail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Teja D Naik |
| Designation |
PG Scholar |
| Affiliation |
KAHER |
| Address |
KAHER, Shri B.M.K.AyurvedaMahavidyalaya,
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9545285222 |
| Fax |
|
| Email |
teja.d.naik13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and Head Department of Kayachikitsa |
| Affiliation |
KAHER |
| Address |
KAHER, Shri B.M.K.AyurvedaMahavidyalaya,
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and Head Department of Kayachikitsa |
| Affiliation |
KAHER |
| Address |
KAHER, Shri B.M.K.AyurvedaMahavidyalaya,
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Pharmacy, Khasbaug, Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Teja D Naik |
| Address |
KAHER, BMK Ayurveda Hospital, Shahapur, Belgaum |
| 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 Teja D Naik |
KAHER ayurveda hospital |
KAHER, Shri BMK Ayurveda Hospita,Shahpur
Belgaum
KARNATAKA |
9545285222
teja.d.naik13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, Rome IV Criteria for diagnosing IBS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kalingadi churna |
3 gm twice a day orally for 60 days |
| Intervention |
Whole system Approach like kutaja ghana vati |
Kutaja ghana vati 500 mg orally three times a day for 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals between the age group of 20 to 60 years fulfilling diagnostic criteria for IBS(Rome IV) of either sex.
2.Either sex.
|
|
| ExclusionCriteria |
| Details |
1.Patient on any Intervention for IBS in the period of last 4 weeks
2.Patients with known/history of Carcinoma Colon, ulcerative colitis
3.Patients with alcohol dependency or drug dependency.
4.Pregnant or lactating women
5.Patients suffering from major systemic illness necessitating long term drug treatment, Rheumatoid arthritis, tuberculosis, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.IBS Adequate Relief (IBS-AR)
2.IBS Symptom Severity Score (IBS-SSS)
|
60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Abdominal Pain- VAS (0-10)
2.Stool Consistency- Bristol Stool Form (BSF)
3.Stool frequency- Numbers/day
4..Complete Spontaneous Bowel Movements (CSBMs)- Constipation
5.IBS global improvement Scale (IBS-GIS)
6.IBS quality of life (IBS-QOL) -
7.Gastrointestinal symptom rating scale (GSRS)
8.Hamilton Anxiety Rating Scale
9.Hamilton Depression Rating Scale
|
60th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2018 |
| Date of Study Completion (India) |
11/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Considering lacuna in IBS management and Ayurveda
research issues, current study is planned to explore the efficacy of Whole
System Research(WSR) approach of Ayurveda interventions in IBS. |