| CTRI Number |
CTRI/2022/12/048261 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| 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
|
Ayurvedic medication in the treatment of Irritable Bowel Syndrome |
|
Scientific Title of Study
|
“Effect of Kalingadi Churna (in constipation predominant) and Dadimastaka Churna (in diarrhea predominant) 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 |
Dr RAJAT THAKUR |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belgavi |
| Address |
Dept. of kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8699410115 |
| Fax |
|
| Email |
thakur.thakur93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belgavi |
| Address |
Dept. of kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur 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 HOD |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belgavi |
| Address |
Dept. of kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belagavi
Dept. of kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahpur Belgavi |
|
|
Primary Sponsor
|
| Name |
Dr RAJAT THAKUR |
| Address |
KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahpur Belagavi |
| 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 |
| Dr RAJAT THAKUR |
KLE Shri BMK Ayurveda Hospital & Research Centre Shahpur Belagavi |
KLE Shri BMK Ayurveda Hospital & Research Centre Shahpur Belagavi OPD 6 OPD 7
Belgaum
KARNATAKA |
8699410115
thakur.thakur93@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for research on human subjects |
Approved |
| Institutional Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K580||Irritable bowel syndrome with diarrhea. Ayurveda Condition: GRAHANIDOSHAH, (2) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalingadi churna, Reference: charak chikitsa 15/101, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: takra), Additional Information: nil | | 2 | Comparator Arm (Non Ayurveda) | | - | Mebeverine and Isabgula Husk | Mebeverine 200mg bd and Isabgula Husk 20 gm HS | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadimastaka churna, Reference: : bhaishajya ratnavali 8/38,39, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: takra), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between the age group of 20 to 60 years
patients of either sex
subjects fulfilling the diagnostic Rome 4 criteria |
|
| ExclusionCriteria |
| Details |
Other subtypes of IBS like mixed and unclassified
Diagnosed with Inflammatory bowel disorders
Known case of CA colon, Intestinal tuberculosis
Patients with chronic alcoholism
Patients with any co-morbidities needs long term drug treatment, rheumatoid arthritis, tuberculosis, uncontrolled diabetes, HTN, etc.
Pregnant or lactating women .
Patient have an allergic reaction to Mebeverine in the past.
Patients on any medications for the management of IBS in the last 30 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
IBS Adequate Relief
IBS symptom severity score |
60 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Gastrointestinal Symptom Rating Scale (GSRS) IBS –Visual Analogue Scale (IBS-VAS) Complete Spontaneous Bowel Movements (CSBMs) Bristol Stool Form (BSF) Hamilton Anxiety Rating scale Hamilton Depression Rating scale IBS quality of life (IBS–Qol)
Stool Examination, Interleukin -6 (IL-6)
|
GSRS,IBS-VAS,CSBMs,BSF, Hamilton Anxiety Rating scale ,Hamilton Depression Rating scale & IBS-Qol on baseline 15th 30th 45th 60th day . Stool Examination & Interleukin 6 on baseline & 60th day
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Irritable bowel syndrome (IBS) is one of the most common functional bowel disorders, with prevalence of 11.2% globally and varying from 4.2% -7.5% in India .IBS being a multifactorial disease, presents with symptoms like abdominal pain, stool irregularities, and bloating associated with somatic, visceral and psychiatric comorbidities. Despite the recent advances, pathophysiology of IBS is not clearly established. So conventional medicine is managing IBS through antispasmodics, antidiarrheals and laxatives symptomatically which on long term are leading to deleterious side effects. This suggests the need of studies on new drugs and disease modifying treatments which help in reducing the recurrence of IBS and also to improve the quality of life without any adverse effects. In an attempt to fill this lacuna, current study is planned with kalingadi churna & Dadimashtaka churna in management of IBS. IBS manifestations and pathology are similar to the Grahani roga explained in Ayurveda |