| CTRI Number |
CTRI/2021/01/030781 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of treatment using Takra in the management of Grahani Dosha (Irritable bowel syndrome) |
|
Scientific Title of Study
|
A clinical trial to evaluate the effect of specialized treatment protocol using Takra in the management of Grahani Dosha with special reference to Irritable bowel syndrome |
| Trial Acronym |
STPTGDIBS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshan Mohan Mahulkar |
| Designation |
Post Graduate Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 618 6th floor Dept of Kayachikitsa Academic C block All India Institute of Ayurveda Sarita Vihar New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
8237789211 |
| Fax |
|
| Email |
darshanmahulkar94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vittal G Huddar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 621 6th floor Dept of Kayachikitsa Academic C block All India Institute of Ayurveda Sarita Vihar New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9986697942 |
| Fax |
|
| Email |
drvghuddar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar Harti |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no 604 6th floor Dept of Swasthavritta Academic C block All India Institute of Ayurveda Sarita Vihar New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
| 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 Darshan Mahulkar |
All India Institute of Ayurveda |
Room No. 618 6th floor Dept Of
Kayachikitsa Academic C block All India
Institute of Ayurveda
Gautampuri Sarita
Vihar New Delhi
110076
New Delhi
DELHI |
8237789211
darshanmahulkar94@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: Grahani Dosha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dadimastaka Churna with Takra
Balbilwa Churna and Musta Churna with Takra
Panchasakara Churna with warm water |
Dadimastaka Churna 6gm with 100 ml of Takra empty stomach
Balbilwa Churna 3gm and Musta Churna 6gm with 100 ml of Takra twice a day before food
Panchasakara Churna 3gm at bed time with warm water
above intervention is along with specialized treatment protocol diet modifications
Duration 30 Days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients irrespective of sex, religion, occupation will be selected for study.
2. Patients having pratyatma lakshana of Grahani Dosha especially – Atisrushtam or Ativibadhham or Atidravam malapravritti (altered bowel
habits), Trushna, Arochaaka, Vairasya, Praseka, Tamaka, Shoona pada,
Shoona kara, Asthi-parva ruja, Chhardi, Jwara, Louha-ama-gandhi
tiktamlodgara.
3. The patients who are diagnosed with IBS according to standard ROME IV criteria.
4. Previously diagnosed case of IBS.
5. Able and willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Mixed infection with parasites such as round worms, hook worms etc.
1. Ulcerative colitis, Crohn’s disease, gastric ulcerations and other inflammatory
bowel conditions.
2. Infectious disorders like Intestinal tuberculosis etc.
3. Patients with evidence of malignancy.
4. Patents with diabetes mellitus (FBS >126 mg/dl, PP >200 mg/dl), poorly
controlled hypertension, Thyroid disorders and any other autoimmune disorders.
5. Amoebic dysentery, acute diarrhoea.
6. Lactose intolerance patients.
7. Abuse of drug or alcohol.
8. Presence of other somatic or mental disorder requiring medication.
9. Patients on prolonged medication with NSAIDs, analgesics or any other drugs
that may have an influence on the outcome of the study.
10. History of hypersensitivity to any of the trial drugs or their ingredients.
11. Patients who have completed participation in any other clinical trial during the
past 6 months which is interfering with the results of Grahani Dosha.
12. Patients with bleeding per rectum.
13. All the types of atisara, Antraja krimija patients and any other conditions
interfering with the results of Grahani Dosha / IBS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama |
0th day, 15th day, 30th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Nutritional assessment of patient before and after the treatment.
2. To Improvement the quality of life. |
0th day, 15th day, 30th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
The Thesis study will be published in reputed journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - Provided I due credit
- By what mechanism will data be made available?
Response (Others) - On request subject to institutional consent
- For how long will this data be available start date provided 19-01-2023 and end date provided 19-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Introduction: Grahani dosha described in classical text books of Ayurveda represents a group of
disorders of digestive system caused by impairment of Agni. The cardinal features of Grahani dosha explained in the classical text books of Ayurveda,
have at most similarities with the clinical features of Irritable Bowel Syndrome (IBS) as described
in contemporary medicine. This is one of the common clinical problems among patients attending
gastroenterology clinics. The main clinical features of this ailment are abdominal pain associated
with an altered bowel habit (may present with diarrhoea or constipation or intermittently both) in
the absence of any structural pathology . And the management of this disease is having limitations
in the present scenario of the contemporary science. All acharyas highlighted in classical texts which are Laghutrayi’s and Bruhatrayi’s, which
possess Deepana, Grahi & Laghu Gunasv
. Due to Swadu-amla rasa, Sandra-avidahi guna it
pacifies Vata Dosha, due to Madhur Vipaka it pacifies Pitta dosha, due Kashay rasa, Ushna and
Vikashi and Ruksha it pacifies Kapha dosha. So, by looking efficacy of Takra in Grahani which
is useful in practice.
Objective: Primary objective – Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama. Secondary objective – To improve the quality of life.
- Nutritional assessment before and after treatment of patient.
Methodology: Study type: Interventional clinical study
Design: Pre-test and Post-test design Allocation: Single arm Masking: Open label Primary Purpose: Treatment Sample size: 30 Group intervention: Dadimastaka
churna 6
gm with 100 ml of Takra Balbilwa Churna 3gm and Musta Churna 6 gm with 100 ml Takra Panchasakara Churna with wam water Duration: 30 days Followup: 30 days. |