| CTRI Number |
CTRI/2024/06/068767 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in irritable bowel syndrome. |
|
Scientific Title of Study
|
An experimental study to ascertain the effectiveness of homoeopathic medicines in the management of irritable bowel syndrome |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hasti Bharatbhai Dekivadiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
8849062457 |
| Fax |
|
| Email |
210409204002@paruluniversity.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hitarth N. Mehta |
| Designation |
HOD Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot
Rajkot GUJARAT 360001 India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Hasti Bharatbhai Dekivadiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot
Rajkot GUJARAT 360001 India |
| Phone |
8849062457 |
| Fax |
|
| Email |
210409204002@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot - 360001,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot - 360001,
Gujarat, India |
| 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 |
| Hasti Bharatbhai Dekivadiya |
Sainath Homoeopathic Hospital |
Department of Practice of Medicine,
Rajkot Homoeopathic Medical College,
B/H Jainath Complex,
Makkam Chowk,
Gondal Road,
Rajkot - 360001 Rajkot GUJARAT |
8849062457
210409204002@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Research- Rajkot Homoeopathic Medical College (RHMC), PARUL UNIVERSITY, GUJARAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic
medicines - Nux Vomica, Argentum Nitricum, Lycopodium, Etc. |
Homoeopathic
medicines selected on the basis of Individualisation.
Selection of potency, doses and
repetition will be done
according to susceptibility of the Patient.
Mode of Administration:- Oral Route.
Potency:- 30, 200, 1m on the basis of susceptibility of the patient.
Frequency of repetition:-
Every week and modified as per
requirement Patient will be
followed up for duration of 9
months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of both the sexes, irrespective of religion and caste.
2. Pre-diagnosed and new cases diagnosed with Rome III criteria.
3. Patient who will give consent to participate in the study with at least 6 follow-ups. |
|
| ExclusionCriteria |
| Details |
1. Age- less than 20 and more than 50
2. Pregnancy
3. Cases with advanced & irreversible pathology
4. Cases with irregular follow-ups. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain the effectiveness of Homoeopathic
Medicines in cases of Irritable bowel syndrome using G.S.R.S.(Gastrointestinal Symptoms Rating Scale) for IBS. |
There will be improvement in cases of IBS after prescribing suitable Homoeopathic Medicines will be achieved within 9 months of period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant improvement, sense of well being with no complaints or relapse of symptoms.
Moderate improvement, patient relieved from presenting complaints in frequency & intensity.
Status quo, when there is neither increase or decrease in the complaints of the patient. |
This may be also achieved with the time frame of Primary outcome that is within 9 months |
|
|
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)
|
24/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/06/2024 |
| 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 said that all the disease begins in gut. Disturbed gut is responsible for development of different diseases and it can also affect the person’s day to day life. Out of all the gastrointestinal disorders Irritable Bowel Syndrome is one of the most common functional disorder. Global burden of disease, studies have shown that IBS affects people world wide.It is estimated that 1 out of 10 people from world suffers from IBS.[1] Burden of IBS varies from 7%-24% across the globe, in south east Asia and middle east countries it is about 7%.[1] Prevalence of IBS in Asian countries is rising which shows that, cases of IBS varies between 4.2%-7.5% in India.[2] Prevalence of IBS is common in both sexes but females are at higher risk. IBS is significantly lower in >50 years of age as compared to <50 years. IBS significantly affects the individual and their quality of life. Notably it has been found that developing countries adopting westernized diet, lifestyle and behavior that might associated with increased risk of developing IBS. Psychological factors like stress, anxiety, depression may frequently present with IBS and it exacerbate the condition. IBS has varied presentation, so the management focus towards the amelioration of the symptoms. At present, the drugs available for the treatment have only a modest effect on the symptoms improvement. Homoeopathy being wholestic mode of treatment, it does not focus only on the diseased part, but it consider the person as a whole including mind and body. It believes that signs and symptoms are the outward reflection of internal derangment of vital force. Totality is formed by combing all these individulized symptoms and signs, then medicine is prescribed which helps to streghten the deranged vital force. In this way it can help in relieving pain and decreasing frequency of IBS |