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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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