| CTRI Number |
CTRI/2024/08/073153 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Individualised Homoeopathic Medicine in cases of Irritable Bowel Syndrome using Synthesis repertory |
|
Scientific Title of Study
|
Utility of individualised Homoeopathic medicine selected using Synthesis Repertory in cases of Irritable Bowel Syndrome and assessing cases by IBS-SSS
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemang Panchal |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Repertory ,Jawaharlal Nehru Homoeopathic Medical College,Parul University,Limda,Waghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990563447 |
| Fax |
|
| Email |
panchalhemang26399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Professor, Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Repertory ,Jawaharlal Nehru Homoeopathic Medical College,Parul University,Limda,Waghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jhpatel2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Professor, Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Repertory ,Jawaharlal Nehru Homoeopathic Medical College,Parul University,Limda,Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jhpatel2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College And Hospital , Parul University, Post- Limda, Taluka - Waghodia , District - Vadodara ,Gujarat -391760 , India |
|
|
Primary Sponsor
|
| Name |
Dr Hemang Panchal |
| Address |
Jawaharlal Nehru Homoeopathic Medical College And Hospital , Parul University, Post- Limda, Taluka - Waghodia , District - Vadodara ,Gujarat -391760 , India |
| 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 Hemang Panchal |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
Jawaharlal Nehru Homoeopathic Medical College. Department Of Practice of Medicine,Post Graduation Division,Parul Universit y,P.O.Limda,Dist.Wagh odia,Ta.Vadodara Gujarat 391760.
Vadodara
GUJARAT |
7990563447
panchalhemang26399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College And Hospital INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K58||Irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Individualized Homoeopathic Medicines like Argentum Nitricum, Asafoetida, Nuv Vomica, Podophyllum, China etc. are prescribed on the basis of homoeopathic principles. Each dose will be given orally to the patient. Case repertorisation will be done by Synthesis repertory. Potency and Repetition of the dose of homoeopathic medicine will be done as per the requirements of the case.Patient will be given treatment for 3 months. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases diagnosed as per ROME’s IV Criteria.
2. Patients between 25-50 years of age.
3. Both gender.
4. All Socio-economic Group. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients suffering from other GI disturbances. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study utility of individualized homoeopathic medicine selected using synthesis repertory in cases of Irritable Bowel Syndrome . |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To clinically assess treatment outcome in the cases of Irritable bowel syndrome using IBS-SSS |
3 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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
- Irritable Bowel Syndrome (IBS) is one of the most frequently encountered gastro-intestinal disorders in clinical practice presenting with abdominal pain, altered bowel habits and absence of detectable organic pathology. There are 3 variations in clinical presentations –spastic colon (chronic abdominal pain and constipation), alternating constipation and diarrhoea, and chronic, painless diarrhoea.
- The main causation of irritable bowel syndrome is due to disturbance in the action of large intestinal muscles due to stress, emotional upset, fear, low fiber diet affects nerves serving in the digestive system. Homoeopathy is widely accepted mode of treatment based on totality of symptoms and individualization and repertorization done using synthesis repertory and is able to cure IBS.
- The homeopathic medicines are selected after a full individualizing examination according to guidelines mentioned by Dr Hahnemann in Organon of medicine also case-analysis will be done , which includes the medical history of the patient, physical and mental constitution etc.
- IBS will be clinically accessed using IBS-SSS .Potency will be selected on basis of Individual. Study will be conducted in Jawaharlal Nehru Homoeopathic Medical College and Hospital enrolling 40 patients.
|