| CTRI Number |
CTRI/2022/03/041485 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
28/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in the management of pain in the abdomen |
|
Scientific Title of Study
|
Efficacy of homoeopathic medicine in the management of irritable bowel syndrome by using synthesis-repertorium homeopathicum syntheticum 9.1 repertory and to assess the quality of life |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARTHIK R S |
| Designation |
Post Graduate Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
OPD Room No 2C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
8943899535 |
| Fax |
|
| Email |
karthikrs1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Senthil Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
OPD Room No 2C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9842780556 |
| Fax |
|
| Email |
drjsenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Senthil Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
OPD Room No 2C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9842780556 |
| Fax |
|
| Email |
drjsenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
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 |
| Dr J Senthil Kumar |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No 2C-2 - PG Dept of Repertory OPD Unit
Ground Floor
Hospital Block
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU |
9842780556
drjsenthil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K581||Irritable bowel syndrome with constipation, (2) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, (3) ICD-10 Condition: K589||Irritable bowel syndrome without diarrhea, (4) ICD-10 Condition: K582||Mixed irritable bowel syndrome, (5) ICD-10 Condition: K588||Other irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
Homoeopathic medicines are selected based on individualization. The dose is selected based on the susceptibility of the patient. Medicine is administered via oral route. Follow up is taken in every 15 days. Maximum treatment period per patient under study is 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All cases that fit into the ROME III diagnostic criteria, The patients of all age groups and both sexes, Patients who are pre diagnosed with IBS, Patients irrespective of ethnic groups socio economic status and occupation will be considered
|
|
| ExclusionCriteria |
| Details |
Cases which does not fit Rome III criteria
Cases which have other systemic illness.
Cases with symptoms for less than 3 months
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on the Rome III criteria, clinical symptoms of irritable bowel syndrome are assessed |
At baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is expected that the proposed study will be useful in reducing the symptoms of irritable bowel syndrome and to improve the quality of life of the patients |
At baseline And after 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 is one of the main psychosomatic disorders characterized by recurrent abdominal pain in abdomen, abdominal swelling, diarrhoea, constipation, eructation and flatulence and mucorrhea. In developed countries, its mainly seen in 10 – 15% adults. In India, IBS is seen in almost 4.2 % of the population. In Males the estimate is 4.3% and in females it is 4.0%.Younger people have higher prevalence of irritable bowel syndrome in the population. IBS is psychosomatic in origin and a result of modern life style and presents with lot of clinical symptoms. Experience says that Homoeopathy stands out for its Holistic approach towards diseases. Repertory stands greater height as best approach for any type of cases. Synthesis 9.1 is a very such tool which fulfils the requirement of ailments from, mental generals, physical generals and clinical symptoms., which I am using to find out the similimum. This study is the small attempt to highlight the efficacy of homeopathic similimum achieved by using Synthesis 9.1 repertory in treatment of Irritable Bowel Syndrome. | |