| CTRI Number |
CTRI/2025/02/079876 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Individualised homoeopathic medicine in case of Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicine on patients of irritable bowel syndrome with history of adverse parenting
An open label prospective clinical study. |
| 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 Shubhranil Mandal |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National institute of homoeopathy
Block GE Sector 3 Salt Lake Kolkata 700106 department of practice of medicine opd number 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
8274994434 |
| Fax |
|
| Email |
shubhranil1517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhranil Mandal |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National institute of homoeopathy
Block GE Sector 3 Salt Lake Kolkata 700106 department of practice of medicine opd number 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
8274994434 |
| Fax |
|
| Email |
shubhranil1517@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Pal |
| Designation |
Professor and H.O.D practice of medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National institute of homoeopathy
Block GE Sector 3 Salt Lake Kolkata 700106 department of practice of medicine opd number 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
7044524996 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy GE block sector 3 salt lake Kolkata 700106 opd 24 department of kateria medica |
|
|
Primary Sponsor
|
| Name |
Dr Shubhranil Mandal |
| Address |
National institute of homoeopathy
Block GE Sector 3 Salt Lake Kolkata 700106 department of practice of medicine opd number 24
|
| 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 Shubhranil Mandal |
National Institute of Homoeopathy |
National institute of homoeopathy
Block GE Sector 3 Salt Lake Kolkata 700106 department of practice of medicine opd number 24
Kolkata
WEST BENGAL |
8274994434
shubhranil1517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine in cases of Irritable bowel disease |
Individualised homoeopathic medicine in cases of Irritable bowel disease for 6 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having irritable bowel syndrome according to Rome (IV) criteria.
2. Patients of IBS having history of adverse parenting (Permissive and Authoritarian) according to parenting authority questionnaire (PAQ) which will be also explained.
3. Patients of age between 18-45 years.
4.Patients of all religions, gender and socio-economic conditions.
5. Patients who are literate, willingness to participate in the study and to give written informed consent and if patients are willing but illiterate then they will be explained the importance of the study and consent will be written by physician and thumb impression will be taken. |
|
| ExclusionCriteria |
| Details |
1. Patients who are diagnosed with unstable mental or psychiatric conditions.
2. Patients who are suffering from severe systemic diseases.
3. IBS patients with uncontrolled or life-threatening complications and immune compromised conditions.
4. Pregnant and lactating women.
5. Patients having substance abuse and/or dependence.
6. Patients who are under the treatment homoeopathic medicines, should have minimum wash out period of 2-3months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IBS SEVERITY SCORING SYSTEM |
baseline and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/02/2025 |
| 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="6"
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
|
With research question of does individualized homoeopathic medicine have any significant effect on patients suffering from IBS reflected with history of adverse parenting the study has been proposed. Null Hypothesis: There is no significant change in IBS - Severity Score Scale (IBSSSS) using individu-alized homoeopathic medicine in patients of IBS with a history of adverse parenting. Alternative Hypothesis: There is significant change in IBS Severity Score Scale (IBSSSS) using individualized homoeopathic medicine in patients of IBS with a history of adverse parenting. With the aim to assess the effectiveness of individualized homeopathic medicine in management of patients of IBS associated having a history of adverse parenting.with objective To determine the change in IBS Severity Score Scale (IBSSSS) using individualized homoeopathic treatment in patients with a history of adverse parenting among IBS patients and to analyse the types of history of adverse parenting among IBS patients of age group of 18 to 45 years |