| CTRI Number |
CTRI/2026/02/103650 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study on bowel nosodes and individualised Homoeopathic medicine in treatment of Irritable Bowel Syndrome |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF BOWEL NOSODES WITH INIVIDUALISED HOMOEOPATHIC MEDICINES IN TREATMENT OF IRRITABLE BOWEL SYNDROME -SINGLE BLIND, COMPARATIVE
RANDOMIZED CONTROLLED TRIAL 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 |
Priyavani Panwar |
| Designation |
Pg scholar |
| Affiliation |
National homoeopathic medical college , Lucknow |
| Address |
State National homoeopathic medical College and hospital viraj khand 1 Gomti Nagar Lucknow UP 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8439856525 |
| Fax |
|
| Email |
himanshu.sid96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Chandrabhanji Hiwrale |
| Designation |
Lecturer |
| Affiliation |
National homoeopathic medical college , Lucknow |
| Address |
State National homoeopathic medical College and hospital viraj khand 1 Gomti Nagar Lucknow UP
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9473854481 |
| Fax |
|
| Email |
rhreshma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyavani Panwar |
| Designation |
Pg scholar |
| Affiliation |
National homoeopathic medical college , Lucknow |
| Address |
State National homoeopathic medical College and hospital viraj khand 1 Gomti Nagar Lucknow UP
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8439856525 |
| Fax |
|
| Email |
himanshu.sid96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of State National Homoeopathic Medical College And Hospital 1 viraj khand Gomti Nagar Lucknow Uttarpradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Priyavani Panwar |
| Address |
State National Homoeopathic Medical College And Hospital viraj khand 1 Gomti Nagar Lucknow UP |
| 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 Priyavani Panwar |
State national homoeopathic medical College and hospital |
OPD-4 Department of homoeopathic Materia Medica State national homoeopathic medical College and hospital viraj 1 Gomti Nagar Lucknow UP
Lucknow
UTTAR PRADESH |
8439856525
himanshu.sid96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic commitee of state national homoeopathic medical College and hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bowel nosodes |
Bowel nosodes are given as per homoeopathic principles in different potencies. Follow up is taken after every 15 days.
Calibration of scale is( Ibs-Qol and Ibs -sss ) is done before and after treatment |
| Comparator Agent |
Indivudualised homoeopathic medicine |
Individualised homoeopathic medicine is given as per homoeopathic principle in various potency . 4 globules orally . Follow up after 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient fulfilling the ROME III criteria.
2 Patient who has a score of zero to 299 in IBS-SSS Score.
3 Patient of both sexes, all religion and socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1 Patients who had prior abdominal surgery which may cause bowel symptoms similar to IBS.
2 Patients with evidence of abnormal laboratory or imaging findings inconsistent with IBS.
3 Patients presenting with unintentional weight loss, rectal bleeding, family history of colorectal cancer onset at older age.
4 Currently participating in another trial studies.Patients with uncontrolled co-morbidites (hypertension, diabetes mellitus and hyperthyroidism) .
5 Pregnant females, lactating mothers and women who are planning for pregnancy in near future.
6 Patients who are not willing to participate in the study and currently participating in another trial studies.
7 Current use of long-term systemic steroids, immunosuppressants, or other therapies likely to interfere with the assessment of homoeopathic treatment outcomes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study, it is expected in improvement of IBS-SSS. This measure overall symptoms reduction or relief as the main indicators of treatment efficacy. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The improvement of patient quality of life is measured by Ibs-Qol questionnaire. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/02/2026 |
| 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 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 is a prevalent chronic functional bowel disorder characterized by abdominal pain or discomfort and altered bowel habits in the absence of detectable structural abnormalities. Diagnosis depends upon recognizing clinical symptoms pattern (using ROME III criteria) & no clear diagnostic markers exists due to it’s multifactorial nature of IBS . Severity of symptoms varies and can significantly hamper quality of life. Currently, there is no curative therapy; treatment is based upon symptoms control due to various pathophysiological Mechanisms that underline IBS subtypes. Bowel nosodes which are prepared from potentisation of Non lactose fermenting bacilli present in gut flora turn out effective for IBS. Bowels nosodes turns out effective in treatment of IBS because directly or indirectly it alter gut flora which turns out effective in improvement of IBS and thereby reduction in improvement of IBS-SSS value.
At the end of study it is expected that by using bowel nosodes in treatment of IBS helps in improvement of symptoms severity which is measured by using IBS - SSS score. Also the improvement in patient’s quality of life is expected to get significantly improved which is calibrated by IBS-QOL questionnaire. |