| CTRI Number |
CTRI/2024/12/077702 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for constipation in children |
|
Scientific Title of Study
|
Individualized homoeopathic medicines in the treatment of functional constipation in
children: A double-blind, randomized, placebo-controlled pilot trial using different
homoeopathic repertories |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-1058 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdul Karim |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3 (Repertory) and room no. 2 (Pediatrics), 12, Gobinda Khatick road
Kolkata
WEST BENGAL
700046
India |
| Phone |
8334977476 |
| Fax |
|
| Email |
abdulkarim13068@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3 (Repertory), 12, Gobinda Khatick road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3 (Repertory), 12, Gobinda Khatick road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick road, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick road, Kolkata 700046 |
| Type of Sponsor |
Government 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 Abdul Karim |
D N De Homoeopathic Medical College and Hospital |
Department of Repertory OPD no. PG3 and OPD NO 2 (Paediatric OPD), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL |
08334977476
abdulkarim13068@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This arm will receive placebo, identical in appearance with the verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the
individual requirement of the cases. Management guidelines will be given as in the experimental arm. Both medicines and placebos will be re-packed in identical glass bottles and labeled with code, name of the medicine, potency
and will be dispensed according to the random number list. And the concomintant cares are the ESPGHAN/NASPGHAN guidelines suggest ensuring normal fiber and fluid intake, along with regular physical activity, combined with education to clarify the condition. For children with a developmental age of at least 4 years, toilet training is also included in the treatment. Its important to educate both patients and parents about the underlying mechanisms of FC and the related issue of fecal incontinence. Dose: Individualized. Frequency: Individualized. Route of administration: per oral Duration of therapy: 3 months. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage and concomitant care. |
The enrolled patients of Functional constipation will be treated with IHMs. Intervention is planned as administering indicated homoeopathic remedy in centesimal potencies, as
decided appropriate to the case or condition. In centesimal scale, each dose shall
consist of 4 globules (no.40) of cane sugar, medicated with the indicated
medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with
empty stomach; dosage and repetition depending upon the individual
requirement of the cases. Patients will be advised to refrain from handling the
globules or from eating, drinking, brushing teeth within 30 minutes of taking
the globules and will be asked to suck the globules rather than simply
swallowing those. Single individualized medicine will be prescribed on the
basis of presenting symptom with consultation of Materia medica. All
medicines and sundry will be procured from a Good Manufacturing Practice
(GMP)-certified firm. Provision will be kept to change the medicines or
potencies and adjust the dosage in subsequent visits whenever required
following Non-pharmacological approaches the principles of classical homoeopathy and such instances will be
compared between groups.And the concomintant cares are the ESPGHAN/NASPGHAN
guidelines suggest ensuring normal fiber and fluid intake, along with regular
physical activity, combined with education to clarify the condition. For children
with a developmental age of at least 4 years, toilet training is also included in
the treatment. Its important to educate both patients and parents about the
underlying mechanisms of FC and the related issue of fecal incontinence. Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 5-15 years
2. Patients suffering from functional constipation (ICD10- K59.00) must fulfill the Rome IV criteria (must include 2 or more of the following, occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome).
3. Patients who can read and/or understand either Hindi or English or Bengali |
|
| ExclusionCriteria |
| Details |
1. Not providing with written informed consent and assent form of participation.
2. Patients using any medications that could cause constipation.
3. Patients with IBS
4. Patients having any previous diagnosis/symptoms suggestive serious gastrointestinal disease.
5. Major psychiatric disorder.
6. Cases with red flag signs pertaining to organic disease
7. Significant chronic health conditions requiring speciality care.
8. Diagnosed cases of other systemic disease affecting quality of life.
9. Patients under other medications for any chronic disease.
10. Simultaneous participation in any other clinical trials
11. Self-reported immune-compromised state, AIDS, hepatitis etc.
12. Undergoing homoeopathic treatment for any chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Paediatric Functional Constipation Questionnaire - Parent version
Form (PedFCQuest-PR) |
Baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric quality of life inventory TM (PedsQL) questionnaire |
Baseline, and every month, up to 3 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) questionnaire |
Baseline, and every month, up to 3 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abdulkarim13068@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Functional constipation (FC) is recognized as a significant health issue in children, highlighting the need for early screening and detection. It is recognized as the most common functional gastrointestinal disease in children, where global prevalence is 14.4%. In Asia the prevalence rate is estimated between 5% and 29.6%. And in India the prevalence rate is 17.1%. Homoeopathy is a frequently used therapy to treat functional constipation; however, the research evidence is limited. This 3 months, double-blind, randomized, placebo controlled pilot trial is aimed to explore the feasibility of a definitive future trial and to evaluate whether IHMs can produce significant effects different from placebo in the treatment of functional constipation in 60 children’s. The primary outcomes measure is PaedFCQuest-PR score and secondary outcomes measure are PedsQL, MYMOP-2 questionnaires, all assured at baseline, and every month up to 3 months. The study being pilot in nature and no hypothesis is being tested, no inferential statistics test will be applied. Group differences will be presented using descriptive statistics: means and confidence intervals (CI). Results will be published in scientific journals. |