| CTRI Number |
CTRI/2020/12/029683 [Registered on: 09/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Upper Respiratory Tract Infection in Children |
|
Scientific Title of Study
|
Individualized Homoeopathic Medicines in the Treatment of Upper Respiratory Tract Infections in Children Using Kent’s Repertory: A Double-blind, Randomized, Placebo controlled
Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Biswas |
| Designation |
Postgraduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Repertory, OPD no. 9, Drainage Canal Road, Doomurjala
Haora
WEST BENGAL
711104
India |
| Phone |
7547973993 |
| Fax |
|
| Email |
bikash21592@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Pathology &Microbiology, OPD no. 1, Drainage Canal Road, Doomurjala
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College &Hospital |
| Address |
Department of Pathology &Microbiology, OPD no. 1, Drainage Canal Road, Doomurjala
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College &Hospital, Govt. of West Bengal |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage canal road, Doomurjala, Howrah, West Bengal, PIN-711104 |
| 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 |
| Bikash Biswas |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Repertory, OPD no. 9, Drainage Canal Road, Doomurjala
Haora
WEST BENGAL |
7547973993
bikash21592@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J06||Acute upper respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies. Each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 14 days. |
| Comparator Agent |
Placebo |
This arm will be administered an identical looking placebo, indistinguishable from verum. Each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 14 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Willingness and consent of the parents or immediate caregivers for inclusion in this study
2. Clinical signs and symptoms of a URTI with a duration of up to 24hours accompanied with or without fever ≥37.5ᵒC (axillary body temperature)
3. At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease).
4. At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active
|
|
| ExclusionCriteria |
| Details |
1. Severe or complicated course of URTI.
2. Persistent fever more than 1020F
3. Signs of acute lower respiratory tract disease.
4. Current symptoms mainly induced by other acute ENT diseases.
5. Daily use of antibiotics, steroids and cytotoxic agents.
6. Children on active treatment from any other system of medicine.
7. Children with any uncontrolled systemic disease, infection, and any organ failure.
8. Severe co morbidity including previous malignant disease during the past 5year prior enrolment.
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS-18) |
Baseline, 3 days, 7 days, 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptom Score for RTI |
Baseline, 3 days, 7 days, 14 days |
| Time taken for complete resolution of symptoms |
Counted in days |
| Adverse events (persistent fever, additional medication, spread of infections etc.) |
Event record |
|
|
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)
|
15/12/2020 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Upper respiratory tract infection includes any infection above the vocal cord. Infections affecting the different parts of the upper respiratory tract which mainly includes acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media. Children are more prone to suffer from this problem. Homoeopathic physicians treat thousands of patients belongs to such age group. Few clinical trials were conducted and showed some positive results. However, trials with individualised homoeopathy are scarce. We aim to evaluate the effect of Individualised Homoeopathic treatment in pediatric URTI and also looking at the feasibility of further similar trials. The result of the study expected to help us deciding many facets of the Individualised homoeopathic treatment in such cases and designing future studies. |