| CTRI Number |
CTRI/2020/10/028743 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| 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 respiratory tract infection in children |
|
Scientific Title of Study
|
Feasibility testing of a double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in pediatric upper respiratory tract infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1259-7168 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agnik Karmakar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 3; 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
8981794866 |
| Fax |
|
| Email |
agnikkarmakarag@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 3; 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
9007263548 |
| Fax |
|
| Email |
ganguly.subhasish@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine, Division 10 (PG 1), 12, Gobinda Khatick Road, Kolkata
Kolkata WEST BENGAL 700046 India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 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 |
| Agnik Karmakar |
D. N. De Homoeopathic Medical College and Hospital |
Department of Organon of Medicine and Homoeopathic Philosophy; OPD no. 3; 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 Kolkata WEST BENGAL |
8981794866
agnikkarmakarag@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: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 2 globules (no. 30) 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. Medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration of medicine: Oral. Duration of therapy: 15 days. |
| Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 2 globules (no. 30) 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. Medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. Route of administration of medicine: Oral. Duration of therapy: 15 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group 1-11 years and of either sex
2. Clinical signs and symptoms of an URTI with a duration of ≥ 24 hours with or without fever ≥37.5ᵒC
3. At least 1 of 3 types of URTI symptoms – nasal (plugged nose, runny nose, sneezing), pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), and 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.
5. Literate guardians or attendants capable of understanding and filling the questionnaire and providing written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Severe or complicated course of URTI
2. Signs of acute LRTI
3. COVID-19 positive cases as diagnosed by RT-PCR method
4. Current symptoms mainly induced by other acute ENT diseases
5. Daily use of antibiotics, steroids and cytotoxic agents
6. Diagnosed cases of unstable developmental, mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
7. Immune-compromised state, and
8. Already undergoing homoeopathic or other modes of treatment for URTI. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wisconsin Upper Respiratory Symptom Survey (WURSS-21) scores |
At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire scores |
At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days |
| URI symptom severity scale (URI-SSS) scores |
At baseline, 4th (±1) day, 8th (±1) day, and 15th (±2) days |
|
|
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)
|
31/10/2020 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published later |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Respiratory tract diseases are common human ailments with which people, especially children, are brought to health facilities. Upper respiratory tract infection (URTI) mainly includes rhinitis, nasopharyngitis, acute sinusitis, tonsillitis, otitis media, acute mastoiditis, laryngotracheobronchitis (croup), acute epiglottitis and diphtheria. In developing countries, on an average, every child has 6.8 to 8.8 episodes of URTI per year, accounting for 30 to 50% of the total paediatric outpatient visits and 20-30% of the paediatric admissions. Though homoeopathic medicines showed its positive result in URTI, but rigorous clinical trials has scarcity. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from URTI will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical-looking placebo (control; n=30). We aim to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Wisconsin Upper Respiratory Symptom Survey (WURSS-21) scores, Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire scores and URI symptom severity scale (URI-SSS) scores will be used as the primary and econdary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |