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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  
Name  Address 
None  NA 
 
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  
Status 
Not Applicable 
 
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.

 
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