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CTRI Number  CTRI/2021/12/038881 [Registered on: 23/12/2021] Trial Registered Prospectively
Last Modified On: 23/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of common cold in children 
Scientific Title of Study   Individualized homeopathic medicines in upper respiratory tract infections in children: Double-blind, randomized, placebo-controlled pilot trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1272-6138  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangita Saha 
Designation  Professor 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Organon of Medicine and Homeopathic Philosophy, OPD room no. 4 and 10; 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433849505  
Fax    
Email  dr.sangita78@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sangita Saha 
Designation  Professor 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept. of Organon of Medicine and Homeopathic Philosophy, OPD room no. 4 and 10; 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9433849505  
Fax    
Email  dr.sangita78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tarikul Mondal 
Designation  Undergraduate Trainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital 
Address  Dept. of Pediatrics, OPD room no. 4, 12, Gobinda Khatick Road, Tangra, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  8116184771  
Fax    
Email  tarikulofficial143@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sangita Saha  D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal  Dept. of Pediatrics and Dept. of Organon of Medicine, Room no. 4 and 10; 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 9433849505

dr.sangita78@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 
Comparator Agent  Identical-looking placebo  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. Patients will be advised to refrain from handling the globules or from eating, drinking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. Adequate fluid and fruits intake will be advised. Route of administration: Per oral. Duration of therapy: 15 days. 
Intervention  Individualized homeopathic medicines in centesimal potencies  Intervention is planned as administering individualized homeopathic medicines in centesimal potencies. Each dose will 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 or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. Adequate fluid and fruits intake will be advised. Route of administration: Per oral. Duration of therapy: 15 days. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1. Clinical signs and symptoms of an upper respiratory tract infections with a duration of greater than or equal to 24 hours with or without fever greater than or equal to 37.5 degree Celsius.
2. At least 1 of 3 types of upper respiratory tract infections symptoms – nasal (plugged nose, runny nose, sneezing), pharyngeal (scratchy throat, sore throat, pharyngeal hyperemia),
and cough (ordinary cough without suspicion of acute lower respiratory tract disease).
3. At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active.
4. Literate guardians or attendants capable of understanding and filling the questionnaire and providing written informed consent. 
 
ExclusionCriteria 
Details  1. Severe or complicated course of upper respiratory tract infections.
2. Signs of acute lower respiratory tract infections.
3. COVID-19 positive cases.
4. Current symptoms mainly induced by other acute ear, nose, throat diseases.
5. Daily use of antibiotics, steroids and cytotoxic agents.
6. Immune-compromised state.
8. Already undergoing homeopathic or other modes of treatment for upper respiratory tract infections. 
 
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 
Number of patients in each group showing complete disappearance of the symptoms of upper respiratory tract infection.  Baseline and after 4, 8 and 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Wisconsin Upper Respiratory Symptom Survey (WURSS-21)   Baseline and after 4, 8 and 15 days 
Upper respiratory tract infection symptom severity scale (URI-SSS)  Baseline and after 4, 8 and 15 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 
Date of First Enrollment (India)   29/12/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dndeofficial@gmail.com].

  6. For how long will this data be available start date provided 16-07-2022 and end date provided 15-07-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Upper respiratory tract infections (URTI) include various infections affecting the different parts of upper respiratory tract (URT) extending from nose to vocal cords and mainly include acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media. In developing countries, on an average, every child has 6.8 to 8.8 episodes of acute respiratory tract infections (ARTI) per year. In India, the number is 0.37 episodes per child-year. Morbidity accounts for  60-80% of time lost from school by children. Apart from impairing the quality of life, economic burden by the cost of treatment and the number of absentees from work by parents for their children is a major problem. Homeopathic treatment is regarded as a possible option for URTI. However, the research evidence remains compromised.  In this double-blind, randomized, placebo-controlled pilot trial of individualized homeopathic medicines in treatment of URTI at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from ARTI will be randomized to receive either individualized homeopathic medicines or identical-looking placebo for a period of 15 days. The number of children showing complete disappearance of ARTI symptoms, Wisconsin Upper Respiratory Symptom Survey (WURSS-21) and Upper Respiratory Tract Infection symptom severity scale (URI-SSS) will be assessed at baseline and after 4, 8 and 15 days of intervention. Adequate fluid and fruit intake will be advised to all the enrolled children. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
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