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CTRI Number  CTRI/2023/03/050305 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 06/03/2023
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 treatment of sore throat in children 
Scientific Title of Study   A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving the symptoms of acute viral tonsillitis in children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1288-7419  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sourav De 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Repertory (OPD no. PG3) and ENT(opd no 7) pediatrics(OPD no 2)12 Gobinda Khatick Road, Tangra, kolkata 46
Dept. of Repertory, OPD no. PG3 and ENT( opd no 7),pediatrics opd(OPD NO 2), 12Gobinda Khatick Road, Tangra, Kolkata 46
Kolkata
WEST BENGAL
700046
India 
Phone  7001571796  
Fax    
Email  sourav.de.201@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shubhamoy Ghosh 
Designation  Professor and Head 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Pathology and Microbiology, Repertory (OPD no. PG3) and ENT (OPD NO. 7), pediatrics(OPD NO 2) Gobinda Khatick Road, Tangra
Dept. of Pathology and Microbiology, Repertory (OPD no. PG3) and ENT (OPD NO. 7), pediatrics(OPD NO 2) Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India 
Phone  9831034229  
Fax    
Email  shubhamoy67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubhamoy Ghosh 
Designation  Professor and Head 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Pathology and Microbiology,Repertory( OPD no. PG3 and ENT(OPD NO 7),pediatrics(OPD NO2) 12, Gobinda Khatick Road, Tangra
Dept. of Pathology and Microbiology, Repertory (OPD no. PG3) and ENT (OPD NO 7 ), pediatrics(OPD NO 2),12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India 
Phone  9831034229  
Fax    
Email  shubhamoy67@gmail.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and 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 
Sourav De  D N De Homoeopathic Medical College and Hospital  OPD no. PG3 and room 2 (Pediatrics), no. 7 (ENT), Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 7001571796

sourav.de.201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J038||Acute tonsillitis due to other specified organisms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos plus concomitant care  This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; doses and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the patients will receive advice on gargling with luke-warm saline water. Appropriate homoeopathic remedy or paracetamol will be used as rescue remedy as appropriate. Duration of the therapy: 15 days. 
Intervention  Individualized homoeopathic medicines in centesimal potencies plus concomitant care  Intervention is planned as administering the indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; doses and repetition depending upon the individual requirement of the cases. Patients will be advised to restrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the patients will receive advice on gargling with luke-warm saline water. Appropriate homoeopathic remedy or paracetamol will be used as rescue remedy as appropriate. Duration of therapy: 15 days. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1.Children suffering from acute sore throat of resent onset (≤ 3 days), representing with clinical features of acute vial tonsillitis, scoring ≥ 5 on tonsillopharyngitis assessment (TPA) and viral aetiology confirmed by RTPCR, and bacterial origin will be excluded by bacterial culture.
2.Participants of either sex.
3.Age between 5 and 15 years.
4.Literate patient’s parents; ability to read and write in Bengali and/or English. Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires.
5.The parents providing written informed consent voluntarily and the children providing with informed assent. 
 
ExclusionCriteria 
Details  1.Causes other than viral.
2.Presence of uncontrolled co-morbidities.
3.Self-reported immune-compromised state.
4.Vulnerable population - unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
5.Simultaneous participation in any other clinical trials.
6.Exclusion of patient with COVID-19 as detected by the rapid antigen detection test. 
 
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 
Tonsillo-pharyngitis assessment (TPA) score  Baseline, every day, up to 7 days, and 10th and 15th days. 
 
Secondary Outcome  
Outcome  TimePoints 
Days to remission of sore throat  Baseline, every day, up to 7 days, and 10th and 15th days. 
Sore throat pain model (STPM)  Baseline, every day, up to 7 days, and 10th and 15th days. 
Days to complete recovery  Baseline, every day, up to 7 days, and 10th and 15th days. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   06/03/2023 
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   None yet; to be published later 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 [sourav.de.201@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    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   Acute viral tonsillitis is one of the commonest types of acute tonsillitis. It commonly affects school-going children of 5 to 15 years of age group and the most commonly produced symptom is sore throat. The aetiology of viral tonsillitis is 70% to 90% of all tonsillitis. Virus causes 70% of sore throats of children in the age groups of 5-16. Although homoeopathic remedies are considered to be useful alternative to conventional therapies, there is paucity of published researches substantiating such claim. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 78 children suffering from acute viral tonsillitis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Tonsillopharyngitis assessment (TPA) (primary outcome), Days to remission of sore throat, Sore throat pain model (STPM), and Days to complete recovery (secondary outcomes), baseline, every day, up to 7 days, and 10th and 15th days. Group differences will be estimated statistically. Results will be published in scientific journals. 
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