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CTRI Number  CTRI/2020/10/028585 [Registered on: 23/10/2020] Trial Registered Prospectively
Last Modified On: 29/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic treatment of chronic tonsillitis in adults 
Scientific Title of Study   Individualized homoeopathic medicines in treatment of chronic tonsillitis in adults: Randomized, double-blind, placebo-controlled, pilot trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1259-4745  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Sarkar 
Designation  Postgraduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Materia Medica; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala

Haora
WEST BENGAL
711104
India 
Phone  9804120328  
Fax    
Email  ashish.dtk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Madhabananda Saha 
Designation  Principal 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Materia Medica; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala

Haora
WEST BENGAL
711104
India 
Phone  9434230785  
Fax    
Email  principalmbhmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Shubhamoy Ghosh 
Designation  Professor and Head 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Pathology and Microbiology; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala

Haora
WEST BENGAL
711104
India 
Phone  9831034229  
Fax    
Email  shubhamoy67@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala, Howrah 711104, West Bengal 
 
Primary Sponsor  
Name  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala, Howrah 711104, West Bengal 
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 
Ashish Sarkar  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Department of Homoeopathic Materia Medica; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala, Howrah 711104, West Bengal
Haora
WEST BENGAL 
9804120328

ashish.dtk@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: J350||Chronic tonsillitis and adenoiditis,  
 
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 4 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Patients will be given advices to gurgle with 100 ml saline luke warm water twice a day and acute homoeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. Food and drink containing vitamin C will be encouraged. Route of administration of medicine: Oral. Duration of therapy: 3 months. 
Comparator Agent  Placebo  This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 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. Patients will be given advices to gurgle with 100 ml saline luke warm water twice a day and acute homoeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, glucocorticosteroids and antiallergics will not be permitted. Food and drink containing vitamin C will be encouraged. Route of administration of medicine: Oral. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Three or more episodes of acute tonsillitis per year since last 2 years or patients with clinical sign and symptoms of chronic tonsillitis (ICD-10-CM Diagnosis Code J35.01)
2. Patients of either sex
3. Age range 18-65 years
4. Literate patients; ability to read and write in Bengali and/or English
5. Patients providing written informed consent 
 
ExclusionCriteria 
Details  1. Presence of peritonsillar abscess or acute or chronic respiratory disease, occlusion of pharynx due to enlargement of tonsils
2. Severe co-morbidity including previous malignant disease during the past 5 years prior to enrolment
3. Previous surgery in the past 6 month or need for surgery of the nose, para-nasal sinuses, adenoid of tonsils.
4. Presence of neurological or psychiatric diseases affecting quality of life
5. Cases already undergoing homoeopathic treatment for any chronic diseases since last 6 months
6. Treatment with systemic antibiotics, gluco-corticoids or immune modulators during the week prior to inclusion
7. Substance abuse and/or dependence
8. Pregnant, puerperial and lactating women
9. Self-reported immune-compromised state 
 
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 
Visual analogue scale (VAS) scores of sore throat pain model (STPM)  At baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Tonsil and adenoid health status instrument (TAHSI) scores  At baseline, every month, up to 3 months 
Glasgow benefit inventory (GBI) scale  Every month up to 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/10/2020 
Date of Study Completion (India) 29/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet; to be published 
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

  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 [ashish.dtk@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2029?
    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
Modification(s)  

The patient’s quality of life is significantly negatively impacted by chronic tonsillitis. Chronic tonsillitis is said to benefit from homeopathic medicines, however there is currently inadequate evidence to support this claim. We evaluated the efficacy of individualized homeopathic medicines (IHMs) in treating chronic tonsillitis in adults in comparison with placebos. In this 3-month, double-blind, randomized (1:1), placebo-controlled trial, 60 adult patients with chronic tonsillitis were randomized to receive either IHMs or identical-looking placebos. Conventional management was advised concurrently to all individuals. The primary outcome was disease severity using the visual analogue scale (VAS) scores of sore throat pain model (STPM) comprising of the sore throat pain intensity VAS (STPIS-VAS), difficulty swallowing scale VAS (DSS-VAS), and swollen throat scale VAS (SWOTS-VAS); secondary outcomes were the Tonsil and adenoid health status instrument (TAHSI) scores and Glasgow benefit inventory (GBI) scale – all measured at baseline, and every month, up to 3 months. Group differences were calculated on the intention-to-treat sample using unpaired t-tests primarily, and two-ways repeated measure analysis of variance secondarily. After 3 months of intervention, inter-group differences became statistically significant favoring IHMs against placebos on STPIS-VAS (mean difference: -1.2, 95% CI -1.8 to -0.7, P < 0.001, d = 1.142), DSS-VAS (mean difference: -1.3, 95% CI -1.9 to -0.7, P < 0.001, d = 1.129), and SWOTS-VAS (mean difference: -1.4, 95% CI -2.0 to -0.8, P < 0.001, d = 1.167). Secondary outcomes also revealed significance favoring homeopathy over placebo after 3 months – TAHSI (mean difference: -13.1, 95% CI -20.3 to -5.9, P < 0.001, d = 0.943), and GBI (mean difference: -10.6, 95% CI -16.3 to -4.9, P < 0.001, d = 0.967). TAHSI subscales and GBI subscales also yielded similar significant results. Secondary analyses failed to demonstrate any significant effect on the primary outcome, but showed significance on the secondary outcomes and in most of the subscales. Thus, IHMs considerably outperformed placebos in the treatment of adult patients with chronic tonsillitis.

 
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