| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashish.dtk@gmail.com].
- 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.
- 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. |