| CTRI Number |
CTRI/2020/10/028654 [Registered on: 27/10/2020] 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 chronic sore throat in children |
|
Scientific Title of Study
|
Individualized homoeopathic medicines in chronic tonsillitis of children: Double-blind, randomized, placebo-controlled, pilot trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1259-5069 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandan Tudu |
| 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, West Bengal 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8436446125 |
| Fax |
|
| Email |
marsal.dahar77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyajit Naskar |
| Designation |
Lecturer |
| 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, West Bengal 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8981859153 |
| Fax |
|
| Email |
satya.naskar@gmail.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, WEST BENGAL
700046
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 |
|
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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 |
| Chandan Tudu |
D. N. De Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine and Homoeopathic Philosophy; OPD no. 3; 12, Gobindo Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
8436446125
marsal.dahar77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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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 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. Patients will be given general advices on gurgling 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, gluco-corticosteroids 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: 3 months. |
| 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. Patients will be given general advices on gurgling 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, gluco-corticosteroids and antiallergics will not be permitted. Route of administration: Oral. Duration of therapy: 3 months. |
|
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Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of 8-18 years and of either sex
2. Presenting with clinical signs and symptoms of chronic tonsillitis – presence of any symptoms: hyperaemia of anterior and posterior palatine arches, enlarged submandibular lymph nodes, halitosis, chronic sore throat, foreign body sensation or a history of expelling foul-tasting and foul-smelling cheesy lumps.
3. Children after the washout period of one week ho underwent treatment with antibiotics.
4. Literate parents/guardian; ability to read English / Bengali.
5. Parents giving writing consent to participate. |
|
| ExclusionCriteria |
| Details |
1. Patient with complication of tonsillitis like peritonsillar abscess and parapharyngeal abscess and infection, cor pulomonale.
2. Patient with uncontrolled systemic diseases or infections.
3. Children presenting with craniofacial abnormalities and neurological disorders.
4. Diagnosed or suspected cases of tonsillar malignancy.
5. Substance abuse and/or dependence
6. Immune compromised states |
|
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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 |
| Questionnaire for evaluation of quality of life in children |
At baseline, and every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Paediatric quality of life (PedsQLTM) inventory questionnaire version 4.0 |
At baseline, and every month up to 3 months |
|
|
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)
|
29/10/2020 |
| 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)
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)?
|
|
Brief Summary
|
Tonsillitis refers to the inflammation of the pharyngeal tonsils usually extends to the adenoids and the lingual tonsils. Prevalence of tonsilitis cases are maximum in 6-12 yrs age group (61%), followed by 12-18 yrs age group (20%) and in 4-5 yrs children (10%). Conservative treatment includes antibiotics, and surgery, which is usually performed for recurrent or chronic pharyngotonsillitis. Though a number of patients refer homoeopathy for tonsilitis, but rigorous clinical research data is lacking. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from chronic tonsillitis 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. Questionnaire for evaluation of quality of life in children scores, and PedsQL inventory questionnaire version 4.0 scores will be used as the primary and secondary outcome measures rspectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
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