| CTRI Number |
CTRI/2024/10/075396 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Individualized Homoeopathic Medicine in the management of Tonsillitis |
|
Scientific Title of Study
|
A Prospective Observational Study To Assess The Role Of Individualized Homoeopathic Medicine In The Management Of Tonsillitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha Nama |
| Designation |
Post graduate student in homoeopathic materia medica |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Department of materia medica, Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
9549524698 |
| Fax |
|
| Email |
pratibhanama96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Yogeshwari gupta |
| Designation |
Principal, HOD ,Department of materia medica ,SKHMC &RC |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Department of Materia medica, Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414229555 |
| Fax |
|
| Email |
Homeopathy@swasthyakalyan.org |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha Nama |
| Designation |
Post graduate student in homoeopathic materia medica |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Department of Materia Medica, Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan 302022
RAJASTHAN
302022
India |
| Phone |
9549524698 |
| Fax |
|
| Email |
pratibhanama96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan, India 302022 |
|
|
Primary Sponsor
|
| Name |
Pratibha nama |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan 302022 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Pratibha nama |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
Department of Materia Medica Swasthya Kalyan Homoeopathic Medical College and Research Centre
10-A, Sitapura Institutional Area, Sitapura Institutional Area, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN |
9549524698
pratibhanama96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homoeopathic medical college institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J03||Acute tonsillitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualized homoeopathic medicine |
M.L. NO: M/728/2016(H)
Individualized Homoeopathic Remedy route of Administration- Orally in form- Globules with potency and dosage according to patient susceptibility and given in single dose and repeated if investigator finds it necessary. Evaluated after 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient coming from other mode of treatment with no relief .
Patient of both sexes are included .
3-50 years age group people are included.
|
|
| ExclusionCriteria |
| Details |
Cases which required emergency treatment.
Pregnant women and lactating mothers will not be included in the study.
Below 3 & Above 50 years age group are excluded.
Cases which need surgical intervention.
Immunocompromised patient such as suffering from HIV, Hepatitis B/C etc.
Cases with multi systemic illness will be excluded from the study and cases with advance pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sore throat assessment tool 10 & 13 before and after treatment for assessing efficacy of individualized homoeopathic medicine in cases of tonsillitis |
baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prepare therapeutic compendium of homoeopathic medicines in the treatment of tonsillitis |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
26/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The title of study is
"a prospective observational study to assess the role of individulized
homoeopathic medicine in the management of tonsillitis" and its objectives
are- 1. To assess the role of individualized homoeopathic medicine in the treatment of tonsillitis. 2. To prepare therapeutic compendium of homoeopathic medicines in the treatment of tonsillitis. At the end of study it is
expected that- 1. The homoeopathic management will be proven beneficial in the treatment of tonsillitis. 2. The study will help to develop and implement strategy in homoeopathic management of tonsillitis. |