| CTRI Number |
CTRI/2024/09/073169 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of homoeopathic medicines in chronic sinusitis. |
|
Scientific Title of Study
|
An open label non randomised study on the usefulness of individualised homoeopathic medicines in LM potencies vis-a-vis centesimal potencies in the treatment of chronic rhinosinusitis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shirin Fabi M |
| Designation |
PG Scholar |
| Affiliation |
Govt. Homoeopathic Medical College Kozhikode |
| Address |
Post graduate scholar
Homeopathic philosophy
Department of organon of medicine
Govt. Homoeopathic Medical College
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
8592071038 |
| Fax |
|
| Email |
Shirinfabibhms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rithesh B |
| Designation |
Professor |
| Affiliation |
Kerala University of Health Science |
| Address |
Professor & HOD
Homeopathic philosophy
Department of organon of medicine
Govt. Homoeopathic Medical College
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9400111908 |
| Fax |
|
| Email |
ritheshb.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirin Fabi M |
| Designation |
PG Scholar |
| Affiliation |
Govt. Homoeopathic Medical College Kozhikode |
| Address |
Post graduate scholar
Homeopathic philosophy
Department of organon of medicine
Govt. Homoeopathic Medical College
Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
8592071038 |
| Fax |
|
| Email |
Shirinfabibhms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College, Kozhikode,Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Shirin Fabi M |
| Address |
Post Graduate Scholar Department of Organon of Medicine Govt. Homoeopathic Medical College Karaparamb Kozhikode 673010 |
| 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 Shirin Fabi M |
Government Homoeopathic Medical College Karaparamb Kozhikode |
Research OP
Department OP Room Number 9 Government Homoeopathic Medical College Karaparamba.p.o,Kozhikode, Kerala
Kozhikode
KERALA |
8592071038
shirinfabibhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Homoeopathic Medical College, Kozhikode, Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
constitutional homoeopathic medicine in centesimal potency. |
constitutional homoeopathic medicine 1 dose in centesimal potency taken orally and repeated according to homoeopathic principles and reviewed after 2 weeks. |
| Comparator Agent |
constitutional homoeopathic medicine in LM potency. |
1 dose of constitutional homoeopathic medicine in LM potency taken orally and repeated according to homoeopathic principles and reviewed after 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cases that fulfil the diagnostic criteria.
Cases that have a SNOT score above seven. |
|
| ExclusionCriteria |
| Details |
Cases with other serious associated illness and life threatening conditions like
malignancy.
Cases which had undergone surgery for sinusitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of treatment will be assessed by the SNOT 22 scoring system. |
The outcome of treatment will be assessed by the SNOT 22 scoring system at the beginning of treatment and after 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of usefulness of constitutional homoeopathic medicine in centesimal potency over LM potency. |
After 1 year (after completion of study). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
07/09/2024 |
| 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 study is an open label non randomised study on the usefulness of individualised homoeopathic medicines in LM potencies vis-a-vis centesimal potencies in chronic rhinosinusitis. Diagnosis of the case will be done by taking a plain xray of paranasal sinuses. Homoeopathic medicines are prescribed according to homoeopathic principles and reviewed every 2 weeks for 4 months. Outcome of treatment will be assessed by SNOT 22 scoring system. |