| CTRI Number |
CTRI/2025/02/079853 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF HOMOEOPATHIC MEDICINES IN CHRONIC RHINOSINUSITIS |
|
Scientific Title of Study
|
A RANDOMISED COMPARATIVE STUDY TO COMPARE THE EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN CENTESIMAL VERSUS FIFTY MILLESIMAL SCALE IN THE MANAGEMENT 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 Aruma Prakash |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Nehru Homoeopathic Medical College and Hospital,B block,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
7902910271 |
| Fax |
|
| Email |
arumaprakashvellur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Chowdhry |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Nehru Homoeopathic Medical College and Hospital,B-block ,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
9818366119 |
| Fax |
|
| Email |
rashmichowdhry62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruma Prakash |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Nehru Homoeopathic Medical College and Hospital,B block,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
7902910271 |
| Fax |
|
| Email |
arumaprakashvellur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no:5,Out Patient Department of Nehru Homoeopathic Medical College and Hospital B block,Defence Colony,New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Dr Aruma Prakash |
| Address |
Nehru Homoeopathic Medical College and Hospital B-block, Defence Colony,New Delhi -110024 |
| 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 Aruma Prakash |
Nehru Homoeopathic Medical College and Hospital |
OPD no:5,Nehru Homoeopathic Medical College and Hospital, B-block, Defence Colony, New Delhi,110024
South
DELHI |
7902910271
arumaprakashvellur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee |
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 |
| Comparator Agent |
Individualised Homoeopathic Medicine |
Medicine should be given in Fifty Millesimal scale.Mode of administration is oral.Duration of intervention is 1 year.Dose should be given 4-6 globules.Potency and repetition of medicine should be depends on severity of symptoms and susceptibility of patient
|
| Intervention |
Individualised Homoeopathic Medicine |
Medicine should be given in Centesimal.Mode of administration is oral.Duration of intervention is 1 year.Dose should be given 4-6 globules Potency and repetition of medicine depends upon severity of symptoms and susceptibility of patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to provide written informed consent.
2.Patients of both sexes in age groups between 18-70 years.
3.Patients having chronic sinusitis since 12weeks or more
4.Patients who have not taken any treatment since last 2wks for chronic sinusitis.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from other uncontrolled systemic diseases like cancer, uncontrolled infections or any vital organ failures.
2.Patients suffering from chronic sinusitis complications
3.Psychiatrically unstable patients.
4.Pregnant or lactating females.
5.Immunocompromised patients.
6.Significant renal impairment
7.Severe deviated nasal septum,patients having severe anatomical abnormalities of nose
8.Patients who are terminally ill, under immunosuppressive treatment or self reported immunocompromised state.
9.Diagnosed case of mental illness/psychiatric/life threatening illness affecting quality of life/any organ failure.
10.Substance abuse and/or dependance
11.Patients who are unwilling to take part or not giving consent to join the study or unable to read patient information
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of treatment will be assessed by considering symptomatic improvement of the patient and X ray before and after treatment |
One at baseline,in 6 months and in the end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Will be assessed using Chronic Sinusitis Assesment Score |
Assess at an interval of one month till completion of study |
|
|
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 |
|
Date of First Enrollment (India)
|
13/02/2025 |
| 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
|
It is a Randomised Comparative study to compare the effectiveness of Centesimal and fifty millesimal scale in management of chronic rhinosinusitis. Following obtaining consent on basis of selection criteria,minimum 60 patients will be included in the study.Following that baseline outcome data(rhinosinusitis symptoms, x ray findings,complete case taking)will be done on appropriate randomized procedure to receive individualized Homoeopathic medicine either in centennial or fifty millennial Potency in 1:1 ratio. |