| CTRI Number |
CTRI/2024/04/066131 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| 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 cases of Chronic Rhinosinusitis |
|
Scientific Title of Study
|
A comparative study to assess the effectiveness of homoeopathic medicines selected on the basis of totality of symptoms vis-Ã -vis pathological simile in cases of chronic rhinosinusitis using SNOT-22 scale |
| 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 Namrata Singh Kushwaha |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7726955741 |
| Fax |
|
| Email |
namrata.kushwaha26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S N Sharma |
| Designation |
Associate Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414320633 |
| Fax |
|
| Email |
raghavdrsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Singh Kushwaha |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7726955741 |
| Fax |
|
| Email |
namrata.kushwaha26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur
Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur
Rajasthan 302029 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Singh Kushwaha |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department Of Organon Of Medicine Opd Room No 2 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
7726955741
namrata.kushwaha26@gmail.com |
| Dr Namrata Singh Kushwaha |
Dr Madan Pratap Khunteta Homoeopathic Medical College Hospital and Research Centre |
Department Of Organon Of Medicine Opd Room No 1 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Vanasthali Marg Station Road Jaipur Rajasthan 302006
Jaipur
RAJASTHAN |
7726955741
namrata.kushwaha26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J328||Other chronic sinusitis, (2) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic Medicine Selected On The Basis Of Pathological Simile According To Richard Hughes |
Homoeopathic Medicines Shall Be Given Orally In Centesimal Potency As Per Case And Hahnemannian Guidelines Given In The 5th Edition Of Organon Of Medicine In The Form Of Globule No 40 Dose And Repetition As Per Need Of Case and reassessment at the end of 3 month |
| Intervention |
Homoeopathic Medicine Selected On The Basis Of Totality Of Symptoms |
Homoeopathic Medicines Shall Be Given Orally In Centesimal Potency As Per Case And Hahnemannian Guidelines Given In The 5th Edition Of Organon Of Medicine In The Form Of Globule No 40 Dose And Repetition As Per Need Of Case and reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving voluntary consent for the study
Cases of chronic rhinosinusitis ICD-10 CODE J32.8, J32.9 criteria
Presence of three or more major clinical symptoms of CRS
Purulent nasal discharge
Nasal congestion or obstruction causing difficulty in breathing from one or both nasal passages or causes mouth breathing
Facial congestion or fullness
Facial or Dental Pain aching pressure-like pain
Hyposmia or anosmia
Headache
Ear Pain
Halitosis
Cough
Fatigue and Dizziness
Fever
Pre diagnosed cases of chronic rhinosinusitis who are under modern medicine treatment but have no relief and seeking homoeopathic treatment |
|
| ExclusionCriteria |
| Details |
Cases with severe systemic disorder with advanced pathological conditions such as severe renal or hepatic disease HIV Autoimmune disease
Patients with complications associated especially with emergency conditions of chronic rhinosinusitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the score obtained (pre and post treatment and post post treatment) from the Sino Nasal Outcome test 22 scale |
Pre score will be taken at baseline of treatment and post score will assessed at the end of study that is 12 weeks using the Sino Nasal Outcome test 22 scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study is expected to show effectiveness of homoeopathic medicines selected on the basis of totality of symptoms in cases of Chronic Rhinosinusitis
|
12 Months |
| The study is expected to show effectiveness of homoeopathic medicines selected on the basis of pathological simile in cases of Chronic Rhinosinusitis |
12 Months |
| This study will help to compare the two methods; Totality of symptoms and pathological simile in the selection of medicine in cases of Chronic Rhinosinusitis |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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 Yet Recruiting |
| 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
|
Aim: To compare the effectiveness of homoeopathic medicines in cases of chronic rhinosinusitis
on the basis of totality of symptoms vis-Ã -vis pathological simile. Objectives: To compare the effectiveness of homoeopathic medicines in cases of chronic rhinosinusitis on the
basis of totality of symptoms vis-Ã -vis pathological simile using using pre and post SNOT-22
scale. To evaluate the effectiveness of homoeopathic medicines selected on the basis of Totality of
symptoms in providing relief in cases of chronic rhinosinusitis using pre and post SNOT-22 scale. To evaluate the effectiveness of homoeopathic medicines in providing relief selected on the basis
of ‘Pathological simile’ in cases of chronic rhinosinusitis using pre and post SNOT-22 scale. To assess the predominant miasm in the cases of chronic rhinosinusitis. |