| CTRI Number |
CTRI/2025/02/081203 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess whether Natrum Muriaticum helps to relieve watery nose discharge in Allergic Rhinitis. |
|
Scientific Title of Study
|
A prospective study to assess the likelihood ratio for a single rubric nose—discharge, watery of homoeopathic medicine natrum muriaticum from kent’s repertory in cases of allergic rhinitis
|
| 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 Sajal Sharma |
| Designation |
PG Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College
Hospital And Research Centre A Constituent College Of
Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
07073269064 |
| Fax |
|
| Email |
drsajalsharma000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar Kumawat |
| Designation |
Associate Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College
Hospital And Research Centre A Constituent College Of
Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
9785722594 |
| Fax |
|
| Email |
homoeopathytoday@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajal Sharma |
| Designation |
PG Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College
Hospital And Research Centre A Constituent College Of
Homoeopathy University Saipura Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
07073269064 |
| Fax |
|
| Email |
drsajalsharma000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Repertory 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sajal Sharma |
Dr Girendra Pal Homoeopathic Hospital |
Department Of
Repertory OPD Room
No 3 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 |
07073269064
drsajalsharma000@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: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated Homeopathic Medicines |
All the eligible patients having the symptoms of allergic rhinitis with watery nasal discharge will be
prescribed Homeopathic
medicines. Prescription will be
based upon characteristic
symptoms, if similarity is
detected they will be prescribed
Natrium muriaticum. Otherwise
patient will be prescribed other
Homoeopathic medicines as per
the indication. Homoeopathic
Medicine shall be given orally in
any potency as per the
susceptibility of the patient and
Hahnemannian guidelines of
Organon of Medicine in the form
of globules of 40 numbers.
Dose and Repetition as per
need of the case reassessment
at the end of 3 month. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes presenting with ALLERGIC RHINITIS ICD-10 code L30.8 based on clinical history
and physical examination findings.
Diagnosed with allergic rhinitis.
Provide informed consent to participate.
|
|
| ExclusionCriteria |
| Details |
Presence of chronic rhinosinusitis or other nasal disorders.
Concurrent treatments that may interfere with study outcomes.
Pregnant women and lactating women were not included in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to the scores obtained (pre and post treatment) from the Total Nasal Symptom Score (TNSS) and Outcome in Relation to Impact on Daily Living (ORIDL) score.
|
Pre scores will be taken at baseline of treatment and post score will be assessed at the end of 12 weeks using Total Nasal Symptom Score (TNSS) and Outcome in Relation to Impact on Daily Living (ORIDL) score. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the Likelihood Ratio (LR) of Natrum Muriaticum for the rubric "Nose - Discharge, Watery" in cases of allergic rhinitis using TNSS scale.
To observe and evaluate the changes before and after in Outcome in relation to impact on daily living (ORIDL) in patients receiving Natrum Muriaticum over 3 months of treatment. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/03/2025 |
| 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 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
|
LIKELIHOOD RATIO The likelihood ratio is a statistical tool that aids physicians in refining their diagnostic skills across different diseases. Likelihood ratio is based on the concept of Bayes’ theorem which implies that when a symptom is more commonly found in the group responding positively to a specific medicine compared to the rest of the population, the likelihood of a successful cure is higher. It allows physicians to gauge the probability of a medicine’s efficacy based on the presence or absence of particular symptoms, applying the likelihood ratio at a symptom level to enhance prescription accuracy. Implementing likelihood ratios in homeopathy has the potential to enhance the current structure of materia medica and repertory systems |