| CTRI Number |
CTRI/2025/09/095044 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Research on the potential benefits of homeopathic remedies for adults (18–40 years old) suffering from allergic rhinitis to lessen symptoms and the need for conventional allopathic medications. |
|
Scientific Title of Study
|
EFFICACY OF INDIVIDUALIZD HOMOEOPATHIC MEDICINE SELECTED USING COMPLETE REPERTORY IN MANAGEMENT OF ALLERGIC RHINITIS USING TNSS AND RQLQ SCALE- A RANDOMIZED SINGLE BLIND CONTROLLED TRIAL |
| 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 Surendra Kumar |
| Designation |
Associate PRofessor |
| Affiliation |
Nootan Homoeopathic Medical College and Hospital |
| Address |
Associate Professor Dept of Repertory 2nd Floor Nootan Homoeopathic Medical College Hospital
Sakalchand Patel University Campus Visnagar Gujarat India
Pin No 384315
Mahesana
GUJARAT
384315
India |
| Phone |
9462216191 |
| Fax |
|
| Email |
drbamniyasuren@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Bidwalkar |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre Jaipur |
| Address |
Professor Dept of Repertory Dr M P K Homoeopathic Medical College Homoeopathy and Research Cneter Jaipur Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN
302017
India |
| Phone |
9414078227 |
| Fax |
|
| Email |
bidwalkars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirav S Bhatt |
| Designation |
Principal Professor |
| Affiliation |
Nootan Homoeopathic Medical College and Hospital |
| Address |
Principal MS
Pricipal room 1st Floor NOotan Homoeopathic Medical College Hospital Sakalchand Patel University Campus Visnagar Gujarat 384315
Mahesana
GUJARAT
384315
India |
| Phone |
9427861254 |
| Fax |
|
| Email |
nsbhatt410@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nootan Homoeopathic Medical College Hospital saklachand Patel University campus Visnagar Gujarat India
pin no 384315 |
|
|
Primary Sponsor
|
| Name |
Dr Surendra Kumar |
| Address |
Associate Professor Dept of Repertory 2nd Floor Nootan Homoeopathic Medical College Hospital Sakalchand Patel University Campus Visnagar Gujarat Pin no 384315 |
| 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 Surendra Kumar |
Nootan Homoeopathic Medical College Hospital |
Ambaji road Sakalchand patel university Campus Visnagar Gujarat 384315
Mahesana
GUJARAT |
9462216191
drbamniyasuren@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homoeopathy University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine and conventional medicine |
one group is the interventional group, which is givne Individual homoeopathic medicine selected by repertorization using the complete repertory, which will be obtained through proper case taking and conventional medicine
(levocetirizine + montelukast)that he/she is already taking. |
| Comparator Agent |
Homoeopathic Placebo and Conventional Medicine |
comparator group is the placebo group,placebo is non active homoeopathic medicine pilles, which does not affect the effect of regular medicine. And conventional medicine (levocetirizine +montelukast) that he/she already taking Levocetirizine + Montelukast |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient of 18-40 yrs. old age groups, of both sexes, irrespective of their socioeconomic status.
Baseline TNSS score more then 05
Patient took allopathic medicine for Allergic Rhinitis.
Willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant & lactating mothers will not be included.
Patient with other chronic disease requiring ongoing medication.
patients who had a history of chronic nasal or upper respiratory tract symptoms or disorders other than AR
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measured pre and post (Before and After) change in the TNSS total nasal symptoms score from baseline or starting of study to 12 months period |
12 months period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the RQLQ rhino-conjunctivitis Quality of life Questionnaires score from baseline or starting of study to 06 months of period.
•Reduce the need of conventional therapy medicine- pre and post of treatment confirming by conventional therapist.
|
12 months period |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
01/10/2025 |
| 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="6"
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
|
A prospective study of 136 randomly selected patients of Allergic Rhinitis from the college outdoor patient department to whom, homoeopathic medicinal intervention will be done by detailed case taking, analysis & prescription to study the efficacy of homoeopathic medicines in such cases simultaneously ascertaining the efficacy of individualized Homoeopathic Medicine Selected Using Complete Repertory. |