| CTRI Number |
CTRI/2025/09/094569 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathy in the Management of Allergic Rhinitis |
|
Scientific Title of Study
|
A Single-Blind Randomized Controlled Trial To Evaluate The Efficacy Of Individualized Homoeopathic Medicines Versus Ambrosia Artemisiifolia In Centesimal Scale For The Management 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 Parthkumar Patel |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homeopathic Medical College and Hospital |
| Address |
Department of Practice of medicine , Nehru Homoeopathic Medical College and Hospital
Block B, Defence Colony, New Delhi
South
DELHI
110024
India |
| Phone |
9624845345 |
| Fax |
|
| Email |
parthpatel4740@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
Professor, HOD (Practice of Medicine) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital
Block B, Defence Colony, New Delhi
New Delhi
DELHI
110024
India |
| Phone |
8851006347 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthkumar Patel |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homeopathic Medical College and Hospital |
| Address |
Department of Practice of medicine , Nehru Homoeopathic Medical College and Hospital
Block B, Defence Colony, New Delhi
New Delhi
DELHI
110024
India |
| Phone |
9624845345 |
| Fax |
|
| Email |
parthpatel4740@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024. |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B-Block,Defence Colony,New Delhi-110024 |
| Type of Sponsor |
Government 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 Parthkumar Patel |
Nehru Homoeopathic Medical College and Hospital |
Department of Practice of medicine , Nehru Homoeopathic Medical College and Hospital
,Block B, Defence Colony, New Delhi 110024
New Delhi
DELHI |
9624845345
parthpatel4740@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: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambrosia Artemisiifolia in Centesimal Potency |
The Comparator arm will consist of patients randomized to receive Ambrosia Artemisiifolia in centesimal potency.This remedy is one of the most commonly indicated medicines for allergic rhinitis in homeopathy.It is used here as a standardized control intervention against individualized prescriptions.The potency and repetition will be decided as per patientss symptoms severity,susceptibility.Each dose will be consist of 4 medicated globules administered orally.Follow ups will be scheduled every 2 weeks or as per need of the case.Duration of Study 1 Year |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicines will be prescribed based on detailed case taking, symptom totality formation, and repertorization using appropriate repertories. A single remedy will be selected according to homoeopathic principles and administered in the centesimal scale. Potency and repetition will be individualized depending on the patient symptom severity susceptibility. Each dose will consist of 4 medicated globules administered orally, either as a single or repeated dose according to clinical response. Follow-ups will be scheduled every 2 weeks or as per the need of the case.
Duration of Study 1 Year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical signs and symptoms of Allergic Rhinitis as per ICD 10 classification J30.4.
2.Pre diagnosed cases of Allergic Rhinitis.
3.Patients who have not taken any treatment since last 1 week for Allergic Rhinitis .
4.Patients of 18 - 65 years(11).
5.Both sexes.
6.Patients willing to take homoeopathic treatment
7.Patients giving informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known systemic illnesses.
2.Patients with other atopic conditions like allergic asthma, Nasal polyp, Deviated Nasal Septum and urticaria.
3.Age group below 18 years and above 65 years.
4.Patients with parasitic infections or any malignancies.
5.Pregnant women and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Allergic Rhinitis Symptom Score |
ARSS will be evaluated at baseline and at 12 weeks interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absolute Eosinophil Count |
At Baseline and after 12 weeks of intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="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
|
This study is a prospective, single-blind, randomized controlled trial being conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi, to evaluate the efficacy of individualized homoeopathic medicines in comparison with Ambrosia artemisiifolia in centesimal potency for the management of allergic rhinitis. A total of 60 patients, aged between 18 and 65 years, clinically diagnosed with allergic rhinitis (ICD-10 J30.4), will be recruited from the outpatient department and randomly allocated in a 1:1 ratio into two groups. Group A will receive individualized homoeopathic medicines prescribed on the basis of detailed case taking and repertorization, while Group B will be given Ambrosia artemisiifolia in centesimal potency, with dosage and repetition determined by patient susceptibility and symptom severity. The study duration will be one year, including nine months for recruitment and six months for follow-up. The primary outcome measure will be the change in Allergic Rhinitis Symptom Score (ARSS), while the secondary outcome will be the change in Absolute Eosinophil Count (AEC) before and after treatment. Data will be analyzed using appropriate statistical methods with p < 0.05 considered significant, following the intention-to-treat principle. Ethical clearance has been obtained, CTRI registration is in place, and all participants will provide informed consent, with strict adherence to confidentiality and pharmacovigilance measures. |