| CTRI Number |
CTRI/2026/03/105986 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of Homoeopathic Treatment in Patients with Allergic Rhinitis (Allergy-Related Nasal Symptoms) |
|
Scientific Title of Study
|
A Single-Arm Clinical Study to Evaluate the Effectiveness of Individualised Homoeopathic Treatment in Cases of Allergic Rhinitis using Boenninghausen’s Characteristics & Repertory by C.M. Boger |
| 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 Sahiba Sadaf |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Delhi |
| Address |
OPD number 125, Department of Repertory,National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela
North
DELHI
110040
India |
| Phone |
9315614139 |
| Fax |
|
| Email |
sahibasadaf897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy, Delhi |
| Address |
OPD number 125, Department of Repertory,National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela
North
DELHI
110040
India |
| Phone |
9681134030 |
| Fax |
|
| Email |
jitendra.nih@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahiba Sadaf |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Delhi |
| Address |
OPD number 125, Department of Repertory,National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela
North
DELHI
110040
India |
| Phone |
9315614139 |
| Fax |
|
| Email |
sahibasadaf897@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela, Delhi 110040 India |
|
|
Primary Sponsor
|
| Name |
Dr Sahiba Sadaf |
| Address |
OPD number 125, Department of Repertory, National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela, Delhi 110040, India |
| 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 Sahiba Sadaf |
National Institute of Homoeopathy, Delhi |
OPD number 125, Department of Repertory,National Institute of Homoeopathy, Sector A 8, Ramdev Chowk, Narela
North
DELHI |
9315614139
sahibasadaf897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Homoeopathy, Delhi |
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 |
Individualised Homoeopathic medicine |
Participants will receive individualized homoeopathic treatment based on classical homoeopathic principles. The potency, dose, and repetition of the medicine will be decided according to the individual patient’s symptomatology and response to treatment. Patients will be followed up at regular intervals for a period of 3 months, during which necessary adjustments in the prescription may be made as per clinical response. All the medicines will be administered orally for 3 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients clinically diagnosed with Allergic Rhinitis, presenting with characteristic symptoms such as sneezing, nasal obstruction, rhinorrhoea, and nasal itching.
2.Patients of either sex aged between 18–60 years.
3.Cases meeting the ARIA classification for Allergic rhinitis.
4.Patients having a baseline TNSS between 5 and 15.
5.Participants must be able to give informed consent, meaning they understand the nature of the study or treatment and agree to participate voluntarily.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.Patients with severe systemic illnesses such as uncontrolled diabetes, cardiovascular disorders, chronic kidney disease, or hepatic impairment.
3.Patients with other chronic respiratory conditions such as asthma, chronic sinusitis, rhinosporidiosis or COPD that may confound the assessment of allergic rhinitis.
4.Patients currently receiving systemic treatments such as corticosteroids or immunotherapy, or undergoing treatment for allergic rhinitis under other systems of medicine including Ayurvedic, Unani, Siddha, or other alternative therapies, and unwilling to discontinue them during the study period.
5. Patients already enrolled or registered in another clinical study during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in individual nasal symptoms and overall symptom severity using the Total Nasal Symptom Score (TNSS). |
Assessed at baseline and after 3 months of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Causal attribution between homoeopathic treatment & clinical improvement in all improved cases using the Modified Naranjo Criteria (MONARC) |
Assessed at baseline & after 3 months of intervention. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/03/2026 |
| 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="0"
Months="6"
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
|
Allergic rhinitis (AR) is a chronic IgE-mediated inflammatory condition of the nasal mucosa caused by hypersensitivity to environmental allergens such as pollen, dust mites, molds, and animal dander. It is characterized by symptoms including sneezing, nasal obstruction, rhinorrhea, and nasal itching, which can significantly impair the quality of life of affected individuals. The diagnosis is primarily based on clinical history, characteristic symptoms, and clinical examination while excluding other causes of chronic rhinitis.
Homoeopathy follows an individualized approach to treatment based on the totality of symptoms of the patient. Repertorization plays a crucial role in remedy selection, and Boenninghausen’s Characteristics and Repertory revised by C.M. Boger is one of the classical repertories used for systematic analysis of symptoms in homoeopathic practice. However, scientific evidence evaluating the effectiveness of individualized homoeopathic treatment using this repertory in allergic rhinitis remains limited.
The present study is designed as a prospective, open-label, single-arm clinical study to evaluate the effectiveness of individualized homoeopathic treatment in cases of allergic rhinitis. The study will be conducted at the OPD of the National Institute of Homoeopathy, Narela, Delhi. After explaining the details of the study in the participant’s own language, written informed consent will be obtained from all eligible participants. Detailed case taking will be carried out according to homoeopathic principles, and remedies will be selected through repertorization using Boenninghausen’s Characteristics and Repertory by C.M. Boger.
A total of 40 patients fulfilling the inclusion criteria will be enrolled through consecutive sampling and will receive individualized homoeopathic medicines based on the totality of symptoms. Each participant will be followed up periodically for a duration of three months.
The change in individual nasal symptoms and overall symptom severity will be assessed using the Total Nasal Symptom Score (TNSS) at baseline and after treatment. Reduction in the frequency of use of antihistamines during the study period will also be recorded. Any adverse drug reactions, if observed, will be documented and reported through the AYUSH Suraksha Portal as per pharmacovigilance guidelines. The causal attribution between the intervention and clinical outcome in improved cases will be assessed using the Modified Naranjo Criteria for Homeopathy (MONARCH).
The collected data will be analyzed using appropriate statistical methods to evaluate the effectiveness of individualized homoeopathic treatment in patients with allergic rhinitis. |