| CTRI Number |
CTRI/2025/11/096811 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Verification of Homoeopathic medicines for the treatment of Allergic Rhinitis. |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic medicines in Persistent and Perennial Allergic Rhinitis: Double Blind, Randomized, Placebo-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 Reshma Chandrabhanji Hiwrale |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic medical College and hospital, Gomtinagar lucknow |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic medical College and hospital Gomtinagar lucknow .
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9473854481 |
| Fax |
|
| Email |
rhreshma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Vijay kumar Pushkar |
| Designation |
Principal |
| Affiliation |
State National Homoeopathic medical College and hospital Gomtinagar lucknow |
| Address |
State National Homoeopathic medical College and hospital Gomtinagar lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9415466529 |
| Fax |
|
| Email |
vijay04pushkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Om Prakash Singh |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic medical College and hospital Gomtinagar lucknow |
| Address |
Department of Organon of Medicine, State National Homoeopathic medical College and hospital Gomtinagar lucknow.
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7839318990 |
| Fax |
|
| Email |
dr.opsingh10@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital gomtinagar Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Reshma Chandrabhanji Hiwrale |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic medical College and hospital Gomtinagar lucknow. 226010 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Om Prakash Singh |
State National Homoeopathic medical College and hospital Gomtinagar lucknow |
| Dr Tulika |
State National Homoeopathic medical College and hospital Gomtinagar lucknow |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reshma Chandrabhanji Hiwrale |
State National Homoeopathic Medical College and Hospital |
OPD 7 , State National Homoeopathic Medical College and Hospital Gomtinagar Lucknow Lucknow UTTAR PRADESH |
9473854481
rhreshma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee State National Homoeopathic medical College and hospital |
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 |
Individualized Homoeopathic Medicine |
Experimental arm will receive individualized homoeopathic medicine after detailed case taking and repertorization. Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consists of 4-5 globules of cane sugar moistened with single medicine (preserved in 90% ethanol) to be taken orally on clean tongue. Dosage and repetition will depending on individual requirement of cases. |
| Comparator Agent |
Placebo |
Comparator arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo will consists of 4-5 globules of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue, dosage and repetition depending on individual requirement of cases. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases suffering from Allergic Rhinitis persistent and perennial variety and of moderate intensity for more than 1 year.
2. Atopic: reactive to inhaled allergens
3. Literate patients: can read hindi or/and english
4. Providing written informed consent to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1.Nasal abnormalities causing obstruction, e.g. nasal polyp and deviated nasal septum.
2.Allergen avoidance in the past 6 weeks.
3.Away from usual environment for more than 1 week during the trial.
4.Respiratory infections.
5.Patients at risk of developing bronchial asthma.
6.Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
7.Patients who are too sick for consultation.
8.Unwilling to take part and not giving consent to join the study.
9.Unable to read the patient information sheet.
10.Pregnant, puerperal women, and lactating mothers.
11.Substance abuse and/or dependence.
12.Self-reported immunocompromised state.
13.Use of oral or parenteral steroids in the past 6 months.
14.Conventional desensitization in the past 6 months.
15.Previous homeopathic immunotherapy for perennial allergic rhinitis.
16.Undergoing homeopathic treatment for any chronic disease within the last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of individualized homoeopathic medicine in comparison with placebo in treatment of persistent and perennial allergic rhinitis. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to detect the group differences in RQLQ and VAS measures of nasal, non-nasal and and global severity and QOL over 3 months.
2. To shortlist the most frequently indicated homoeopathic medicines in the treatment of allergic rhinitis. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
15/11/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study titled “Efficacy of Individualized Homoeopathic Medicines in Persistent and Perennial Allergic Rhinitis” is a double-blind, randomized, placebo-controlled clinical trial conducted at NHMC, Lucknow. It aims to evaluate the effectiveness of individualized homoeopathic medicines compared to placebo in improving symptoms and quality of life among patients with persistent and perennial allergic rhinitis. A total of 140 participants, aged between 18 and 65 years, were enrolled according to specific inclusion and exclusion criteria and randomly assigned to two parallel groups — experimental (individualized homoeopathic medicines in centesimal potencies) and control (indistinguishable placebo) groups.
Randomization was carried out using a computer-generated random number chart, ensuring equal allocation and minimizing selection bias. Both the participants and investigators were blinded to the treatment assignment to maintain the integrity of the trial. Participants were followed for three months, during which both subjective and objective outcomes were recorded and were regularly followed up to monitor symptom changes and treatment responses. The primary outcome was assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), while secondary outcomes included Visual Analogue Scale (VAS) scores for nasal and non-nasal symptoms, along with overall quality-of-life assessment. Ethical approval, informed consent, and prospective trial registration were obtained. The study design ensures methodological rigor and aims to determine whether individualized homoeopathic treatment offers a statistically significant advantage over placebo in managing allergic rhinitis. |