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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  
Status 
Not Applicable 
 
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.

 
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