Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma

Study Overview
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Brief Summary
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The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma

Detailed Description
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A prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial is being conducted on 100 participants (subjects 50, control 50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal. This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1 year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for independent and consequent variables will be done to test for bias. Parametric or non-parametric tests will be employed as per distribution of data at the end of the trial.

Official Title
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An Evidence-based Single-blind Randomized Controlled Trial Searching for the Efficacy of Homoeopathic Medicines in Reducing Serum Levels of Cytokines (IL - 10, 13) and Immunoglobulin E in Allergic Rhinitis and/or Induced Bronchial Asthma

Conditions
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Rhinitis; Allergic, With Asthma

Intervention / Treatment
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* Other: Individualized homeopathic medicines
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 5 and 65 years Both sexes Atopic: reactive to allergens with positive skin prick test (SPT) results and/or eosinophilia More than 1 year history of allergic rhinitis and/or induced bronchial asthma Exclusion Criteria: Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc. Previous homoeopathic immunotherapy for allergic rhinitis Allergen avoidance in past 6 weeks Away from usual environment for more than 1 week during trial Severe asthma cases as detected clinically Respiratory infection Severe concomitant disease Pregnancy, breast feeding, or likelihood of pregnancy Oral or parenteral steroids and/or decongestant in past 6 months Conventional desensitization in past 3 months

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized homeopathic medicines<br>Psorinum, Tuberculinum, Medorrhinum, Calcarea carbonica, Natrum sulphuricum etc. as indicated; Rescue medicines, e.g. Aralea racemosa, Arsenicum album, Histamine hydrochloride, House dust, Ipecacuanha, Antimonium tartaricum, Grindelia robusta etc. as indicated; 5 ml dose of indicated homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; administered twice daily for 1 year | Other: Individualized homeopathic medicines<br>* 5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year<br>|
| Placebo Comparator: Intervention placebo<br>5 ml dose made up of single drop of rectified spirit in 5 ml distilled water, identical in appearance of homeopathic medicine, to be administered twice daily for 1 year | Other: Placebo<br>* Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water<br>* Other names: Placebo: distilled water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Interleukin 10 and 13 level |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events if any |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interleukin, Immunoglobulin, Homeopathy, Allergic Rhinitis, Asthma