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

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Rhinitis; Allergic, With Asthma

Interventions

Individualized homeopathic medicinesOTHER

5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year

PlaceboOTHER

Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mahesh Bhattacharyya Homeopathic Medical College & Hospital

Howrah, West Bengal, India

Outcomes

Primary Outcomes

Serum Interleukin 10 and 13 level

Time frame: 1 year

Secondary Outcomes

Incidence of adverse events if any

Time frame: 1 year

Data from ClinicalTrials.gov

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