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

Not Applicable

Completed

• Conditions: Rhinitis; Allergic, With Asthma

• Registration Number: NCT02255136
• Lead Sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-02-15
• Study Start: 2012-03
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum Interleukin 10 and 13 level	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events if any	1 year

Trial Locations

Locations (1)

Mahesh Bhattacharyya Homeopathic Medical College & Hospital; 🇮🇳 Howrah, West Bengal, India