Clinical trial NCT02255136: Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis; Allergic, With Asthma
Keywords: Interleukin
Immunoglobulin
Homeopathy
Allergic Rhinitis
Asthma
Lead sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
Sponsor class: OTHER_GOV
First posted: 2014-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Interleukin 10 and 13 level
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of adverse events if any
timeFrame: 1 year
Other outcomes:
Locations:
city: Howrah
country: India
facility: Mahesh Bhattacharyya Homeopathic Medical College & Hospital
state: West Bengal
Study officials:
affiliation: Lecturer of the Department of Pathology & Microbiology
name: Shubhamoy Ghosh, MD(Hom)
role: PRINCIPAL_INVESTIGATOR
References: