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

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Status: Completed

Conditions: Rhinitis; Allergic, With Asthma

Treatments: Other: Placebo; Other: Individualized homeopathic medicines

Study type: Interventional

Funder types: Other

Identifiers

NCT02255136

CTRI/2012/02/002419 (Registry Identifier)

793/MBHMCH/CH/Adm/01/2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 5 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Individualized homeopathic medicines

Experimental group

Description:

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

Treatment:

Other: Individualized homeopathic medicines

Intervention placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo