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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-04-30

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

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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.

Conditions

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Rhinitis; Allergic, With Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Individualized homeopathic medicines

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

Group Type EXPERIMENTAL

Individualized homeopathic medicines

Intervention Type OTHER

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

Intervention placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Individualized homeopathic medicines

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Placebo: distilled water

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No