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Completed

NCT Number: NCT02255136

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

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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Key information

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahesh Bhattacharyya Homeopathic Medical College & Hospital

Howrah, West Bengal, 711104, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized homeopathic medicines

Other

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

Placebo

Other

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

Other names: Placebo: distilled water

Primary outcomes

  1. Serum Interleukin 10 and 13 level

    Time frame: 1 year

Secondary outcomes

  1. Incidence of adverse events if any

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Other Gov

Registry information

Official study 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

Acronym: SBRCTHILARBA

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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