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

Rhinitis; Allergic, With Asthma Clinical Trial

— SBRCTHILARBA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255136
• Other study ID #: 793/MBHMCH/CH/Adm/01/2011
• Secondary ID: CTRI/2012/02/002
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Rhinitis
• Rhinitis, Allergic
• Rhinitis; Allergic, With Asthma

Intervention

Other:
• Individualized homeopathic medicines
5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year
• Placebo
Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water

Locations

Country	Name	City	State
India	Mahesh Bhattacharyya Homeopathic Medical College & Hospital	Howrah	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Interleukin 10 and 13 level		1 year
Secondary	Incidence of adverse events if any		1 year