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

Primary Purpose

Rhinitis; Allergic, With Asthma

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Individualized homeopathic medicines
Placebo
Sponsored by
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis; Allergic, With Asthma focused on measuring Interleukin, Immunoglobulin, Homeopathy, Allergic Rhinitis, Asthma

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mahesh Bhattacharyya Homeopathic Medical College & Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Individualized homeopathic medicines

Intervention placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Serum Interleukin 10 and 13 level

Secondary Outcome Measures

Incidence of adverse events if any

Full Information

First Posted
February 15, 2012
Last Updated
August 15, 2018
Sponsor
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02255136
Brief Title
Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis; Allergic, With Asthma
Keywords
Interleukin, Immunoglobulin, Homeopathy, Allergic Rhinitis, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized homeopathic medicines
Arm Type
Experimental
Arm 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
Arm Title
Intervention placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Individualized homeopathic medicines
Intervention Description
5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo: distilled water
Intervention Description
Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water
Primary Outcome Measure Information:
Title
Serum Interleukin 10 and 13 level
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of adverse events if any
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shubhamoy Ghosh, MD(Hom)
Organizational Affiliation
Lecturer of the Department of Pathology & Microbiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahesh Bhattacharyya Homeopathic Medical College & Hospital
City
Howrah
State/Province
West Bengal
ZIP/Postal Code
711104
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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