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

• Sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02255136
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 73
• Patients Per Site Per Month: 1.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Rhinitis; Allergic, With Asthma	Other: Individualized homeopathic medicines; Other: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trialProspective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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 Comparator: 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	Other: Placebo; Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water; Other Names: Placebo: distilled water

Outcome Measures

Primary Outcome Measures

1. Serum Interleukin 10 and 13 level [1 year]

Secondary Outcome Measures

1. Incidence of adverse events if any [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahesh Bhattacharyya Homeopathic Medical College & Hospital	Howrah	West Bengal	India	711104

Sponsors and Collaborators

• Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Investigators

• Principal Investigator: Shubhamoy Ghosh, MD(Hom), Lecturer of the Department of Pathology & Microbiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Shubhamoy Ghosh, MD (Hom), Lecturer of the Department of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
• ClinicalTrials.gov Identifier: NCT02255136
• Other Study ID Numbers: 793/MBHMCH/CH/Adm/01/2011; CTRI/2012/02/002419
• First Posted: Oct 2, 2014
• Last Update Posted: Aug 16, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Dr. Shubhamoy Ghosh, MD (Hom), Lecturer of the Department of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital: Interleukin; Immunoglobulin; Homeopathy; Allergic Rhinitis; Asthma
• Additional relevant MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic

Study Results

No Results Posted as of Aug 16, 2018