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

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ClinicalTrials.gov Identifier: NCT02255136
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Shubhamoy Ghosh, MD (Hom), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, 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 : March 2012
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: Placebo: distilled water




Primary Outcome Measures :
  1. Serum Interleukin 10 and 13 level [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Incidence of adverse events if any [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255136


Locations
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India
Mahesh Bhattacharyya Homeopathic Medical College & Hospital
Howrah, West Bengal, India, 711104
Sponsors and Collaborators
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
Investigators
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Principal Investigator: Shubhamoy Ghosh, MD(Hom) Lecturer of the Department of Pathology & Microbiology
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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 ( Registry Identifier: Clinical Trial Registry - India )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. Shubhamoy Ghosh, MD (Hom), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital:
Interleukin
Immunoglobulin
Homeopathy
Allergic Rhinitis
Asthma
Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases