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

August 15, 2018 updated by: Dr. Shubhamoy Ghosh, MD (Hom), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Howrah, West Bengal, India, 711104
        • Mahesh Bhattacharyya Homeopathic Medical College & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serum Interleukin 10 and 13 level
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events if any
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shubhamoy Ghosh, MD(Hom), Lecturer of the Department of Pathology & Microbiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 793/MBHMCH/CH/Adm/01/2011
  • CTRI/2012/02/002419 (Registry Identifier: Clinical Trial Registry - India)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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