NCT02255136

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

6.1 years

First QC Date

February 15, 2012

Last Update Submit

August 15, 2018

Conditions

Rhinitis; Allergic, With Asthma

Keywords

InterleukinImmunoglobulinHomeopathyAllergic RhinitisAsthma

Outcome Measures

Primary Outcomes (1)

  • Serum Interleukin 10 and 13 level

    1 year

Secondary Outcomes (1)

  • Incidence of adverse events if any

    1 year

Study Arms (2)

Individualized homeopathic medicines

EXPERIMENTAL

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

Intervention placebo

PLACEBO COMPARATOR

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

Interventions

Individualized homeopathic medicinesOTHER

5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year

Individualized homeopathic medicines
PlaceboOTHER

Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water

Also known as: Placebo: distilled water
Intervention placebo

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahesh Bhattacharyya Homeopathic Medical College & Hospital

Howrah, West Bengal, 711104, India

Location

MeSH Terms

Conditions

RhinitisRhinitis, AllergicAsthma

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Shubhamoy Ghosh, MD(Hom)

    Lecturer of the Department of Pathology & Microbiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of the Department of Pathology & Microbiology

Study Record Dates

First Submitted

February 15, 2012

First Posted

October 2, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

IN(1)