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Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Primary Purpose

Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
homeopathic medicine
placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis focused on measuring allergy, rhinitis, homeopathy, double-blind

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate rhinitis
  • to assign written informed consent

Exclusion Criteria:

  • other chronic diseases
  • corticosteroid use
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)

    This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.

    Outcomes

    Primary Outcome Measures

    specific allergic signs and symptoms score

    Secondary Outcome Measures

    general allergic symptoms score

    Full Information

    First Posted
    January 13, 2009
    Last Updated
    January 26, 2009
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00822406
    Brief Title
    Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
    Official Title
    Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis
    Keywords
    allergy, rhinitis, homeopathy, double-blind

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
    Intervention Type
    Drug
    Intervention Name(s)
    homeopathic medicine
    Intervention Description
    individualized homeopathic medicine
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo - 6 months
    Primary Outcome Measure Information:
    Title
    specific allergic signs and symptoms score
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    general allergic symptoms score
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: moderate rhinitis to assign written informed consent Exclusion Criteria: other chronic diseases corticosteroid use pregnancy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20471615
    Citation
    Teixeira MZ, Guedes CH, Barreto PV, Martins MA. The placebo effect and homeopathy. Homeopathy. 2010 Apr;99(2):119-29. doi: 10.1016/j.homp.2010.02.001.
    Results Reference
    derived

    Learn more about this trial

    Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

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