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
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring allergy, rhinitis, homeopathy, double-blind
Eligibility Criteria
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
NCT ID
NCT00822406
First Posted
January 13, 2009
Last Updated
January 26, 2009
Sponsor
University of Sao Paulo
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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