Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Phase 4

Completed

• Conditions: Rhinitis
• Interventions: Drug: homeopathic medicine; Drug: placebo

• Registration Number: NCT00822406
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study Completion: 2006-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• moderate rhinitis
• to assign written informed consent

Exclusion Criteria

• other chronic diseases
• corticosteroid use
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	homeopathic medicine	This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)
2	homeopathic medicine	This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
2	placebo	This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.

Primary Outcome Measures

Name	Time	Method
specific allergic signs and symptoms score	6 months

Secondary Outcome Measures

Name	Time	Method
general allergic symptoms score	6 months