Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

NCT ID: NCT00822406

Last Updated: 2009-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-12-31

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.

Conditions

Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

homeopathic medicine

Intervention Type: DRUG

individualized homeopathic medicine

2

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

Group Type: PLACEBO_COMPARATOR

homeopathic medicine

Intervention Type: DRUG

individualized homeopathic medicine

placebo

Intervention Type: DRUG

placebo - 6 months

Interventions

homeopathic medicine

individualized homeopathic medicine

Intervention Type: DRUG

placebo

placebo - 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• moderate rhinitis
• to assign written informed consent

Exclusion Criteria

• other chronic diseases
• corticosteroid use
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Hospital das Clínicas da Universidade de São Paulo

References

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.

Reference Type: DERIVED

PMID: 20471615 (View on PubMed)

Other Identifiers

marcus@homeozulian.med.br

Identifier Type: -

Identifier Source: org_study_id