Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00822406
First received: January 13, 2009
Last updated: January 26, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Rhinitis
Drug: homeopathic medicine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • specific allergic signs and symptoms score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • general allergic symptoms score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: July 2002
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: 1
This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)
Drug: homeopathic medicine
individualized homeopathic medicine
Placebo Comparator: 2
This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
Drug: homeopathic medicine
individualized homeopathic medicine
Drug: placebo
placebo - 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate rhinitis
  • to assign written informed consent

Exclusion Criteria:

  • other chronic diseases
  • corticosteroid use
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcus Zulian Teixeira, Hospital das Clínicas da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00822406     History of Changes
Other Study ID Numbers: marcus@homeozulian.med.br
Study First Received: January 13, 2009
Last Updated: January 26, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
allergy
rhinitis
homeopathy
double-blind

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014