NCT00822406

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

First QC Date

January 13, 2009

Last Update Submit

January 26, 2009

Conditions

Rhinitis

Keywords

allergyrhinitishomeopathydouble-blind

Outcome Measures

Primary Outcomes (1)

  • specific allergic signs and symptoms score

    6 months

Secondary Outcomes (1)

  • general allergic symptoms score

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: homeopathic medicine

2

PLACEBO COMPARATOR

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

Drug: homeopathic medicineDrug: placebo

Interventions

homeopathic medicineDRUG

individualized homeopathic medicine

12
placeboDRUG

placebo - 6 months

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate rhinitis
  • to assign written informed consent

You may not qualify if:

  • other chronic diseases
  • corticosteroid use
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20471615DERIVED

MeSH Terms

Conditions

RhinitisHypersensitivity

Interventions

Homeopathy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

July 1, 2002

Study Completion

December 1, 2006

Last Updated

January 27, 2009

Record last verified: 2009-01