RhinitisPhase 4NCT00822406
Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
A Phase 4 study testing homeopathic medicine in people with Rhinitis, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- homeopathic medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate rhinitis
- to assign written informed consent
Who cannot join
- other chronic diseases
- corticosteroid use
- pregnancy
About this study
Official title: Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
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
- Being tested
- homeopathic medicine, placebo
- Keywords
- allergy, rhinitis, homeopathy, double-blind
- Medical subject headings
- Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homeopathic medicineDrug
individualized homeopathic medicine
placeboDrug
placebo - 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase) Receives: 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. Receives: Drug: homeopathic medicine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific allergic signs and symptoms score
Measured: 6 months
Secondary outcomes (1)
general allergic symptoms score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJul 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822406
- Sponsor's protocol ID
- marcus@homeozulian.med.br
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20471615
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00822406
- Acronym / sponsor ID
- marcus@homeozulian.med.br
- Conditions
- Rhinitis
- Keywords
- allergy, rhinitis, homeopathy, double-blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: homeopathic medicineThis arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase) |
| 2 | Placebo comparator | Drug: homeopathic medicine, Drug: placeboThis arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate rhinitis
- to assign written informed consent
Key exclusion criteria (3 listed)
- other chronic diseases
- corticosteroid use
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| homeopathic medicineindividualized homeopathic medicine | Drug | 1, 2 |
| placeboplacebo - 6 months | Drug | 2 |
Primary outcome
specific allergic signs and symptoms score
Time frame: 6 months
1 secondary outcome
general allergic symptoms score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
- Derived from this study: PubMed 20471615Teixeira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing homeopathic medicine in people with Rhinitis, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specific allergic signs and symptoms score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2009.