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Homeopathy in the discontinuation of inhaled corticosteroid during the treatment of teenagers with perennial asthma

Individualized homeopathic medicines vs. placebo for clinical control of perennial asthma in teenagers during the reduction of inhalatory beclometasone: exploratory, randomized, double-blind, controled trial - SIBILIBUS study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-6xts8z
Enrollment
Unknown
Registered
2017-05-06
Start date
2012-08-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial asthma

Interventions

Open label phase: inhaled beclomethasone (250 mcg two times a day) and fenoterol (0,25 mg/3 Kg - for wheezing episodes), and a indivualized homeopathic medicine for each patient. Once good asthma con
250 mcg - every other day (weeks 5-8)
discontinuation, if possible (weeks 9-12). At the beginning of the step-down phase, patients will be randomly assigned to continue the individualized homeopathic medicine or to indistinguishable place
Drug

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Ambulatório da Criança da Rede Pública de Saúde - Guarulhos/SP
Collaborator

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: Subjects with diagnosis of perennial asthma; using inhalatory beclometasone; presenting dyspnea; and or tightness in the chest; and or cough; and or effort dyspnea; and or other atopic diseases, such as rhinitis, conjunctivitis, dermatitis.

Exclusion criteria

Exclusion criteria: Severe perennial asthma presenting exacerbations requiring hospital admission or systemic medication

Design outcomes

Primary

MeasureTime frame
Primary outcome is the number of days of good clinical control during the reduction of inhaled corticotherapy. Expected outcome is a significantly greater mean in the group randomized to continue with Homeopathy group, as compared to placebo.

Secondary

MeasureTime frame
Number (mean) of days of bronchodilator (B2-agonists) use; moderate exacerbations (defined as use of an emergency room not resulting in hospital admission); patients excluded due to asthma exacerbation indicating poor clinical control; adverse events. Expected outcome are significantly lower means in the group randomized to continue with Homeopathy group, as compared to placebo.

Countries

Brazil

Contacts

Public ContactUbiratan Adler

Unidade de Saúde Escola da Universidade Federal de São Carlos

ubiadler@outlook.com+55 (16) 3351 8340

Outcome results

None listed

Source: REBEC (via WHO ICTRP)