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Curcuma longa (Tumeric) as an auxiliary treatment for Idiopathic Childhood Nephrotic Syndrome

Curcuma longa as adjuvant in the treatment of Idiopathic Childhood Nephrotic Syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9fjfnh
Enrollment
Unknown
Registered
2018-01-02
Start date
2017-07-01
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

Edema, Nephrotic syndrome, Proteinuria

Interventions

Patients will be allocated randomly: 1) Control Group: receive placebo, and 2) Experimental Group: which receives extract of Curcuma longa in addition to conventional treatment. The standard treatment
Drug
E02.190.755

Sponsors

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Collaborator

Eligibility

Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: The study will include all patients older than one year; who have the diagnosis of idiopathic childhood nephrotic syndrome; who are followed up at the Childhood Nephrology Clinic of the Clinics Hospital of Ribeirão Preto of the University of São Paulo, (i.e. ANEI); and whose parents or legal guardians authorize participation through signature of informed consent.

Exclusion criteria

Exclusion criteria: Will not be included in the project those patients younger than one year; those with nephritic syndrome characteristics; with another etiology for the nephrotic syndrome, as secondary causes (e.g. IgA nephropathy, membranoproliferative glomerulonephritis, systemic lupus erythematosus and secondary to Infectious diseases); or whose parents or legal guardians disagree with their participation in the research.

Design outcomes

Primary

MeasureTime frame
It is expected a change in the classification of the behavior of the Idiopathic Childhood Nephrotic Syndrome, in a period of 1 year, with quarterly evaluations, through comparisons between the placebo and treatment groups, made by Fisher's exact test, Student's t-test or Mann's-Whitney U test, from the observation of a response with an magnitude effect of 0.50.

Secondary

MeasureTime frame
Decreased number of relapses during and after corticosteroid withdrawal, during the 1-year period, observed in the quarterly evaluations.;Faster resolution of proteinuria in the induction phase of daily cortiscoteroid remission (Phase 1) during the 1-year period, observed in the quarterly evaluations.

Countries

Brazil

Contacts

Public ContactFábio;Ivan Carmona;Machado

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo;Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

carmona@usp.br;ivancmachado@gmail.com55(16)3602-1000;55(16)98250-5052

Outcome results

None listed

Source: REBEC (via WHO ICTRP)