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

Phase 3

Recruiting

• Conditions: Edema, Nephrotic syndrome, Proteinuria; C12.777.419.630.643; C12.777.934.734; C23.888.277

• Registration Number: RBR-9fjfnh
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.