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. 2012 Apr 18;2012(4):CD003964. doi: 10.1002/14651858.CD003964.pub3
Methods
  • Study design: parallel RCT

  • Losses to follow‐up/withdrawals: None

Participants
  • Setting: inpatients recruited from paediatric department of general hospital

  • Country: China

  • Ethnicity: Chinese

  • Inclusion criteria: primary nephrotic syndrome diagnosed on "the National Diagnostic Criteria for Nephrotic Syndrome in Children", including simple nephrotic syndrome and nephritis nephrotic syndrome

  • Course of disease: 1 day to 26 months

  • Number: 92 children

  • Age (range): 2.0 to 13.7 years

  • Gender (M/F): 57/35


Exclusion criteria: NS
Interventions Treatment group
  • Huangqi (astragalus) granules (oral)

    • Dose: 7.5 g bid (< 3 years);10 g bid (3 to 6 years); 15 g bid (> 6 years)

    • Duration: 3 months

  • Baseline treatment including standard steroid protocol for nephrotic children


Control group
  • Baseline treatment including standard steroid protocol for nephrotic children


Duration of follow‐up: 8 months
Outcomes
  • Nosocomial infection

    • Diagnostic criteria: NS

  • Adverse events

Notes
  • Spectrum of nosocomial infection in order of incidence: respiratory infection, UTI, gastrointestinal infection, skin infection.

  • Spectrum of microorganisms: NS

  • Source of funding: NS

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk The patients with nephrotic syndrome were allocated to the treatment and control groups according to the order of admission.
Allocation concealment (selection bias) Unclear risk The study did not provide the information on allocation concealment.
Blinding (performance bias and detection bias) All outcomes Unclear risk The study did not provide the information on blinding.
Incomplete outcome data (attrition bias) All outcomes Low risk There were no missing data in this study.
Selective reporting (reporting bias) Unclear risk There was insufficient information to make judgement.
Other bias Unclear risk There was insufficient information to make judgement.