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. 2005 Jul 20;2005(3):CD003937. doi: 10.1002/14651858.CD003937.pub2

Holodniy 1999.

Methods Multicentre, randomised, double‐blind, placebo‐controlled trial. 
 Generation of allocation sequence: table of random numbers. 
 Double blind: study personnel and subjects. 
 Withdrawal/dropouts: unclear. 
 Intention to treat analyses: unclear.
Participants Study country: USA. 
 Setting: hospital‐based inpatients. 
 51 AIDS patients with diarrhoea (26 in SP‐303 group and 25 in placebo group). 
 AIDS diagnosed by CDC criteria.
Interventions Experiment: 
 SP‐303 (herbal extract from Croton lechleri), two capsules (500 mg) oral, every 6 hours, for a total of 16 consecutive doses (32 capsules);
Control: 
 Placebo, two capsules, the same regimen as above.
41 out of 51 patients received antiretroviral therapy and 39 received at least one protease inhibitor during herbal therapy.
Outcomes Stool weight, abnormal stool frequency, stool chloride output, daily gastrointestinal index score, and adverse events.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear