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. |
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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 |