Pointel 1986.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 4 (4%) |
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Participants | Country: France Setting: hospital Number: 94 patients Age: mean 49 ± 12 years Gender: 8 M:86 F Inclusion criteria: CVI Exclusion criteria: severe varicose veins requiring an elastic strip, postphlebitic patients, those with unilateral venous insufficiency, those treated with a venoactive drug before the start of the study |
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Interventions | Treatment: Centella asiatica (TECA) 120 mg: two 30 mg capsules twice a day vs Centella asiatica (TECA) 60 mg: one 30 mg capsule twice a day Control: placebo Duration: 56 days Follow‐up: 56 days |
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Outcomes | Primary
Secondary
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The study conducted in four hospitals according to a controlled, randomized, double‐blind (double dummy) study performed on three parallel groups for eight weeks" Comment: no method of randomisation described |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods of allocation concealment described |
Blinding (patients) | Unclear risk | Comment: no information given about methods used for blinding |
Blinding (study researchers) | Unclear risk | Comment: no information given about methods used for blinding |
Blinding (outcome assessment) | Unclear risk | Comment: no information given about methods used for blinding |
Incomplete outcome data | Low risk | Comment: number of participants in each group described, along with inclusion and exclusion criteria and important characteristics for participants. In addition, study author reported the number of adverse events that occurred, the number of participants who withdrew prematurely and reasons for dropping out |
Selective reporting | Low risk | Comment: no protocol identified, and no differences between outcomes reported in the methods section and those reported in the results section |
Other bias | Low risk | Comment: none detected |