Allegra 1981.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: table of random numbers Exclusions post randomisation: none Losses to follow‐up: none |
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Participants | Country: Italy Setting: hospital Number: 80 patients Age: not stated Gender: not stated Inclusion criteria: patients with postphlebitic syndrome, oedema of the lower limb, phlebolymphoedema, constitutional venous stasis, varices Exclusion criteria: not stated |
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Interventions | Treatment: 2 × 10 mg Centella tablets 3 × per day Control: placebo Duration: 30 days Follow‐up: 30 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) | Low risk | Quote: "The assignment of patients to one of two treatments, labelled as A or B, was made randomly using a special randomization list" Comment: a randomisation list is generally accepted as a fair method of ensuring a random sequence |
Allocation concealment (selection bias) | Unclear risk | Comment: no information given about methods used for allocation concealment |
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: no exclusions post randomisation and no losses to follow‐up |
Selective reporting | Unclear risk | Comment: the number of participants in both groups was described. However, a table with important characteristics was lacking; this could lower the generalisability. Adverse events, tolerability and signs of intolerance were presented |
Other bias | Low risk | Comment: none detected |