Placebo-Controlled Double-Blind Study to Determine the Efficacy of the Tibetan Plant Preparation Padma 28 for Intermittent Claudication

Author(s): Wójcicki

Abstract: Objective: To determine the efficacy of the Tibetan plant preparation Padma 28 for intermittent claudication.Design: Randomized, placebo-controlled doubleblind trial of 16 weeks duration.Setting: Secondary and tertiary care in Poland.Patients: 100 patients between the age of 35 to 65 with preestablished diagnosis of intermittent claudication, a typical anamnesis, a positive physical examination, a maximum walking distance of less than 250 m and a minimum duration of the disease of 6 months were included. Exclusion criteria were peripheral arterial occlusive disease other than Fontaine II, concomitant severe diseases, or diseases affecting walking ability, or missing steady state. 93 patients (93 %) completed the study.Intervention: Two capsules twice daily of Padma 28 (380 mg) (n = 50) or placebo (n = 50) for a duration of 16 weeks.Results: Patients receiving Padma 28 exhibited on standardized ergometry an increase of the maximum walking distance from 87.5 m (CI 78.8 - 96.2) to 187.7 m (CI 167.6 - 207.8) (p < 0.001). The patients receiving placebo showed a non significant increase of 12.5 m. The increase in walking distance of the group receiving Padma 28 as compared to placebo was highly significant after 12 (p < 0.01) and 16 weeks (p < 0.001).Conclusions: Padma 28 shows clinically relevant effectiveness in peripheral arterial occlusive disease of the lower extremities, Fontaine II, with intermittent claudication.

Keyword(s): Padma 28

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