The efficacy of Padma 28, a herbal preparation, in the treatment of intermittent claudication: A controlled double-blind pilot study with objective assessment of chronic occlusive arterial disease patients

Padma 28, a complex herbal formula, has been used successfully in clinical trials to improve pain-free walking distance in patients with intermittent claudication. Using objective, non-invasive techniques of vascular testing, a randomised, 6 month double-blind pilot study assessed the efficacy, safety and tolerance of Padma 28 in patients with peripheral arterial occlusive disease (PAOD), compared to controls. Padma 28 patients displayed a significant mean improvement of 12% in exercise-induced drop of ankle pressure and 0.8 min in pressure recovery time compared to pre-treatment values. An improvement in pressure drops by more than 15%, compared to a deterioration or no change, occurred in 48% of Padma 28 patients compared to 22% of controls. Calculation of the 'ischaemic window', a quantitative expression of post-exercise hyperaemia, showed a significant reduction of 54% following treatment with Padma 28 compared to 18.8% in controls. Self-assessment by patients revealed that perceived improvement in pain-free walking ability in the Padma 28 group correlated significantly with improvement in exercise-induced drop of ankle pressure. Padma 28 was well tolerated, with minimal unwanted side effects and associated with a significant improvement in patient well-being compared to controls. The pilot study demonstrates that following the stress of exercise, changes in ankle systolic pressure and its recovery time are positively affected by Padma 28. While the precise mode of action requires clarification, results suggest that Padma 28 may be an effective treatment for intermittent claudication.