7.4 PHASE III CLINICAL TRIAL OF Blumea Balsamifera, L (SAMBONG) TABLET IN THE TREATMENT OF URINARY TRACT STONES: A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.

7.4.1 Abstract

Sambong (Blumea balsamifera, L) tablets as Anti-Urolithiasis

The general objective of the clinical trial was to compare the efficacy and safety of sambong and placebo tablets, given at 40 mg/kg BW in three divided doses daily among 22-60 year old patients with urinary tract stones (> 5 mm at its greatest axial diameter) documented in excretory urograms. Forty subjects were screened and 19 qualified with 13 subjects completing the study, with 6 dropouts. There were 13 males and 6 females; ratio of 2.1:1. Majority of the patients were between 31 and 50 years of age. Duration of illness ranged from within 30 days of enrollment into the study (N=9), 2 within several months and in 3 patients, several years duration. The chief complaints were moderate to severe pain and signs/ symptoms referable to urinary disturbance. The most commonly used drugs were antimicrobials, analgesics or anticolic agents. Excretory urogram demonstrated solitary stone in ten patients while the rest had multiple stones. There were eleven subjects in the sambong group who completed the study and two in the placebo group. All the dropouts were in the placebo group.

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