Treatment of renal stones with frankincense: A pilot, randomized, double?blind, placebo?controlled clinical trial to assess the safety and efficacy of a novel Boswellia sacra extract (Luban-S)

Frankincense (Luban) is a resin obtained from trees of genus Boswellia. The south of Oman hosts Boswellia sacra (BS) trees known to have many social, religious and medicinal uses. The anti-inflammatory and therapeutic potential of Luban has recently attracted the interest of the scientific community. Renal stones are common and people prefer non-surgical treatment approaches such as natural products. Recently, Al-Marhoon et al. have carried out Phase I animal study looking at the safety and efficacy of Luban and proved that it has a significant effect in the treatment and prevention of experimentally induced renal stones in rats-model. The aim of the present randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of a novel boswellic acids (Luban-S), given as the natural product in the form of capsules, for the treatment of renal stones. This is a clinical phase I and II (Safety, Efficacy) double-blind simple-randomized controlled treatment trial. In this study, 300 patients with renal stones (150 Radiopaque and 150 Radiolucent stones) will be included and divided between three treatment groups: New treatment (Luban-S), Standard treatment (Uralyt-U), and Control group (Placebo). The inclusion criteria are: adult male and female patients with renal stones 10 mm and less in size. The exclusion criteria are: patients with known existing renal pathology or comorbidities such as DM, CKD, multiple renal cysts and renal tumors. The outcome measures of the study will include: a) The primary end point: the effect of three months treatment with Luban-S on the stone size (50% reduction in stone size or complete disappearance); and b) The secondary end point: is the patients? intolerance of the treatment (toxicity) or development of some side effects. If this study proves an effect of Luban-S on renal stones it will be an outbreak in the management of renal stones using an eco-friendly extract, natural, effective and safe product.