Efficacy of Momiai in Tibia Fracture Repair: A Randomized Double-Blinded Placebo-Controlled Clinical Trial.

ABSTRACT

Objectives: Momiai ( shilajit, mummy, mumie, or mineral pitch) has been used traditionally in different medical systems for the treatment of a variety of ailments since hundreds of years ago. It is a natural substance found in different rocky parts of the world, formed by plants, mineral, and animal remains gradually. There is also worthwhile evidence supporting its oral use for bone repair in Persian medicine. The aim of this study was to evaluate the efficacy and safety of momiai in tibia fracture healing. Design: This study is a randomized double-blinded controlled trial. Settings/Location Three different hospitals in Tehran, Iran. Subjects: Patients with age range of 18-60 years admitted due to new tibia fracture were enrolled after meeting the inclusion criteria. Interventions: The patients were divided into two groups randomly and received two 500 mg capsules of momiai or placebo for 28 days. Outcome measures: The process of bone healing was assessed by frequent X-ray radiographies and adverse effects were recorded. Results: Totally, 160 patients participated in the study either in two equal intervention or placebo groups. There was no significant difference between groups in terms of demographic and descriptive data. At the end of the study, the mean time of tibial bone union was 129 days in the experimental group, while it was 153 days in the placebo group (p < 0.049). There was no significant difference in the reported adverse effects between the two groups (p = 0.839). Conclusions: The current study showed that oral consumption of momiai after tibial shaft fracture surgery could be a promising option to reduce the healing time.