Evaluation of the Effect of the Drug "Mumiaee" on the Union Period of Distal Radius Fractures: A Randomized Clinical Trial

Effect of the drug "Mumiaee" on the union duration of distal radius fractures.

A two armed, randomized, superiority, parallel group clinical trial; triple- blind, in phase 2 and 3 over a group of 44 patients. Randomization is done via the software: Random Allocation.

This study is conducted on patients referred to the clinic and ward of Orthopedic Surgery in Imam Reza Hospital in Mashhad. 44 patients after informed consent and recieving the primary care will be divided into 2 arms. The intervention arm will receive 4 capsules, containing the drug Mumiaee (Shilajit) and the control arm will receive 4 capsules containing the substance Avisel (Placebo) daily for 1 month. All patients will receive a follow-up every 2 weeks including: a wrist x-ray, Physical Examinations and 3 questionnaires on week 6 and 12. The participants, the researchers including: the treating physician, the data collector and the assessor of the results will be blinded.

Patients in the age group of 18 to 80 years old with externally fixed distal radius fractures will be included; Patients with pathological fractures and underlying bone diseases or past medical histories such as Diabetes, Rheumatoid Disease or immune deficiencies that may delay the union will not be included.

Intervention arm of the study will receive 4 capsules, containing the drug Mumiaee (Shilajit), as a supplement besides their primary care, daily for 1 month. The control arm will receive 4 capsules containing the substance Avisel (Placebo), besides the primary care, daily for 1 month.

Period of union; Range of motion of the wrist; Grip Strength; Wrist fucntion evaluation by PRWE questionnaire; Upper limb activity evaluation by QDASH questionnaire;, Evaluation of pain by VAS questionnaire.

The randomization method of this clinical trial is "Blocked". The type of this research is "Superiority" and is evaluated via "Parallel" method. By using Random Allocation Software, random blocks ,with variable sizes of 4 and 6, containing equal number of each group are designed. The arrangement of contents in each block ensures the equilibrium allocation of individuals in the study groups. By patients' visits, one of the blocks is randomly chosen (via shuffling) and the patients are assigned to the groups of the study based on the content order of the block. Whenever the contents of the block, based on its size, are finished, a new block will be randomly chosen to cover the other patients and this process is repeated until all the patients are assigned to groups.

In this study, the participants and the principle researcher (the treating physician), the researcher responsible for collecting the data and the assessors of the results are blinded. The final analyzers of data, the ones writing the final article and Data Safety and Monitoring Committee are not blinded. In order to blind the study, a person who is not involved in the study, will randomly open a block by each patient visit and will draw a card based on the order of content of the block and give it to the patient. These cards are coded by color into groups A and B. One of the researchers of the study who is not blinded will later give the drug or the placebo to the patients based on the codes assigned. Therefore this study is three way blinded.

All data potentially can be shared after anonymization of the participants.

Data access allowed 6 months after publication of the research

Researchers working in academic and scientific institutes

With the permission of the author, there is no problem with using the documentation.

Kimia Emami Email: kimia.emami.96@gmail.com Dr. Ali Moradi (MD, PhD) Email: almor0012@gmail.com

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