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IRCT20191216045758N1 IRCT 2020-10-21 Mashhad University of Medical Sciences Evaluation of the Effect of the Drug "Mumiaee" on the Union Period of Distal Radius Fractures Evaluation of the Effect of the Drug "Mumiaee" on the Union Period of Distal Radius Fractures: A Randomized Clinical Trial 2020-10-05 anticipated 44 Complete https://irct.ir/trial/50448 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2-3 Condition 1: Distal Right Radius Fracture. Condition 2: Distal Left Radius Fracture. Intervention 1: Intervention group: consists of 22 patients who will receive 4 capsules of Mumiaee (Shilajit) containing 250 mg of the substance (a total of 1000 mg per day) every 6 hours, daily for 1 month. This medicine is produced in Pharmacological Herbs Research Institute of Mashhad University of Medical Sciences. Mumiaee (Shilajit) has been commonly used in tradition medicine over the years. This substance consists of Amino Acids, Albominoids, Fatty Resinoic Acids, Benzoic Acid, Hippuric Acid. The most important substance in this medicine is Fulvic Acid which has anti-inflammatory and anti-oxidant effects. Mumiaee also contains mineral such as Copper, Magnesium, Calcium, Manganese, Nickel, Iron, Zinc, Lithium and Molybdenum. Intervention 2: Control group: consists of 22 Patients who will recieve 4 placebo capsules, containing 100 mg of Avisel Powder, every 6 hours daily for 1 month. Avisel Powder consists of Microcrystalline Cellulose. Yes - There is a plan to make this available What will be shared: All data potentially can be shared after anonymization of the participants. When: Data access allowed 6 months after publication of the research To whom: Researchers working in academic and scientific institutes Conditions: With the permission of the author, there is no problem with using the documentation. Where to obtain: Kimia Emami Email: kimia.emami.96@gmail.com Dr. Ali Moradi (MD, PhD) Email: almor0012@gmail.com How to obtain: The document can be sent in less than one month via email. Comments:
public Ali Moradi
Orthopedic Surgery Department, Emam Reza Hospital, Emam Reza Square, Ebne Sina Street.
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3854 3031 moradial@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Moradi
Orthopedic Surgery Department, Emam Reza Hospital, Emam Reza Square, Ebne Sina Street.
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3854 3031 moradial@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Closed Fractures Fernandez Fractures type 1-3 that are fixed by PCP or External Fixators. Lack of Rheumatoid Disease, Diabetes and Immune Deficiency in the past medical history of the participants. 18 years 80 years Both Pathological Fractures Underlying Bones Diseases such as Osteopetrosis Unexpected Special Medical Conditions S52.501A S52.502A Unspecified fracture of the lower end of right radius, initial encounter for closed fracture Unspecified fracture of the lower end of left radius, initial encounter for closed fracture Treatment - Other Treatment - Other Intervention group: consists of 22 patients who will receive 4 capsules of Mumiaee (Shilajit) containing 250 mg of the substance (a total of 1000 mg per day) every 6 hours, daily for 1 month. This medicine is produced in Pharmacological Herbs Research Institute of Mashhad University of Medical Sciences. Mumiaee (Shilajit) has been commonly used in tradition medicine over the years. This substance consists of Amino Acids, Albominoids, Fatty Resinoic Acids, Benzoic Acid, Hippuric Acid. The most important substance in this medicine is Fulvic Acid which has anti-inflammatory and anti-oxidant effects. Mumiaee also contains mineral such as Copper, Magnesium, Calcium, Manganese, Nickel, Iron, Zinc, Lithium and Molybdenum. Control group: consists of 22 Patients who will recieve 4 placebo capsules, containing 100 mg of Avisel Powder, every 6 hours daily for 1 month. Avisel Powder consists of Microcrystalline Cellulose. Union Period of Distal Radius Fracture. Timepoint: At the beginning of the study and on the weeks 2, 4, 6, 8, 10, 12. Method of measurement: Wrist X-Ray. Wrist Range of Motion. Timepoint: On the weeks: 2, 4, 6, 8, 10 and 12. Method of measurement: By using Goniometer. Wrist Pain and Disability in Activities of Daily Living. Timepoint: After the initial treatment and the start of Mumiaee (Shilajit) consumption on the weeks 6 and 12. Method of measurement: By using Patient-Rated Wrist Evaluation questionnaire. Physical Function of Upper Limb. Timepoint: At the start of Mumiaee (Shilajit) consumption on the weeks 6 and 12. Method of measurement: By using Quick Disabilities of Arm, Shoulder and Hand questionnaire. Patient's Wrist Pain. Timepoint: At the start of Mumiaee (Shilajit) consumption on the weeks 6 and 12. Method of measurement: By Visual Analog Scale Pain questionnaire. Hand Grip Strength. Timepoint: After the initial treatment and the start of Mumiaee (Shilajit) consumption on the weeks 6 and 12. Method of measurement: By Orthopedic Equipment Dynamometer. Mashhad University of Medical Sciences Approved 2020-08-11 Ethics Committee of Mashhad University of Medical Sciences Medicine Faculty, Ferdowsi University of Mashhad, Azadi Square. Mashhad Razavi Khorasan Iran (Islamic Republic of)