]>
IRCT2013052013389N1 IRCT 2014-01-19 Vice chancellor for research, Shahid Beheshti University of Medical Sciences The effect of oral mummy drug on bone fracture Comparing effect of oral Mummy drug (Mountain Sweat) with placebo in healing time of tibia bone shaft fracture in adult men 2014-02-22 anticipated 60 Complete https://irct.ir/trial/13247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Drug and placebo will be prepared in the same form of capsule and packaging. Then they will be coded by a third person. After matching intervention and control groups with respect to the type of fracture, they will take drug and placebo randomly. Consequently the patients and researcher are not notified of the group assigned until the end of the study. 2 Tibia bone shaft fracture. Intervention 1: Administration of oral mummy drug, daily total of four capsules, for 4 weeks, each capsule contains 250 mg of oral mummy drug. It should be taken with water one hour before or three hours after meals. Intervention 2: Administration of Golha wheat flour (0000) in form of edible capsules similar to the packaging of oral mummy drug, a total of four capsules daily for 4 weeks.
public Sayed Mohammad Hassan Sadeghi
No. 8, Shams Alley, Vali Asr St.
Tehran Iran (Islamic Republic of) +98 21 8877 3521 Dr.smhs@yahoo.com School of Traditional Medicine, Shahid Beheshti University of Medical Sciences scientific Sayed Mohammad Hassan Sadeghi
No. 8, Shams Alley, opposite, Vali Asr St.
Tehran Iran (Islamic Republic of) +98 21 8877 3521 Dr.smhs@yahoo.com School of Traditional Medicine, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. The male gender 2. Fracture of tibia bone shaft 3. Initiation of intervention in less than 10 days from the time of fracture 4. Age between 18 and 50 5. Completing the consent form Exclusion criteria: 1. Orthopedic complication that prevents the continuation of the research process (in consultation with orthopedic surgeon and researcher) 2. The unpredictable complications leading to intolerance of medication or placebo such as idiosyncratic complications (in consultation with orthopedic surgeon and researcher) 3. Taking medications that affecting the bone repair 4. Surgery again 5. Pathological fracture 6. Underlying disease affecting the recovery process of fractures of the bone (immunodeficiency, tumor, osteoporosis, liver or renal failure) 7. Addiction 8. Severe infection of the bone or tissue around the location of the fracture or damage of the artery (according to the criteria of the Gustillo-Anderson 3C or 3B) 18 years 50 years Male S82.2 Fracture of shaft of tibia Treatment - Drugs Placebo Administration of oral mummy drug, daily total of four capsules, for 4 weeks, each capsule contains 250 mg of oral mummy drug. It should be taken with water one hour before or three hours after meals. Administration of Golha wheat flour (0000) in form of edible capsules similar to the packaging of oral mummy drug, a total of four capsules daily for 4 weeks Union time of tibia bone shaft fracture. Timepoint: Two, four, six, eight, ten and twelve weeks after the start of the intervention. Method of measurement: Swiss-ray digital radiology device. Side effects. Timepoint: Two, four, six, eight, ten and twelve weeks after the start of the intervention. Method of measurement: Questionnaire. Vice chancellor for research, Shahid Beheshti University of Medical Sciences Approved 2013-09-14 Ethics committee of Shahid Beheshti University of Medical Science Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway Tehran Iran (Islamic Republic of)