A- Study population: Patients with tibia bone shaft fracture who admit to the Akhtar Hospital. Study objectives: To assess the effect of oral mummy drug (Mountain Sweat) on union time of tibia bone shaft fracture in adult patients admitting to Akhtar Hospital in 2014. Study Design: Randomized, double-blind, placebo-controlled, single-center, phase II clinical trial. Main inclusion criteria: 1. The male gender 2. Fracture of tibia bone shaft 3. Less than 10 days from the time of fracture to initiation of intervention 4. Age between 18 and 50 Main exclusion criteria: 1. Orthopedic complication that prevents the continuation of the research process (in consultation with orthopedic surgeon and researcher) 2. Taking medications that affecting the bone repair 3. Surgery again 4. Pathological fracture 5. Underlying disease affecting the recovery process of fractures of the bone (immunodeficiency, tumor, osteoporosis, liver or renal failure) 6. Addiction
B- The study intervention or interventions: Administration of oral mummy drug (1 gram per day) or placebo (Wheat flour) to patients in capsule form
C- Intervention duration: 28 days
D- The primary outcome or outcomes studied: Acceleration of the fracture union
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052013389N1
Registration date:2014-01-19, 1392/10/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-19, 1392/10/29
Registrant information
Name
Sayed Mohammad Hassan Sadeghi
Name of organization / entity
School of Traditional Medicine, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3522
Email address
smhsadeghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Government sources
Expected recruitment start date
2014-02-22, 1392/12/03
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of oral Mummy drug (Mountain Sweat) with placebo in healing time of tibia bone shaft fracture in adult men
Public title
The effect of oral mummy drug on bone fracture
Purpose
Treatment
Inclusion/Exclusion criteria
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)
Age
From 18 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2013-09-14, 1392/06/23
Ethics committee reference number
400/4014
Health conditions studied
1
Description of health condition studied
Tibia bone shaft fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Side effects
Timepoint
Two, four, six, eight, ten and twelve weeks after the start of the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Sayed Mohammad Hassan Sadeghi, Ph.D. student of Traditional Medicine