This is an interventional study that evaluates the effect of oral Arabic Gum compared with placebo on the union fractures of the distal radius bone. The focus group includes adults with age 20-60 consciously selected and randomly divided into intervention and control groups.
Besides conventional orthopedic treatment (replacement and fixation by plaster) for each patient, the supplement and placebo will be prescribed at the 8th day after the fracture for a duration of 21 days. The intervention group will take Arabic Gum powder and the control group will take dried bread powder as placebo.
Radiologic Union Score System (callus formation and disappearance of fracture line) will be evaluated in both intervention and control groups in the third, fourth and sixth weeks after the fracture by two orthopedic specialists. Simple plain and lateral wrist x ray roentgenography are the choice Radio-graphic tests. Clinical criteria for healing based on Numeric Rating Scale System (hyperalgesia and active and passive wrist movement quality) will be evaluated at the sixth week (at the time of opening of plaster).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040327196N1
Registration date:2017-07-12, 1396/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Farshad Amini Behbahani
Name of organization / entity
School of Traditional Medicine, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5569 3098
Email address
aminibehbehani.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Vice chancellor for research, Iran University of Medical Sciences
2- Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences
Expected recruitment start date
2017-06-09, 1396/03/19
Expected recruitment end date
2018-06-09, 1397/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Acacia Arabica as an adjuant therapy with placebo in healing of the distal radius bone fracture
Public title
The effect of Arabic gum on radius fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Distal radius bone fractures with displacement (type A of AO Classification)
Exclusion criteria: partial or complete intra-articular fractures. (Type B and C category AO); multi-piece fractures (Type C classification AO); fractures with internal or external fixation management criteria; Bilateral fractures or presence of fractures in the other bones (except distal radius and ulnar); initiation of treatment 24 hours or more after the fracture; association of vascular or nervous complications; Multiple Trauma; open fracture; History of previous fracture in the same position; fracture with dislocation of the wrist bones; pathological fractures; Chronic diseases such as diabetes, cancer, auto immune diseases, inflammatory kidney diseases, coronary heart diseases or advanced pulmonary diseases; decreased consciousness; pregnancy or lactation; alcohol addiction; tobacco or drug addiction; allergies to herbal medicines.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
IR.IUMS.REC.1394.8911558006
Health conditions studied
1
Description of health condition studied
Distal fracture of radius bone
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Callus formation and disappearance of fracture line
Timepoint
Week 3 and 4 and 6
Method of measurement
radiography
Secondary outcomes
1
Description
Pain assessment at the touch position and active/passive movement of fractured wrist
Timepoint
At the end of the sixth week after the opening of plaster
Method of measurement
Numeric Rating 11-point scale
Intervention groups
1
Description
Intervention group: replacement + plaster + follow-up radiographies and visits by Orthopedist + 500 mg Arabic Gum capsule twice daily (at the morning and evening) for 21 days duration.
Category
Treatment - Drugs
2
Description
Control group: replacement + plaster + follow-up radiographies and visits by Orthopedist + 500 mg dried bread powder capsule twice daily (at the morning and evening) for 21 days duration.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dr Moayeri Hospital
Full name of responsible person
Masood Hatami
Street address
Shahid Dr Moayeri Hospital, in front of Parliament, Mojahedin e Islam street, Shohada Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
,Iran University of Medical Sciences ,Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences
Full name of responsible person
Fataneh Hashem Dabaghian
Street address
No. 9, Pirnia alley, Lalezar Now Ave., Jomhouri Eslami St., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine, School of Iranian Traditional Medicine, I
Full name of responsible person
Masood Hatami
Position
PhD candidate of traditional medicine MD
Other areas of specialty/work
Street address
Shohada sq. Mjahedine Islam st. in front of Parliament- shahid moayyeri hospital
City
Tehran
Postal code
Phone
+98 217753110
Fax
Email
Dr_mh48@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine, School of Iranian Traditional Medicine, I
Full name of responsible person
Farshad Amini Behbahani
Position
Traditional Medicine MD-PhD/ Head of of Traditional Medicine Department
Other areas of specialty/work
Street address
No 62, Behasht st, Hafez St.
City
Tehran
Postal code
Phone
+98 21 5558 0388
Fax
Email
aminibehbehani.f@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine, School of Iranian Traditional Medicine, I
Full name of responsible person
Farshad Amini Behbahani
Position
Head of Traditional Medicine Department/ Traditional Medicine MD-PhD
Other areas of specialty/work
Street address
no.62, Behesht street, Hafez street, Tehran
City
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Fax
Email
aminibehbehani.f@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)