Protocol summary

Study aim
Determining and comparing the effect of oral coenzyme Q-10 consumption on the results of treatment of adult distal radius fractures
Design
Double-blind clinical trial study
Settings and conduct
Single blind clinical trial study will be performed on patients referred to Imam Khomeini Hospital in the age range of 18 to 40 years old. Gender opinion should be equal in both groups. In the intervention group, patients will receive 100 mg of Q-10 daily for 8 weeks, and in the control group, patients will not receive Q-10. This group will receive a placebo. Then, in the postoperative visits in weeks 4 and 8, the radiographic findings of the fusion will be examined. The DASH questionnaire will be used to evaluate the patient's function, the VAS score will be used to evaluate the pain, and the dynamometer will be used to evaluate the grip strength of the hand. And the data will be recorded. Performance is expressed and calculated based on the DASH questionnaire and this questionnaire consists of 30 questions, each of which receives between one point and five points based on the severity of the disorder, and the total score will be calculated and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Distal radius fracture with metaphysical instability according to AO criteria group C1, C2, A3 and A2 or an intra-articular fracture line and displacement in an adult who has been treated by skin pinning. Exclusion criteria: Patients with displaced intra-articular fractures requiring open surgery. People with underlying disease or taking drugs that interfere with bone metabolism
Intervention groups
Intervention group of patients 100 mg Q-10 daily for 8 weeks. Control group: placebo.
Main outcome variables
Union speed; grip strength; function; pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211228053554N1
Registration date: 2022-03-22, 1401/01/02
Registration timing: prospective

Last update: 2022-03-22, 1401/01/02
Update count: 0
Registration date
2022-03-22, 1401/01/02
Registrant information
Name
siyamak kazemisofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 9538
Email address
kazemisofi.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral Co enzyme Q10 effect on the outcomes in adults patients with Distal Radius fracture
Public title
Assessment of oral Co enzyme Q10 effect on the outcomes in adults patients with Distal Radius fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (age 18 to 40 years old) with distal radius fracture
Exclusion criteria:
Patients with intra-articular fractures who require open surgery
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly divided into two groups of treatment (100 mg Q-10 daily for 8 weeks) and control (placebo of neutral drug) with random allocation software (Random Allocation software).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be performed by double-blind method (patients and physicians' treatment team). After a distal radius fracture with metaphysical instability according to the AO criteria of groups C1, C2, A3, and A2, or an intra-articular fracture line and displacement in an adult who has been treated by skin pinning by a specialist Orthopedics It was found that participants will be referred to a secretary to receive medication or placebo and will deliver them (medication or placebo) in two groups of patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.UMSU.REC.1400.19

Health conditions studied

1

Description of health condition studied
Adult distal radius fractures
ICD-10 code
S52.50
ICD-10 code description
Adult distal radius fractures

Primary outcomes

1

Description
Duration of the distal radius fracture union
Timepoint
Before prescribing supplements and in weeks 4 and 8
Method of measurement
Radiography

2

Description
Hand grip strength
Timepoint
Before prescribing supplements and in weeks 4 and 8
Method of measurement
Dynamometer

3

Description
Intensity of pain
Timepoint
Before prescribing supplements and in weeks 4 and 8
Method of measurement
VAS pain score

4

Description
Patient performance
Timepoint
Before prescribing supplements and in weeks 4 and 8
Method of measurement
DASH performance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, patients will receive 100 mg of Q-10 daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: patients receiving(placebo of neutral drug)for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini University Hospital
Full name of responsible person
Dr. Siamak Kazemi Sufi
Street address
Imam Khomeini University Hospital- Ershad Ave.- Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 912 014 9654
Fax
+98 44 3345 7277
Email
Kazemisofi.s@umsu.ac.ir
Web page address
http://imam.umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 912 014 9654
Fax
+98 44 3223 4897
Email
Saber@Umsu.ac.ir
Web page address
http://Imam.Umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Siamak Kazemi Sufi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini University Hospital- Ershad Ave.- Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
Kazemisofi.s@umsu.ac.ir
Web page address
http://imam.umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Siamak Kazemi Sufi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini University Hospital- Ershad Ave.- Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
Kazemisofi.s@umsu.ac.ir
Web page address
http://imam.umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Siamak Kazemi Sufi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini University Hospital- Ershad Ave.- Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
Kazemisofi.s@umsu.ac.ir
Web page address
http://imam.umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...