A Study on the Effect of Q10 Coenzyme viaTissue Doppler Method in Improving Cardiac Function in Patients with Early Duchenne Cardiomyopathy Aged 6-10 Years
Purpose of the Study: The effectiveness of Q10 Coenzyme via Tissue Doppler method in improving cardiac function in patients with early Duchenne Cardiomyopathy aged 6-10 years.
Inclusion criteria: The patients with Duchenne muscular dystrophy aged between 6 -10 years; parental consent to enter the study; without cardiac disease in the intervention group; without structural cardiac disease in the control group; untreated with herbal, vitamin and enzyme medications.
Exclusion criteria: The patients without Duchenne muscular dystrophy; Patients age less than 6 years or above 10 years; parental lack of consent for entering the study; Patients with cardiac disease in the intervention group; Patients with structural cardiac disease in the control group; inappropriate echocardiography; Patients treated with of herbal s, vitamin and enzyme medications.
Study population: Children 6-12 years old suffering Duchenne cardiomyopathy will refer to neurology clinic of Children's Medical Center.
Sample size: Twenty four people; including 12 patients in the control group and 12 in the intervention group.
Intervention: The effect of Q10 Coanzyme on improving cardiac function; cardiac marker tests, 3 and 6 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070223018N1
Registration date:2015-08-11, 1394/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-11, 1394/05/20
Registrant information
Name
Forod Salehi Abarghoei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 893 6844
Email address
farhanghih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Education at Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
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
A Study on the Effect of Q10 Coenzyme viaTissue Doppler Method in Improving Cardiac Function in Patients with Early Duchenne Cardiomyopathy Aged 6-10 Years
Public title
Effect of Q10 Coenzyme in Improving Cardiac Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with Duchenne muscular dystrophy aged between 6 -10 years; parental consent to enter the study; without cardiac disease in the intervention group; without structural cardiac disease in the control group; untreated with herbal, vitamin and enzyme medications.
Exclusion criteria: The patients without Duchenne muscular dystrophy; Patients age less than 6 years or above 10 years; parental lack of consent for entering the study; Patients with cardiac disease in the intervention group; Patients with structural cardiac disease in the control group; inappropriate echocardiography; Patients treated with of herbal s, vitamin and enzyme medications.
Age
From 6 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research and Education at Tehran University of Medical Sciences
Street address
Central Department of the University, on the corner of Ghods street, Keshavarz boulvard
City
Tehran
Postal code
Approval date
2012-10-03, 1391/07/12
Ethics committee reference number
1512/130د/91
Health conditions studied
1
Description of health condition studied
Duchenne Moscular Dystrophy
ICD-10 code
G71.0
ICD-10 code description
Muscular dystrophy
Primary outcomes
1
Description
Left ventricular filling index
Timepoint
3 and 6 months after using the medication
Method of measurement
Tissue doppler
Secondary outcomes
1
Description
E Declaretion
Timepoint
3 and 6 months after using the medication
Method of measurement
Eco
Intervention groups
1
Description
Control group: A group of patients being treated with oral placebo on a daily basis for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group: A group of patients being treated with oral Q10 Coanzyme (dose: 3 mg) on a daily basis for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Children's Medical Center
Full name of responsible person
Hossain Jabbari
Street address
Digestive Diseases Research Institute ﴾DDRI, ﴿ Tehran University of Medical Sciences ﴾TUMS, ﴿Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Education at Tehran University of Medical Sciences
Full name of responsible person
Gholam Reza Hassan Pour
Street address
Amir Abad, Keshavarz boulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Education at Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zenanloo
Position
Professor of Cardiologist
Other areas of specialty/work
Street address
Amir Abad, Keshavarz boulvard
City
Tehran
Postal code
Phone
+98 21 8898 9664
Fax
Email
zenanloo@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Forod Salehi Abarghoee
Position
Cardiologist
Other areas of specialty/work
Street address
Amir Abad, Keshavarz boulvard
City
Tehran
Postal code
Phone
+98 21 8898 9664
Fax
Email
hamidsalehi500@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Forod Salehi Abarghoee
Position
Other areas of specialty/work
Street address
Amir Abad, Keshavarz boulvard
City
Tehran
Postal code
Phone
+98 21 8898 9664
Fax
Email
hamidsalehi500@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)