Protocol summary

Summary
Several clinical trials and case series have provided evidence, supporting the use of CoQ10 in the prevention and treatment of various disorders related to oxidative stress. It has been shown that CoQ10’s antioxidant properties and central role in mitochondrial oxidative phosphorylation make it useful as adjunct therapy for cardiovascular diseases such as CHF, hypertension, stable angina, drug-induced cardiotoxicity, and ventricular arrhythmia, and non-cardiac conditions including cancer, periodontal disease, compromised immune systems, COPD, and muscular dystrophy. Therefore, we are advocating its use as a supplement In a prospective randomized double-blind sequential sampling. All patients with community acquired pneumonia(CAP) accidentally referring to two groups. In group A addition to the usual treatment of CAP (based on the infectious diseases society of America guideline), will receive Co- enzyme Q-10 200 mg daily for 14 days, and in Group B, in addition to the usual treatment (based on the infectious diseases society of America guideline), will receive a placebo. As well as the two groups will be matched (GROUP MATCHING) and information of patients in the two groups include demographic data and changes to the clinical symptoms and laboratory (including CBC, ESR, CRP qualiitative, ABG) at the beginning of the third , seventh and fourteen day of therapy will check with the use of a questionnaire, and finally data were analyzed by SpSS using Chi square and Fisher exact test and student test and odds ratio will be doing and the P-value less than 0.05 To be considered significant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305159855N3
Registration date: 2013-06-02, 1392/03/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Aiasghar Farazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 6526
Email address
dr.farazi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2013-11-15, 1392/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Co- enzyme Q-10(Ubiquinone) in geriatrics community-acquired pneumonia
Public title
Efficacy of Co- enzyme Q-10 in pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : age≥65; Community acquired pneumonia patients exclusin criteria : the age of less than 65 years ; hemodynamic instability ; chronic liver failure; chronic heart failure; chronic renal failure ; Co- enzyme Q-10 consumption during 1 month before arrival to study; history of allergic reactions; receiving the drugs or compounds with antioxidant effect such as vitamin C; vitamin E or vitamin A; HIV patients
Age
From 65 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Arak University of Medical Sciences
Street address
Sardasht, Arak University of Medical Sciences,Arak
City
Arak
Postal code
Approval date
2012-12-06, 1391/09/16
Ethics committee reference number
91-137-8

Health conditions studied

1

Description of health condition studied
community acqured pnemonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae

2

Description of health condition studied
community acqured pnemonia
ICD-10 code
J14
ICD-10 code description
Pneumonia due to Haemophilus influenzae

3

Description of health condition studied
community acqured pnemonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified

Primary outcomes

1

Description
Clinical Signs and Symptoms(Temprature,Respiratory rate,Pulse rate,Blood pressure,Dyspnea,Sputum production,Crackle and rale)
Timepoint
0,3,7,14
Method of measurement
Physical examination based on quastionair

Secondary outcomes

1

Description
Decrease of leukocyte count
Timepoint
0,3,7,14
Method of measurement
Complet blood count

2

Description
Decrease of CRP and ESR
Timepoint
0,3,7,14
Method of measurement
Check of ESR and CRP

3

Description
Blood O2 Saturation
Timepoint
0,3,7,14
Method of measurement
Check of blood O2

Intervention groups

1

Description
Iintervention group :Standard traetment of pneumonia (Ceftriaxon + Azithromycin ) + Coenzyme Q 100mg BID for 14 days
Category
Treatment - Drugs

2

Description
Control group : Standard treatment of pneumonia(ceftriaxon + Azythromycin)+ placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital of Arak
Full name of responsible person
Aliasghar Farazi
Street address
Department of infectious diseases, valiasr hospital,Arak,Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saeed Changizi Ashtyani
Street address
Management of Research services,Sardasht, Arak University of Medical
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ghazaleh Akbarifard
Position
Secretary of research Council
Other areas of specialty/work
Street address
Sardasht,Arak,Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
gakbarifard@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of infectious diseases , Vali asr hospital,Arak
City
Arak
Postal code
Phone
+98 86 1223 6588
Fax
Email
farazialiasghar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
farazialiasghar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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