Study of the Effect of Coenzyme Q10 supplementation on inflammatory markers(high-sensitivity C-reactive protein, interleukin-6, and oxidative stress and increases antioxidant enzyme activity) in patients with COPD
Determination of the effect of COQ10 supplement on CRP inflammatory markers and oxidative stress in COPD patients
Design
Clinical trial with control group, with parallel group; Double blind, randomized
Settings and conduct
Valiasr Hospital of Birjand - South Khorasan
This study is done in the valiasr hospital in Birjand, south khorasan province.
90 patients are randomly divided into 2 intervention and control groups. blood samples are taken from patients In the beginning of the study and the antioxidant serum level is measured before the treatment is started. Then the intervention is done for 6 weeks and blood samples are taken again. Antioxidant parameters will be measured by the Lab Technician.
Of the birjand university of medical science.
In this study the administrative steps are done by the lab technician and both the patients and the project executive will be uninformed of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-subject is aged 18 or older
2- subject is not taking any Nutritional or medical supplements.
3- Subject provides written informed consent.
Exclusion criteria:
1- Refusal to give informed consent
2- diagnosis of mellitus diabetes, PTE, CKD, CAD and bacterial pneumonia
3- taking any complementary medicines
4- diagnosis of COPD with current treatment of antioxidant medicine and supplements or any medicine that affects antioxidant storage and mitocondrial system
5- death of the subject during the test
Intervention groups
The intervention group consists of 45 patients with COPD recieving two 60mg CoQ10 pills.
The control group consists of 45 patients with COPD recieving two pills containing starch..
Main outcome variables
Total anti oxidant
FEV1
FEVC
DPPD
Hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N1
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Coenzyme Q10 supplementation on inflammatory markers(high-sensitivity C-reactive protein, interleukin-6, and oxidative stress and increases antioxidant enzyme activity) in patients with COPD
Public title
Study of the effect of Coq10 on patients with shortness of breath
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years of age, no nutritional and pharmaceutical supplementation, and informed consent.
Exclusion criteria:
diagnosis of mellitus diabetes, PTE, CKD, CAD and bacterial pneumonia or taking any complementary medicines.Also diagnosis of COPD with current treatment of antioxidant medicine and supplements or any medicine that affects antioxidant storage and mitocondrial system.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
Befor and after from intervention
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method of Simple random sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study
administrative of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences