Protocol summary

Summary
Crataegus effects on cardiovascular determine the index coronary artery bypass surgery. The sample size in each group 12 and a total of 24 people will be, double-blind study is done. In phase two clinical trial study. During the study, patients will be recorded incidence of myocardial ischemia and any arrhythmia. In the end, patients were evaluated in terms of variables such as blood pressure, exercise tolerance test, blood levels of C-reactive protein (crataegus to assess the effects of oxidative stress) and blood Malondialdehyde level (to assess effects on inflammatory responses crataegus) is evaluated and these variables before the start of the study. At the end of the study as well as laboratory parameters such as hemoglobin, hematocrit, CBC, liver enzymes, bilirubin, cholesterol, triglycerides, erythrocyte sedimentation was measured and compared with blood levels in the first day of the study. Participants will review the conditions of entry and non-entry. Minimum age 40 and maximum age 80 years, comorbidity of chronic diseases such as kidney, liver, diabetes and COPD;In the intervention group, on the third-day surgery crataegus 30 oral drops three times a day for a month you desire and And the control group on the third day surgery to the mix 30 drops of placebo three times a day for a month daily. Use Crataegus to help improve cardiovascular patients undergoing coronary artery bypass surgery and lower blood pressure and reduce blood fat used. Laboratory parameters such as hemoglobin, thrombocytes, liver enzymes, bilirubin, cholesterol, erythrocyte remain in the normal range.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122025772N5
Registration date: 2017-02-12, 1395/11/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Crataegus on cardiovascular parameters of patients undergoing coronary artery bypass graft
Public title
Crataegus effect on patients undergoing coronary artery bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: LVEF less than 30%; The minimum age of 40 and maximum age 80 years; techniques Off-pump coronary artery bypass grafting is a method. Exclusion criteria: require any further surgery; comorbidity to valvular disease such as kidney, liver, diabetes and COPD; The risk of serious mental illness; alcohol and drug addiction; BMI> ...
Age
From 40 years old to 80 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Science
Street address
Mashhad Medical School, Mashhad University Pardis
City
Mashhad
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
IR.MUMS.REC.1393.135

Health conditions studied

1

Description of health condition studied
coronary artery bypass graft
ICD-10 code
T82
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts

Primary outcomes

1

Description
Blood pressure
Timepoint
Before intervention,One month after intervention
Method of measurement
Mm Mercury

2

Description
Left ventricular ejection fraction
Timepoint
Before intervention, one month after intervention
Method of measurement
Percent

3

Description
Exercise tolerance test
Timepoint
Before intervention, one month after intervention
Method of measurement
Minutes

4

Description
Malondialdehyde
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

5

Description
C-reactive protein
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

6

Description
Total cholestrol
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

7

Description
LDL
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

8

Description
VLDL
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

9

Description
HDL
Timepoint
Before intervention, one month after intervention
Method of measurement
Mill igrams per deciliter

10

Description
Triglyceride
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

11

Description
Fasting blood sugar
Timepoint
Before intervention,One month after intervention
Method of measurement
Milli grams per deciliter

12

Description
ALT
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

13

Description
AST
Timepoint
Before intervention, one month after intervention
Method of measurement
Per liter

14

Description
Urea
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

15

Description
Creatinine
Timepoint
Before intervention, one month after intervention
Method of measurement
Milli grams per deciliter

16

Description
Sodium
Timepoint
Before intervention, one month after intervention
Method of measurement
mEq

17

Description
Potassium
Timepoint
Before intervention,One month after intervention
Method of measurement
mEq

18

Description
Hemoglobin
Timepoint
Before intervention,One month after intervention
Method of measurement
Milli grams per deciliter

19

Description
Hematocrit
Timepoint
Before intervention,One month after intervention
Method of measurement
Percent

20

Description
White Blood cells
Timepoint
Before intervention,One month after intervention
Method of measurement
The number of micro liters

21

Description
Red Blood cells
Timepoint
Before intervention,One month after intervention
Method of measurement
The number of micro liters

22

Description
Bilirubin
Timepoint
Before intervention,One month after intervention
Method of measurement
Milligrams per deciliter

23

Description
Sedimentation Erythrocytes
Timepoint
Before intervention,One month after intervention
Method of measurement
Mili meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: on the third-day after surgery 30 drops of crataegus, three times a day for one month daily.
Category
Treatment - Drugs

2

Description
Control group: on the third day after surgery 30 drops of placebo three times a day for one month daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital Special Clinic
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Emam Reza Hospital, Emam Reza Square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice chancellor for Research of Mashhad University of Medical Science, Ghoreyshi Building, Daneshgah Avenue
City
Mashhad
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, Mashhad University of Medical Science
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
Exir Teb Zakaria company
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Teb Zakaria company
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
Exir Teb Zakaria Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
ph.D of Pharmacology/CEO
Other areas of specialty/work
Street address
No 3, Goldis 3 avenue, Ladan boulevard
City
Mashhad
Postal code
Phone
+98 51 3502 4824
Fax
Email
exirtebzakaria@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants
Full name of responsible person
Ahmad Ghorbani
Position
Assistant Professor/ Physiology Ph.D
Other areas of specialty/work
Street address
Pharmacological Research Center of Medicinal Plants, Mashhad Medical School, Mashhad University Pardis
City
Mashhad
Postal code
Phone
+98 51 3711 2717
Fax
Email
horbania@mums.ac.ir
Web page address

Person responsible for updating data

Contact

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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