Protocol summary

Summary
The overall objective of this by double-blinded randomized study is to investigate the effect of aerobic exercises and herbal crataegus on cardiovascular risk factors among stable angina patients. The statistical sample of this study is almost 80 people of 45 to 65 year-old patients who referred to Imam Ali sub-specialty polyclinic, shahrekord, Iran. These people are randomly allocated in groups for 3 way method. The way in which stable angina patients presented is as follows the three experimental groups: (1) with crataegus herbal consumption, (2) aerobic exercise and placebo consumption (3) crataegus herbal consumption and aerobic exercise and one control group. In this study, patients who had been undergone coronary angiography testing. They are approved, but there was no significant stenosis. In addition, patients with heart failure treated with digoxin, anticoagulant, anti-arrhythmic drugs and cisapride are excluded. The probable beneficial effect of these drugs combined with physical activity is the method, which can be considered to be special. Because the number of studies concerning the effectiveness of physical activity and herbs, is growing around the world in a way that perhaps we can take advantage of these two factors as a new strategy in the prevention and treatment of complications associated with anti-inflammatory medication and supplements. Because of, the importance of this issue and achieving effective results, the researcher was to investigate the effect of aerobic training and herbal remedies (crataegus) on processes and factors affecting atherosclerosis and cardiovascular risk factors.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021812521N1
Registration date: 2013-04-21, 1392/02/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Alireza Nematollahi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 4912
Email address
nematollahi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-08-05, 1392/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Crataegus herbal consumption or aerobic excercise on risk factors of cardiovascular diseases in patients with stable angina pectoris
Public title
Effects of cratagus herbal consumption and erobic exercise in patients with stable angina pectoris
Purpose
Prevention
Inclusion/Exclusion criteria
In this study, petients who had been undergone coronary angiography testing . They are approved, but there was no significant stenosis. In addition, patients with heart failure treated with digoxin, anticoagulant , anti-arrhythmic drugs and cisapride are excluded.
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Aerobic exercise combind with herbal medicine as a new strutegy

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shahrekord university of Medical sciences
Street address
Ayatollah Kashani Blvd
City
shahrekord
Postal code
8815713471
Approval date
2012-10-22, 1391/08/01
Ethics committee reference number
91-8-23

Health conditions studied

1

Description of health condition studied
Patients with stable angina pectoris
ICD-10 code
I20.9
ICD-10 code description
Angina pectoris, unspecified

Primary outcomes

1

Description
CRP
Timepoint
Before The intervention, and three months after intervention
Method of measurement
Mg per deciliter

2

Description
IL-6
Timepoint
Before The intervention, and three months after intervention
Method of measurement
Mg per deciliter

Secondary outcomes

1

Description
Resting heart rate
Timepoint
Before interfered
Method of measurement
bpm

2

Description
Heart rate reserve
Timepoint
Before interfered
Method of measurement
bpm

3

Description
Maximum heart rate
Timepoint
Before interfered
Method of measurement
bpm

Intervention groups

1

Description
Crataegus herbal, 240 mg pill, two times a day for three months.
Category
Treatment - Drugs

2

Description
Aerobic exercise, 15 to 20 minutes, two times a day for three months.
Category
Rehabilitation

3

Description
Placebo, 240 Mg pill, two times a day with aerobic exercise, 15 to 20 minutes, two times a day for three months.
Category
Placebo

4

Description
Control group with no intervention for three months.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Imam Ali sub-specialty polyclinic
Full name of responsible person
Heidari Mojtaba
Street address
Shariati Blvd
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord Imam Ali sub-specialty polyclinic
Full name of responsible person
Dr. Mobasheri Mahmoud
Street address
Ayatollah Kashani Blvd
City
Shahrekord
Grant name
1238-90-01-91
Grant code / Reference number
969
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord Imam Ali sub-specialty polyclinic
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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Rafieian Mahmoud
Position
Head of Medicinal Plants Research
Other areas of specialty/work
Street address
Third floor, Centre for Medicinal Plants Research, Faculty of Medicine, Rahmatieh
City
Shahrekord
Postal code
8813833435
Phone
+98 213813346692
Fax
+98 213813334911
Email
rafieian@skums.ac.ir
Web page address
medplit.kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad university, Khorasgan, Isfahan
Full name of responsible person
Jalaly leila
Position
Graduate Student in exercise physiology
Other areas of specialty/work
Street address
University Blvd, Arghavanieh, East J street, Isfahan
City
Isfahan
Postal code
81595158
Phone
+98 213115354001
Fax
+98 213115354060
Email
Leila_jalaly@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
shahrekord University
Full name of responsible person
Dr. Faramarzi Mohamed
Position
Associate professor
Other areas of specialty/work
Street address
Department of physical Education, Facultu of Engineering, Saman Road 2 miles
City
Shahrekord
Postal code
8818634141
Phone
+98 213814420361
Fax
+98 213814420361
Email
md.faramarzi@gmail.com
Web page address
www.sku.ac.ir

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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