Protocol summary

Summary
Stable angina pectoris patients are a high number of referrals to cardiology clinics. In patients with coronary artery involvement less than 50 percent in whom invasive treatments are not indicated, medical treatment plays an important role in the symptom management and their quality of life. In case of resistance to medication, complementary medicine like acupuncture may help. 40 patients with stable angina and normal coronary angiography who are resistant to medical treatment, will be interred the study and randomized to experimental and control groups. The routine medical treatment will be prescribed for patients of both groups and the experimental group will receive acupuncture treatment for 4 weeks. All patients will be followed up till week 8.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512037265N2
Registration date: 2015-12-08, 1394/09/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-08, 1394/09/17
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Mashhad University Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of acupuncture on refractory chest pain of the patients with patent coronary angiogram
Public title
Studying the effect of acupuncture on refractory chest pain of the patients with patent coronary angiogram
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with typical angina pectoris with coronary artery involvement less than 50 percent. 2- Being an appropriate candidate for medical treatment. 3- Being resistant to maximal dosage of medical treatment. Exclusion criteria: 1- Being a candidate for revascularisation 2- Left ventricular systolic function less than 30 percent 3- ِDetection of acute coronary syndrome in each study stage
Age
From 5 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics committee of Mashhad University of Medical Sciences
Street address
MUMS' central office, Daneshgah street
City
Mashhad
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
900578

Health conditions studied

1

Description of health condition studied
Angina pectoris
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
number of chest pain episodes per week
Timepoint
0, end of week 4, end of week 8
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Medical treatment & acupuncture
Category
Treatment - Other

2

Description
Control: Medical treatment only
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Hoda Azizi
Street address
Center for Acupuncture and massage, Imam Reza Hospital
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
MUMS' Central office, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and Complementary Medicine, School of Traditional and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hoda Azizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
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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