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Effect of cupping and nutritional correction on clinical signs and blood factors of male patients with persistent chronic angina resistant to treatment

Protocol summary

Study aim
Determination of the effect of cupping and nutritional reform on clinical signs and blood factors in resistant patients with persistent cardiac angina
Design
According to the definition of the patients, 4 envelopes were prepared in 4 groups, which, based on the time of referral, take one of the envelopes.
Settings and conduct
Approximately 60 patients with stable CABG (patients with standard therapies including coronary revascularisation by endoscopy and endodontic treatment), standard drugs have not responded adequately and are not well-labeled. By the cardiologist and cardiologist at Imam Reza Hospital, Mashhad, after diagnostic procedures and treatment (medicine, angioplasty and open heart surgery) if the conditions of participation in the project They should be referred to the Iranian medical assistant (collaborator) . First, the volunteers are familiar with the research process and are fully justified by the written consent of the research goal and the availability of the research, and the probable loss and profit. The volunteers are randomly assigned into 4 intervention and control groups (3 intervention groups and one control group).
Participants/Inclusion and exclusion criteria
Male Patients with stable, heart-resistant angina
Intervention groups
Patients were randomly divided into four intervention and control groups, each with 15 subjects. In all four, patients take their standard heart rate medications. In the first intervention group, for two patients , a common cupping is performed in the second intervention group, nutrition modification, in the third intervention group, general phytopathology and nutritional correction both. In the control group, patients receive only their usual treatment.
Main outcome variables
Improve patient pain Changing blood factors include: CBC. FBS, BUN, Cr, Cholesterol, HDL-C, LDL-c, Triglyceride, SGOT,SGPT

General information

Reason for update
Acronym
UAC
IRCT registration information
IRCT registration number: IRCT20171004036564N1
Registration date: 2018-04-09, 1397/01/20
Registration timing: registered_while_recruiting

Last update: 2018-04-09, 1397/01/20
Update count: 0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Mohammad Abazari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
abazarim931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cupping and nutritional correction on clinical signs and blood factors of male patients with persistent chronic angina resistant to treatment
Public title
Effect of cupping and nutrition correction on clinical signs and blood factors of men with stable angina resistant to treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. بیماران مرد 1. Patients with minimal CAD normal coronary artery had incomplete response to drug therapy. (X syndrome) 3. CAD patients who were not suitable for CABG (Coronary Artery Bypass Grafting) and PTCA (Percutaneous Transluminal Coronary Angioplasty). The slow flow syndrome or (Y syndrome) 4. Patients with Microvascular Angina (angina caused by tiny cardiac arrhythmias) 5. Patients with visible venous PTCA patients were not involved in revascularization. 6. CABG patients with visible vascular involvement were not involved in revascularization.
Exclusion criteria:
1. Arrhythmias that lead to functional dysfunction 2. Bleed talent 3. Active thrombophlebitis 4. There is evidence of aneurysm that requires surgery. 5. Patients with significant dysfunction (Severe AL-Severe AS-Severe MS) 6. Change the way the patient continues treatment 7. Anemia (HB less than 10 and HCT less than 30) 8. Very Slim and Very Obese (BMI less than 15 and more than 35)
Age
No age limit
Gender
Male
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Envelope method According to the definition of the patients, 4 envelopes were prepared in 4 groups, which, based on the time of referral, take one of the envelopes.
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
Imam Reza Hospital - Avicenna Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.MUMS.REC.1396.227

Health conditions studied

1

Description of health condition studied
Sustained cardiac angina resistant to treatment
ICD-10 code
I20.0
ICD-10 code description
Unstable angina

Primary outcomes

1

Description
Improve patient pain
Timepoint
The beginning of the study (before the intervention) and 30 days after the intervention
Method of measurement
Seattle's Angina Inventory Complex and Paraclinical Tests

2

Description
Changing blood factors
Timepoint
The beginning of the study (before the intervention) and 30 days after the intervention
Method of measurement
Paraclinical tests

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Complete Seattle's Angina Inventory and Paraclinical Tests
Category
Other

2

Description
Intervention group: Nutrition correction
Category
Lifestyle

3

Description
Intervention group: Cupping between two scissors
Category
Treatment - Surgery

4

Description
Intervention group: Correction of nutrition and cupping between two scapula (general)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Mohammad Abazari
Street address
Imam Reza Hospital, Avicenna Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Abazarim931@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 1538
Email
Vcresearch@mums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Abazari
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Imam Reza Hospital Square (Imam Reza Hospital)
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
ABAZARIM931@MUMS.AC.IR

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Ghulabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital Square (Imam Reza Hospital)
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
GhulabiA@MUMS.AC.IR

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Abazari
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Imam Reza Hospital (AS) - Mr. Ibn Sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
ABAZARIM931@MUMS.AC.IR

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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