The effect of tablets containing the alcoholic extract of rose hip (one gram daily for two months) on echocardiography parameters of patients with slow coronary artery flow
Design
Double-blinded randomized controlled clinical trial with parallel groups, phase 3 on 30 patients. For randomization, the permutation block method was used using the www.randomization.com website.
Settings and conduct
The study group is outpatients diagnosed with slow coronary artery flow who have completed the inclusion and exclusion criteria of the study and use the drug or placebo for 2 months at home. At the beginning and after 2 months of taking drug or placebo, patients are evaluated in terms of echocardiography parameters in the hospital. Patients and evaluators are blinded to the type of drug and placebo group.
Participants/Inclusion and exclusion criteria
Patients diagnosed with slow flow of coronary arteries but without aneurysms in coronary arteries and without organ dysfunction
Intervention groups
In the treatment group, tablets containing 250 mg of hydroalcoholic extract of the rose hip, 4 times a day for 2 months will be added to the standard treatment regimen of slow coronary artery flow including ACEIS / ARBS, beta-blockers, aspirin and atorvastatin. Placebo tablets will be used in the control group.
The effect of rose hip alcoholic extract on transthoracic Doppler echocardiography parameters in patients with coronary slow flow
Public title
Effect of rose hip on coronary slow flow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of slow flow review based on angiography results
CTFC (corrected TIMI frame count) > 27
Obtaining the consent of the patient or the patient's companion
Exclusion criteria:
Aneurysm in the coronary arteries
Patients with hyperhomocysteinemia
Patients with myocarditis
Patients with pericarditis
Patients with cardiomyopathy
The presence of ectasia in epicardial coronary vessels
Not having a suitable view for electrocardiography
Pregnancy or lactation
Kidney or liver failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate a random allocation sequence with a guarantee of equal allocation of individuals to the two groups is a permutation block created using the website www.randomization.com. With the explanation that each block has 4 members and the shape of the blocks is as follows:
[AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB]
Code A belongs to the intervention group and code B belongs to the control group. Therefore, 18 quadruple blocks were randomly generated by the site and patients were assigned to two study groups based on the sequence obtained from the above blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocation concealment method is using opaque sealed envelopes with random sequences obtained from the random allocation step. The codes are given to the researcher present in the hospital. This researcher is fully aware of the type of codes. Medications are also given to him on the basis of the number (A or B) and he is fully aware of which drug or placebo. At the end of study, the evaluator (physician) who does not know which drug the patient has received and is aware only of the assigned code, performs the relevant evaluations and after registration, the results are given to the person who performs data analysis.
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 Sciences
Street address
Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.MUMS.REC.1401.125
Health conditions studied
1
Description of health condition studied
Coronary artery slow flow syndrome
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris
Primary outcomes
1
Description
PDV (peak diastolic velocity)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
2
Description
MDV (mean diastolic velocity)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
3
Description
PDP (peak diastolic pressure)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
4
Description
MDP (mean diastolic pressure)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
5
Description
Dvti(diastolic time velocity)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
6
Description
Dint (diastolic flow interval)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
7
Description
VTI (time velocity integral)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
8
Description
LVEF (left ventricular ejection fraction)
Timepoint
at baseline and two months after intervention
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Adverse reactions of rose hip tablet
Timepoint
Two months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: tablets containing 250 mg of hydroalcoholic extract of rose hip prepared in the pharmacognosy and pharmaceutical laboratory of Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets prepared in the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy, 4 tablets daily oral for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mostafa Dastani
Street address
Ahmedabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Vice Chancellor for Research and Technology, third floor of Ghoreshi building, next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@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
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
6519472972
Phone
+98 51 1882 3255
Email
mohamadpoorah@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Mention the source
From where data/document is obtainable
Amir Hoshang Mohammadpour Phone number: 0098 9153162909
Email: MohamadpoorAH@mums.ac.ir
What processes are involved for a request to access data/document