Effect of Rosehip (1 gram daily for two months) on Pain Severity in Patients with Chronic Coronary Syndrome
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 consists of outpatients diagnosed with chronic coronary syndrome who have met the inclusion and exclusion criteria for the study and are using medication or placebo at home for 2 months. At the beginning and after 2 months of using medication or placebo, patients are evaluated in terms of exercise test parameters at Dr. Dastani's office and the hospital. Patients and evaluators are blinded to the type of medication and placebo group.
Participants/Inclusion and exclusion criteria
Adult patients diagnosed with chronic coronary syndrome and without organ dysfunction
Intervention groups
In the treatment group, tablets containing 500 mg of hydroalcoholic extract of the rose hip, 2 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 and nitrates. Placebo tablets will be used in the control group.
Main outcome variables
Individual information, history of previous illnesses, and medications used by the patient will be recorded at the beginning of the study. The primary measurable outcomes of the study are: total exercise time tolerance, time to onset of angina symptoms, electrocardiographic changes, double product, and Duke treadmill score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120520009801N15
Registration date:2025-06-08, 1404/03/18
Registration timing:prospective
Last update:2025-06-08, 1404/03/18
Update count:0
Registration date
2025-06-08, 1404/03/18
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Consuming Tablets Containing Rosehip Fruit Alcoholic Extract on Pain Severity in Patients with Chronic Coronary Syndrome
Public title
Effect of rosehip on chronic coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Chronic Stable Angina Based on Clinical and Laboratory Parameters
Obtaining Informed Consent from the Patient or Patient's Companion
Absence of contraindications for exercise testing
Exclusion criteria:
Conditions that may compromise the electrocardiogram (ECG) or exercise test interpretation
Congestive heart failure functional class III or IV
History of acute coronary syndrome
Any method of coronary revascularization within two months of enrollment
Pregnancy or breastfeeding
Renal insufficiency (GFR < 60 ml/min)
Liver failure (child pugh score B or C)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
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, 12 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
2025-04-26, 1404/02/06
Ethics committee reference number
IR.MUMS.REC.1404.040
Health conditions studied
1
Description of health condition studied
chronic coronary syndrome
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Total duration of exercise test capacity
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
2
Description
Time to onset of angina
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
3
Description
Electrocardiographic changes
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
4
Description
Double product
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
5
Description
Duke score
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
Secondary outcomes
1
Description
Blood pressure
Timepoint
At baseline and two months after intervention
Method of measurement
Manometer
2
Description
Heart rate
Timepoint
At baseline and two months after intervention
Method of measurement
Exercise test system
3
Description
Lipid profile
Timepoint
At baseline and two months after intervention
Method of measurement
Blood test
4
Description
Complete blood count(CBC)
Timepoint
At baseline and two months after intervention
Method of measurement
Blood test
5
Description
Fasting blood sugar
Timepoint
At baseline and two months after intervention
Method of measurement
Blood test
6
Description
Liver function test
Timepoint
At baseline and two months after intervention
Method of measurement
Blood test
7
Description
Kidney function profile
Timepoint
At baseline and two months after intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: tablets containing 500 mg of hydroalcoholic extract of rose hip prepared in the pharmacognosy and pharmaceutical laboratory of Mashhad Faculty of Pharmacy, 2 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, 2 tablets daily oral for 2 months
Category
Treatment - Drugs
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
Fax
Email
b.ghaem@mums.ac.ir
2
Recruitment center
Name of recruitment center
Dr. Mustafa Dasanti's office
Full name of responsible person
Mostafa Dastani
Street address
kafaee street
City
Mashhad
Province
Razavi Khorasan
Postal code
36025070
Phone
+98 51 3848 1096
Email
dastanim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
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
tafaghodiM@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
9177948954
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
9177948954
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
9177948954
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
The use of data is unimpeded by mentioning the source.
From where data/document is obtainable
Dr. AmirHoushang Mohamadpour Mail: mohamadpoorah@mums.ac.ir Phone: 09153162909
What processes are involved for a request to access data/document