Evaluating the effectiveness of Rosa canina L. fruit syrup on hypertension, cholesterol and anxiety In patients with hypertension A double-blind randomized clinical trial
Determining the effectiveness of Rosa syrup on hypertension, cholesterol and anxiety in patients with hypertension
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. Stratified block randomization method was used for randomization.
Settings and conduct
Men and women aged 35 to 65 who referred to Shahid Avini Health Center new cases of HTN who are eligible to enter the study will be completed anxiety questionnaire (Hamilton).To assess HDL and LDL, blood samples are taken. Since a healthy lifestyle is an important factor in controlling HTN, the LSQ for patients is full and excluded based on whether they are in the upper or lower third of the maximum score.Other are divided into two groups. One group receives the drug and the other placebo 10cc once a day, and the duration of the study is eight weeks.
Follow-ups will be every two weeks from the beginning of treatment. Blood pressure is measured twice, five minutes apart from the dominant hand. Finally blood sample is taken for re-examination and the HQ is completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Women and men in the age 35 to 65 years
2. Systolic BP greater than or equal to 130 to 159 and diastolic BP greater than or equal to 85 to 99 mm Hg
Criteria for not entering:
1- Pregnant and lactating
2- High normal pressure and grade 1 who have CVD, especially CAD or grade 4 kidney failure or diabetes that has led to organ damage, or grade 1 with chronic grade 3 kidney failure or diabetes without organ damage
3- G6PD, hemochromatosis
4- Taking drugs such as warfarin, aspirin and lithium
Intervention groups
They randomly receive one of the two treatments of Rosa syrup and placebo in the amount of 10cc once a day and the duration of the study is eight weeks.
Main outcome variables
Systolic BP
Diastolic BP
LDL and HDL levels
Anxiety severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211017052785N1
Registration date:2022-03-26, 1401/01/06
Registration timing:prospective
Last update:2022-03-26, 1401/01/06
Update count:0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Mina Maarefvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 3705
Email address
m.maarefvand@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of Rosa canina L. fruit syrup on hypertension, cholesterol and anxiety In patients with hypertension A double-blind randomized clinical trial
Public title
Evaluating the effectiveness of Rosa canina L. fruit syrup on hypertension, cholesterol and anxiety In patients with hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women in the age of 35 to 65 years with high blood pressure
Systolic blood pressure greater than or equal to 130 to 159 and diastolic blood pressure greater than or equal to 85 to 99 mm Hg
Exclusion criteria:
Pregnant and lactating women
Patients with high normal blood pressure and grade 1 who have cardiovascular disease, especially coronary artery disease or grade 4 kidney failure or diabetes that leads to organ damage or grade 1 with chronic kidney failure grade 3 or diabetes without organ damage or organ damage due to high blood pressure The above is already specified in them.
G6PD, hemochromatosis
Taking medications such as warfarin, aspirin and lithium
Age
From 35 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided into two groups by stratified block randomization, one group receives medication and the other receives placebo.Patients (after completing the lifestyle questionnaire and excluding people who receive the upper or lower third of the score) are divided into six groups based on the score of the lifestyle questionnaire, and each of them by designing 4 blocks and selecting blocks through the lottery, they receive one of two drug or placebo options, respectively, based on the block plan.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs used in the present study were prepared by the second executor, which has nothing to do with sampling and prescribing drugs. It is prepared in anonymous packs and given to the researcher. The contents of the packs remain completely confidential and will only be available to the drug manufacturer. The name of the medicine will be given to the personnel when the side effects of the medicine occur. The placebo is prepared by considering the necessary standards in color, smell, taste, shape, etc.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.ABZUMS.REC.1400.350
Health conditions studied
1
Description of health condition studied
HTN
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
First visit and then every two weeks until the eighth week
Method of measurement
Digital sphygmomanometer
2
Description
Blood HDL and LDL levels
Timepoint
Beginning and end of the trial
Method of measurement
Laboratory experiment
3
Description
Severity of anxiety
Timepoint
Beginning and end of the trial
Method of measurement
Hamilton anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To prepare Rosa syrup (according to USP 39 – NF 34, Second Supplement Commentary, June 1, 2016): 100 grams of washed Nastaran fruit soaked in 1000 cc of water, after 3 hours, boiled for 10 minutes and cooled in the laboratory. After cooling, we filter the contents of the container with a filter and concentrate the obtained product using a benmary. From 100 grams of Nastaran fruit, 8 grams of dry extract obtained from the extract obtained, 5 grams of it are brought to 100 grams using USP syrup making model with 7.66 grams of honey and 28.5 grams of water. The resulting syrup is poured into 120 cc sterile jars and sealed and sterilized by autoclave. The designed label is then installed and delivered for clinical trial. The raw materials of the medicine are prepared from reliable sources and the initial evaluation of its quality is done.
Category
Treatment - Drugs
2
Description
Control group: Placebo is prepared by considering the necessary standards in color, smell, taste, shape, etc. It will be consumed at a rate of 10cc once a day, half an hour before lunch and for a period of eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Avini Comprehensive Health Center
Full name of responsible person
Dr. Mina Maarefvand
Street address
Kianmehr, Amir Kabir Boulevard, Azadi Boulevard
City
Karaj
Province
Alborz
Postal code
2633204636
Phone
+98 26 3320 4636
Email
dr.m.maarefvand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Hatem Godini
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mina Maarefvand
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
dr.m.maarefvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mina Maarefvand
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
dr.m.maarefvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mina Maarefvad
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
dr.m.maarefvand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Part of the data, such as information about the main consequences, can be shared by inserting it in the study article.
When the data will become available and for how long
Access period starts 8 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to advance scientific goals
From where data/document is obtainable
Dr. Maarefvand
dr.m.maarefvand@gmail.com
What processes are involved for a request to access data/document
Send the request for information via the announced gmail and the party will receive a response within a maximum of two weeks.