The aim of this study was to evaluate the effect of Gaznab herbal product on lowering blood pressure in patients with grade 1 hypertension (systole 159-140 and diastole 99-90 mm Hg).
Design
This study is a randomized clinical trial, including intervention and control groups with parallel, three-way blind groups. Patients are randomly divided into intervention and control groups using www.sealedenvelop.com. The method of hiding the allocation is by the method of closed envelope, opaque and sealed. The sample size is 18 people in each group.
Settings and conduct
The project site is the heart clinics of Imam Reza Hospital in Mashhad. Patients randomly receive 8 weeks of Gaznab syrup or placebo syrup. In this study, three blind patients and outcome evaluators and data analyzers were assigned Unaware of groups. The 36-item Quality of Life Questionnaire and the DASS21 Stress, Anxiety and Depression Inventory are completed at the beginning and end of the study for patients.
Participants/Inclusion and exclusion criteria
Men and women aged 30-65 years
Hypertension grade1 with pressure equal to or greater than 140.90 mmHg to 159.99 mmHg
BMI greater than or equal to 27
Major conditions of non-inclusion:
presence of blood pressure greater than or equal to 180/110 mm Hg
History of hypo or hyperthyroidism
Warfarin consumption
Pregnancy or lactation
The presence of any medical or surgical disorder that could interfere with the study
Intervention groups
The intervention group was given 10 ml of herbal syrup twice a day and continued with the previous drugs, and the control group was given 10 ml of placebo syrup twice a day with the continuation of the previous drugs for 8 weeks.
Main outcome variables
Change in blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051660N1
Registration date:2021-07-15, 1400/04/24
Registration timing:prospective
Last update:2021-07-15, 1400/04/24
Update count:0
Registration date
2021-07-15, 1400/04/24
Registrant information
Name
batool jalalkamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5008
Email address
jalalkb1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-17, 1400/04/26
Expected recruitment end date
2022-07-17, 1401/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding Gaznab herbal product to standard treatment in patients with primary hypertension compared to placebo
Public title
Evaluation of the effect of Gaznab herbal product on the control of primary hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 30-65 years
Hypertension grade1 with pressure equal to or greater than 140.90 mmHg to 159.99 mmHg
Are treated with a blood pressure medication (one to three drugs based on the protocol).
BMI greater than or equal to 27
At least one month has passed since starting the medication
The person should not be at high risk (diabetes mellitus and end organ damage , etc.)
Exclusion criteria:
History of hypo or hyperthyroidism
Types of cardiac dysrhythmias (such as second and third degree block)
Allergy to medicinal plants
History of potassium greater than 5.1 or less than 3.5 m Eq / L at the first visit
Warfarin consumption
Pregnancy or lactation
History of hypermenorrhea in females
Presence of blood pressure greater than or equal to 180/110 mm Hg
The presence of any medical or surgical disorder that could interfere with the study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into control and intervention groups using random blocking method by www.sealedenvelop.com. How to hide the allocation with the envelope method is sealed opaque and sealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients are unaware that they are assigned to the control or intervention group. intervention group will be given Gaznab herbal syrup and continuation of previous drugs and the control group will be given placebo syrup and continuation of previous drugs(in the same package and color). The outcome assessor as well as the data analyst are unaware of which group the patient belongs to.
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
Mashhad Univercity Of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.MUMS.REC.1400.059
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
In baseline and after 4 week and after 8 week
Method of measurement
Sphygmomanometer
2
Description
FBS, BUN, Cr, TG, Cholesterol, SGOT, SGPT, CBC
Timepoint
Beginning and end of the study (after 8 weeks)
Method of measurement
Biochemical and Hematological blood check
Secondary outcomes
1
Description
Quality of life score
Timepoint
pretest, post-test (at the end of 8 weeks)
Method of measurement
The World Health Organization Quality of Life Questionnaire
2
Description
Stress, Anxiety and Depression score
Timepoint
pretest, post-test (at the end of 8 weeks)
Method of measurement
DASS21 Questionnaire
Intervention groups
1
Description
Intervention group: Gaznab syrup containing aqueous extract of jujube with a concentration of 15% w / v and nettle with a concentration of 10% w / v 2 times a day and each time 10 cc for 8 weeks
Category
Treatment - Drugs
2
Description
Control group:Placebo syrup of the same shape and color with the same packaging and 2 times a day and each time 10 cc for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Batool Jalalkamali
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
jalalkb1@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
Mashhad University of Medical Sciences, University Street, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.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
Batool Jalalkamali
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
jalalkb1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Motavasselian
Position
Science Committee member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Complementary Medicine, East Gate of the University Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
MotavasselianM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Batool jalalkamali
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Complementary Medicine, East Gate of the University Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
Jalalkb1@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