Protocol summary
-
Study aim
-
Determination of antihypertensive effect of antioxidant enriched extract of Ziziphus jujuba fruit in patients with primary hypertension
-
Design
-
Two arm parallel groups randomized trial with blinded postoperative care and outcome assessment
-
Settings and conduct
-
Patients with primary hypertension (hypertension and stage 1) referred to the clinic of Sayad Shirazi Medical Center of Golestan Medical Sciences over 18 years of age, randomly, double-blind, placebo-controlled study will be included in the study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
mmHg120 <blood pressure <mmHg 160 (Pre- and stage 1 hypertension)
Age over 18, female or male
Voluntary participation in this clinical study and submission of written consent
Exclusion criteria:
Other heart diseases
Secondary blood pressure
Serum potassium> 5.5 mmol / L or <3.5 mmol / L
double Serum creatinine in the last 6 months
Severe complications of diabetes or serious macrovascular events within 6 months (e.g., cerebral hemorrhage, cerebral infarction, or acute myocardial infarction)
Recent infection in the last 4 weeks
Primary or secondary kidney disease (e.g., IgA nephropathy, membranous nephropathy, or lupus nephritis)
Any cancer and malignancy
Severe mental disorder
Pregnant or lactating women or women who are planning to become pregnant or women who are not using appropriate contraceptive methods
Participate in other clinical trials
Drug allergies or jujube allergies
Use of other herbal medicines to control the symptoms of the present disease
History of smoking, drugs
Other conditions that the researchers considered inappropriate in this clinical study
-
Intervention groups
-
Control group: routine drug treatment + placebo for 12 weeks
Intervention group: routine drug treatment + extract of Ziziphus jujuba fruit for 12 weeks
-
Main outcome variables
-
Blood pressure
General information
-
Reason for update
-
Change of sponsors of financial resources and delay in sampling time.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200506047325N1
Registration date:
2021-11-18, 1400/08/27
Registration timing:
prospective
Last update:
2023-02-27, 1401/12/08
Update count:
1
-
Registration date
-
2021-11-18, 1400/08/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-04-21, 1402/02/01
-
Expected recruitment end date
-
2024-04-20, 1403/02/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Investigation of antihypertensive effect of antioxidant enriched Ziziphus jujuba fruit extract in patients with primary hypertension: A randomized, double-blind, placebo controlled clinical trial
-
Public title
-
Evaluation of anti-hypertensive effect of jujube fruit
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
120 mmHg < blood pressure < mmHg 160 (Pre- and stage 1 hypertension)
Age over 18, female or male
Voluntary participation and written consent
Exclusion criteria:
Other heart diseases
Secondary blood pressure
Serum Potassium > 5.5 mmol/L or < 3.5 mmol/L
double serum creatinine in the last 6 months
Severe complications of diabetes or serious macrovascular events within 6 months (for example, cerebral hemorrhage, cerebral infarction, or acute myocardial infarction)
Recent infection in the last 4 weeks
Primary or secondary kidney disease (e.g., IgA nephropathy, membranous nephropathy, or lupus nephritis)
Any cancer and malignancy
Severe mental disorder
Pregnant or lactating women or women who are planning to become pregnant or women who are not using appropriate contraceptive methods
Drug allergies or jujube allergies
Participate in other clinical trials
Use of other herbal medicines to control the symptoms of the present disease
History of smoking, drugs
Other conditions that the researchers considered inappropriate in this clinical study
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
48
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The random assignment list will be computer generated with a 1:1 allocation, stratified by recruitment site, using random block size of four. Using concealed in sequentially numbered, sealed, opaque envelopes (SNOSE), participants will enter the blocks in such a way that an equal number of each assigned group. Allocation will be done by randomly selecting one of the arrangements and assigning the next part of the participants to the study groups according to the specified sequence. And kept by the hospital pharmacist of the center.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
To maintain blindness in patients, the drug and placebo are the same in shape and appearance; Also, the evaluator is not aware of the type of drugs in the intervention groups, so that multi-digit numerical codes are written on the drug packages that only the main person in charge of the research is aware of.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-10-31, 1400/08/09
-
Ethics committee reference number
-
IR.GOUMS.REC.1400.273
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
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Mercury sphygmomanometer
Secondary outcomes
1
-
Description
-
SCr
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood and urine tests
2
-
Description
-
eGFR
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood and urine tests
3
-
Description
-
Serum Albumin
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood and urine tests
4
-
Description
-
Serum Potassium
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood and urine tests
5
-
Description
-
EGC
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Electrocardiograph
6
-
Description
-
Liver enzymes
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood tests
7
-
Description
-
ACE2 enzyme
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Bloodtests
8
-
Description
-
Serum Nitric oxide
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood tests
9
-
Description
-
Lipid profiles
-
Timepoint
-
0: Start studying and receiving medication (in person),1: 2 weeks after receiving stage 1 medication (in person), 3: Week 8 End of stage 2 drug treatment course (in person), 4: Week 12 after receiving the drug stage 3 (face-to-face visit), 5: First follow-up - 2 weeks after receiving the drug (week 14) (telephone follow-up), 6: Second follow-up - 4 weeks after receiving the drug (week 16) (face-to-face visit)
-
Method of measurement
-
Blood tests
10
-
Description
-
diet
-
Timepoint
-
Before and after 12 weeks of intervention
-
Method of measurement
-
Diet with 24Recall checklist
Intervention groups
1
-
Description
-
Intervention group: Receiving routine drug treatment + enriched antioxidant extract of Ziziphus jujuba fruit for 12 weeks (3 months). Patients will be evaluated for symptoms at 14 weeks and 16 weeks after the end of the study.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Receiving routine drugs+ placebo for 12 weeks (3 months)
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Golestan University of Medical Sciences
-
Proportion provided by this source
-
50
-
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
2
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
South Khorasan Academic center for education, culture and research
-
Proportion provided by this source
-
33
-
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
3
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Food and Bio-Nanotech International Research Center (Fabiano)
-
Proportion provided by this source
-
33
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Industry
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is no more information.
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available