Investigation of antihypertensive effect of antioxidant enriched Ziziphus jujuba fruit extract in patients with primary hypertension: A randomized, double-blind, placebo controlled clinical trial
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
Acronym
IRCT registration information
IRCT registration number:IRCT20200506047325N1
Registration date:2021-11-18, 1400/08/27
Registration timing:prospective
Last update:2021-11-18, 1400/08/27
Update count:1
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Ayesheh Enayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1434
Email address
enayati_phyto@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Golestan University of Medical Sciences
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Ischemic Disorders Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr. Ayesheh Enayati
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Fax
+98 17 3245 1434
Email
enayati_phyto@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Ayesheh Enayati
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1434
Email
enayati_phyto@yahoo.com
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
Name of organization / entity
Niak Pharmaceutical Company
Full name of responsible person
Dr. Ayesheh Enayati
Street address
3th Floor of Brilliant Mall, Pasdaran Ave.
City
Gorgan
Province
Golestan
Postal code
49175/596
Phone
+98 17 3222 9229
Email
enayati_phyto@yahoo.com
Web page address
https://niakpharma.com/index.php/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Niak Pharmaceutical Company
Proportion provided by this source
50
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
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Ayesheh Enayati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Email
enayati_phyto@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Ayesheh Enayati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Email
enayati_phyto@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Ayesheh Enayati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 1434
Email
enayati_phyto@yahoo.com
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