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Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on treatment of hypertension in patients with mild chronic kidney disease

Protocol summary

Study aim
Comparison of blood pressure changes in Hibiscus sabdariffa and thiazide groups in patients with chronic renal failure Sub-objectives: Comparison of albuminuria, proteinuria, hyperlipidemia and changes in sodium and potassium electrolytes and the progression of renal failure in the two groups of Hibiscus sabdariffa and thiazide in patients with chronic renal failure
Design
A clinical trial study with a control group, community-based and pragmatic, with parallel groups, double-blind, randomized by randomized block method, phase 3 on 64 patients
Settings and conduct
In the field of changes in blood pressure following the use of drugs in patients with hypertension, in the nephrology clinic of Sayad Shirazi Hospital, double-blind (patient and physician evaluating)
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years 2. Consent to participate in the study 3. A patient with clinical signs of hypertension with mild renal failure 4. Abnormal blood pressure (=> 130/80 according to AHA criteria) Exclusion criteria: 1- Allergy to herbal medicines 3- Patients with diabetes mellitus, severe renal failure, coronary artery disease, heart failure, malignant hypertension [BP ≥ 180/110], etc.) 4 - changing of antihypertensive drugs 5- Systolic blood pressure < 100 or => 160/100 7- Pregnancy 8. Any metabolic or malabsorption disease . 9- Use of psychiatric drugs
Intervention groups
1 .Valsartan + thiazide 2. Valsartan + hibiscus
Main outcome variables
During the course of the study, none of the participants will be deprived of the standard treatment required by each volunteer. If blood pressure drops or rises during treatment, patients will be excluded from the study and return to their original treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210926052600N1
Registration date: 2021-12-22, 1400/10/01
Registration timing: registered_while_recruiting

Last update: 2021-12-22, 1400/10/01
Update count: 0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Behdad ِDehkhoda
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 2030
Email address
forward.b1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
2021-09-21, 1400/06/30
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2023-02-19, 1401/11/30
Scientific title
Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on treatment of hypertension in patients with mild chronic kidney disease
Public title
Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on treatment of hypertension in patients with mild chronic kidney disease : A randomized controlled clinical trial: double blinded
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Non-pregnant man or woman 18 to 70 years old 2. Consent to participate in the study 3. A patient with confirmed clinical signs of hypertension with mild renal failure 4. Abnormal blood pressure (=> 130/80 according to AHA criteria) 5. Patient follow-up
Exclusion criteria:
1- Allergy to the plant 2- Normal blood pressure (mm HgSBP ≤ 120; DBP ≤ 80 mm Hg) / blood pressure below 100 and blood pressure => 160/100 3- Patients with diabetes mellitus, severe renal failure, coronary artery disease, heart failure, malignant hypertension [BP ≥ 180/110], etc.) 4- Study of changing antihypertensive drugs in patients 5- Systolic blood pressure below 100 during the study 6- Pregnancy 7. Any metabolic or malabsorption disease that may interfere with the absorption of hibiscus (such as celiac disease, chronic pancreatitis, etc.). 8- Use of psychiatric drugs (mood stabilizer, anti-depressant, anti-anxiety or anti-psychotic
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 64
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 32 of each letter A and B. According to the above block, 64 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 64. The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind, so that all patients and physicians evaluating the interventions designed in the study or the consequences after the intervention (assistant of internal medicine and nephrology and hypertension) will not be aware of the patient grouping. The drugs used will be available in similar form and packaging so that it is not possible for anyone to identify the study group during the study process.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, at the beginning of Shast Kola Road, Hyrkan Street
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.Goums.Rec.1400.229

Health conditions studied

1

Description of health condition studied
Patients with hypertension with mild renal failer
ICD-10 code
I12
ICD-10 code description
Hypertensive chronic kidney disease

Primary outcomes

1

Description
Patients' blood pressure changes,, albuminuria and proteinuria
Timepoint
Blood pressure at the beginning and 3 months after the intervention
Method of measurement
Based on laboratory Examination

2

Description
electrolytes
Timepoint
Electrolytes at the beginning and 3 months after the start of the intervention
Method of measurement
Based on laboratory Examination

3

Description
Albuminuria and proteinuria
Timepoint
albuminuria, proteinuria, GFR according to MDRD formula
Method of measurement
Based on laboratory Examination

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, 25 mg of hydrochlorothiazide tablets and 40 mg of valsartan tablets daily every 12 hours for 3 months
Category
Treatment - Drugs

2

Description
Control group: Control group: Group 2: 420 mg hibiscus tablets every 12 hours and 40 mg valsartan every 12 hours for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayad Shirazi Hospital, Gorgan
Full name of responsible person
Dr. Saeid Amirkhanloo
Street address
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2154
Email
Sayyadlib@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, at the beginning of Shast Kola Road, Hyrkan Street
City
gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1660
Email
mrhonarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Behdad Dehkhoda
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
City
gorgan
Province
Golestan
Postal code
74394917867
Phone
+98 17 3220 2154
Email
forwar.b1367@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Saeid Amirkhanloo
Position
استادیار
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
City
gorgan
Province
Golestan
Postal code
74394917867
Phone
+98 17 3220 2173
Email
drsam74ir@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Behdad Dehkhoda
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
City
Gorgan
Province
Golestan
Postal code
۷۴۳۹-۴۹۱۷۸۶۷
Phone
+98 17 3220 2154
Email
forward.b1367@gmail.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
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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