Comparing the efficacy of Hibiscus sabdariffa with thiazide on reducing the amount of albuminuria in patients with type 2 diabetes
Design
Clinical trial with two intervention groups, with parallel groups, double-blind, randomized block design, phase 2 on 128 patients.
Settings and conduct
Each patient in the first group will receive 25 mg of hydrochlorothiazide tablets and 40 mg of valsartan tablets every 12 hours, and in the second group, 420 mg of hibiscus tablets every 12 hours in the morning and at night and 40 mg of valsartan every 12 hours in the two groups with similar packaging. and the patients and the doctor evaluating the interventions do not know the type of medicine received.
At the beginning of the study, the patients were randomly placed in the above two groups; GFR, fasting blood sugar, HgA1C, 24-hour urine protein and albumin, creatinine, TG CHOLESTEROL LDL HDL and blood pressure before and after the intervention (within a period of 3 months) are checked and compared. In addition, they will be monitored weekly during the first month and over the phone by the doctor and the project manager in terms of possible side effects.
Participants/Inclusion and exclusion criteria
Age 40 to 70 years
A patient diagnosed with type 2 diabetes
Blood pressure higher than 130.80 mm Hg
Follow up and continue the treatment of the patient and visit the clinic
Intervention groups
Group A: group receiving ARBs (angiotensin II receptor blockers) + thiazide (hydrochlorthiazide 25 mg daily)
Group B: group receiving ARBs + hibiscus (Hyporex-B tablets 420 mg twice a day)
Main outcome variables
albuminuria; GFR, blood pressure and lipid profile and FBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200522047538N1
Registration date:2022-09-26, 1401/07/04
Registration timing:registered_while_recruiting
Last update:2022-09-26, 1401/07/04
Update count:0
Registration date
2022-09-26, 1401/07/04
Registrant information
Name
Maryam Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3432 3594
Email address
kiani.m94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on albuminuria in patients with type 2 diabetes
Public title
Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on albuminuria in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40 to 70 years old2 Man or Non-pregnant woman
Provide conscious written and verbal consent
The patient should be admitted to the clinic with a diagnosis of type 2 diabetes confirmed
Blood pressure above 130/80 mm Hg
The person is willing and able to follow the study instructions and go to the clinic for a visit.
Exclusion criteria:
Allergic to the plant
Normal blood pressure (mm HgSBP ≤ 120; DBP ≤ 80 mm Hg)
Stage two and above
Patients with renal failure, coronary artery disease, heart failure .Pregnancy
Any metabolic or malabsorption disease that may interfere with the absorption of hibiscus (such as celiac disease, chronic pancreatitis, etc.).
Taking psychiatric medications (mood stabilizer, antidepressant, anti-anxiety or antipsychotic)
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be assigned to the experimental and control groups using the randomized block method. For random allocation using blocks of 4, first by throwing 32 regular hexagons, a random sequence of 32 blocks of 4 will be generated from among the following blocks:
AABB-ABAB-ABBA-BAAB-BABA-BBAA
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients and doctors evaluating the interventions designed in the study or the outcomes after the intervention (internal medicine assistant and nephrology and blood pressure subspecialist) will not know about the group in which the patient is examined. All interventions in both groups will be designed similarly and the procedure will be the same on all samples in all groups. The drugs used will also be supplied in the same form and packaging so that it is not possible 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 President of Research, Golestan University of Medical Sciences, the beginning of Shast Kala Road, Hirkan Blvd., Gorgan
City
Gorgan
Province
Golestan
Postal code
۴۹۳۴۱۷۴۵۱۵
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.GOUMS.REC.1401.264
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08.2
ICD-10 code description
Diabetes mellitus due to underlying condition with kidney complications
Primary outcomes
1
Description
urinary albumin
Timepoint
Albuminuria before the intervention and 3 months later
Method of measurement
Using a 24-hour urine collection test and examining the amount of protein and albumin excretion
Secondary outcomes
1
Description
blood pressure
Timepoint
Blood pressure with a sphygmomanometer before the start of the intervention and three consecutive weeks after the start of the intervention and after the end of the intervention
Method of measurement
Blood pressure measurement is performed by an experienced and trained technician who is unaware of the intervention, in a blinded manner. According to the Kaplan protocol, the blood pressure of the patients after at least 5 minutes of rest in a sitting position for three consecutive weeks at a certain hour by It is measured by an experienced and trained technician. For this measurement, Richter's Nova model desktop mercury pressure gauge is used.
Intervention groups
1
Description
Intervention group: 25 mg hydrochlorothiazide tablets daily and 40 mg valsartan tablets every 12 hours
Category
Treatment - Drugs
2
Description
Intervention group: 420 mg hibiscus tablet every 12 hours morning and night
Ethics Committee of the Vice Chancellor for Research and Technology, 3rd Floor, School of Dentistry, Golestan University of Medical Sciences, Shast Kola Road, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4915663158
Phone
+98 17 3245 0021
Fax
Email
tahghighat.g@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
Dr.Maryam Kiani
Position
Specialist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
2nd floor, 1st apartment, 12th Sardar street, Jangal street
2nd floor, 1st apartment, 12th Sardar street, Jangal street
City
Kordkoy
Province
Golestan
Postal code
4881864747
Phone
+98 17 3432 3594
Email
kiani.m94@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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Dr. Maryam Kiani
Phone number :00989113778569
Email: kiani.m94@gmail.com
What processes are involved for a request to access data/document
The applicant should provide his / her study file and the purpose of receiving the data in the form of an email with his / her research file (research plan), then after 3 months the file will be provided to the person