Determining the effect of Hibiscus esculentus plant on blood sugar, hepatic and lipid profiles and insulin resistance in patients with diabetic type two
Design
This study is a multi-center double-blinded randomized control trial with placebo which is done on 66 patients with type two diabetic who refer endocrine disease clinics affiliated to Mazandaran University of Medical Sciences in Sari city.
Settings and conduct
The filed of the study includes the endocrine disease clinics affiliated to Mazandaran University of Medical Sciences in Sari city.
Participants/Inclusion and exclusion criteria
The study inclusion criteria include having type 2 diabetes at least three months before entering the study, Age between 20 and 80 years, Hemoglobin A1C more than 7.5 at time of entering the study. The exclusion criteria include unwillingness of the patient, obeying a diet regimen or special kind of exercise and known allergy to Hibiscus esculentus.
Intervention groups
The intervention and control groups use oral Hibiscus esculentus and placebo capsules respectively with the amount of two capsules three times in a day after breakfast, lunch, and dinner (6 capsules in total daily).
Main outcome variables
Fasting Blood Sugar, Hemoglobin A1c
General information
Reason for update
Acronym
EHBSLD
IRCT registration information
IRCT registration number:IRCT20180609040020N1
Registration date:2018-06-15, 1397/03/25
Registration timing:prospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Ali Hesamzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
a.hesamzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-07, 1397/04/16
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Hibiscus esculentus on blood sugar and lipids of patients with type 2 Diabetes: A double blind clinical trial
Public title
Effect of Hibiscus esculentus on blood sugar and lipids of Type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes at least three months before entering the study
Age between 20 and 80 years
Hemoglobin A1C more than 7.5 at time of entering the study
Using a contraceptive method in women during reproductive age who entered the study
Exclusion criteria:
Unwillingness of the patient
Having known Immune deficiency
Pregnancy and breastfeeding
Obeying a diet regimen or especial kind of exercise
Using supplements containing Hibiscus esculentus
Cardiovascular diseases
History of hepatic and renal diseases
Uncontrolled thyroid disease
History of diabetic ketoacidosis
Creatinine more than 2
Using drugs that have an effect on blood sugar level including Corticosteroids and thiazides
Known allergy to Hibiscus esculentus plant
Manifestation of acute physical problems during the intervention
Changing the type of treatment and manifestation of hypoglycemia symptoms
Severe Weight loss at least 10 percent during the past 6 months
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly assigned to two groups of intervention and control based on randomized block design. For the randomized assignment, each group is considered 4 persons in 4 conditions, therefore 6 conditions may happen: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The type of being intervention or control of A or B is determined by the statistical consultant. The color of capsules is similar for intervention and control group and the patients, clinical and outcome evaluators are unaware of the contents of the capsules and the way of patients’ assignment into two groups of intervention and control.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.1211
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
At the beginning of the intervention and at the end of intervention on the day 60
Method of measurement
Blood test
Secondary outcomes
1
Description
Hemoglobin A1C
Timepoint
En At the beginning of the intervention and at the end of intervention on the day 60
Method of measurement
Blood test
2
Description
Cholesterol
Timepoint
At the beginning of the intervention and at the end of intervention on the day 60
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: Type 2 diabetic patients who use powder of Hibiscus esculentus with the dose of 1000 milligrams three times daily before breakfast, lunch, and dinner for 60 days.
Category
Treatment - Drugs
2
Description
Control group: Type 2 diabetic patients who use two placebo capsules three times daily before breakfast, lunch, and dinner for 60 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba clinic
Full name of responsible person
Ali Hesamzadeh
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4817615793
Phone
+98 11 3324 0002
Email
a.hesamzadeh@mazums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Imam Hospital clinic
Full name of responsible person
Ali Hesamzadeh
Street address
Razi St.,
City
Sari
Province
Mazandaran
Postal code
3313148166
Phone
+98 11 3336 1700
Fax
+98 11 3337 0881
Email
a.hesamzadeh@mazums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Street address
Valieasr Blvd.
City
Sari
Province
Mazandaran
Postal code
3397148157
Phone
+98 11 3304 4001
Email
a.hesamzadeh@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Laleh St.
City
Sari
Province
Mazandaran
Postal code
4817914934
Phone
+98 11 3321 9437
Email
a.hesamzadeh@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Laleh St.
City
Sari
Province
Mazandaran
Postal code
4817914934
Phone
+98 11 3321 9437
Email
a.hesamzadeh@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Hesamzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Laleh St.
City
Sari
Province
Mazandaran
Postal code
4817914934
Phone
+98 11 3321 9437
Email
a.hesamzadeh@mazums.ac.ir
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