Investigation of the effect of oral consumption of Salvadora persica extract on the signs and symptoms of diabetes and other systemic symptoms
Design
A clinical trial with a control group, with parallel groups, triple-blind, randomized, phase 2, on 120 patients in 3 groups, for 8 weeks, will be treated with oral drug syrup (150 or 300 mg) or placebo twice a day, 5 cc each time. A table of random numbers will be used for randomization.
Settings and conduct
This study will be performed on patients with active records in the diabetes clinic of Sedigheh Tahereh Medical Center in Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having type 2 diabetes in the last 10 years; Age 60-30 years; 5/6 ≥ HbA1c ≥ 5/7; Patient consent to participate in the project.
Exclusion criteria:
Pregnancy and lactation; Consumption of injectable drugs for lowering blood sugar (types of injectable insulin) and oral drugs from the category of sulfinyl urea; Kidney or liver failure.
Intervention groups
Three groups of patients: drug group with a dose of 300 mg per day and drug group with a dose of 600 mg per day and placebo group
Main outcome variables
BMI ; FBS ; HbA1c ; Homa IR ; TC ; TG ; LDL ; HDL ; AST ; ALT ;
Constipation, urinary, skin, gastrointestinal and neurological symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210906052392N1
Registration date:2021-10-20, 1400/07/28
Registration timing:registered_while_recruiting
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
Akram Izadikhah najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3448 4777
Email address
a.izadikhah@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-08, 1400/07/16
Expected recruitment end date
2022-10-08, 1401/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of Salvadora persica extract on blood sugar and lipid profile in diabetic patients (type2)
Public title
Study of the effects of Salvadora persica extract on blood sugar and lipid profile in diabetic patients (type2)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes in the last 10 years
Age 60-30 years
HbA1c between 5.6 to 7.5
Patient consent to participate in the project
Exclusion criteria:
Pregnancy or breastfeeding
Use of injectable hypoglycemic drugs (injectable insulin) and oral sulfonylureas
Renal or liver failure
Age
From 35 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done by easy sampling method.
In this study, random allocation will be done by Stratified Permuted Blocked Randomization (by age-sex subgroups). In this method, eligible individuals with inclusion criteria will be selected and then they will be randomly divided into three groups of interventions and controls using three blocks. Finally, a table with 4 columns for men over 50, men under 50, women over 50, women under 50, each column in the rows containing the letters A, B, C randomly for three study groups. At the beginning of the patients' arrival, if the entry conditions are met, according to their age and gender, it is placed in a column and according to the English letters, it is placed in one of the study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, neither the patient nor the researcher nor the analyzer knew in which intervention group or placebo. Patients are divided into three groups A, B, C. Drugs are also in three categories A, B, C that are assigned to patients. The analyzer does not know which group of patients will receive medication or placebo until the end of the analysis of the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee Isfahan University of Medical Sciences, School of Medicine
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.MUI.MED.REC.1400.489
Health conditions studied
1
Description of health condition studied
Diabetes melitus type 2
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
2
Description
triglyceride, Cholesterol, HDL
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
3
Description
Homa IR
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
4
Description
AST, ALT
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
5
Description
HbA1c
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
6
Description
BMI
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
medical lab
7
Description
Constipation score
Timepoint
Before the start of the study, the end of 8 weeks of intervention
Method of measurement
Using the WEXNER questionnaire
8
Description
Gastrointestinal symptoms score
Timepoint
Before the start of the study, the end of 8 weeks of intervention