The effect of Urtica Dioica leaf and Olive Leaf Composition on lowering of Blood Glucose and Lipids in Type II Diabetic Patients
Design
A randomized, double-blind, placebo-controlled phase 3 clinical trial with 30 patients in each group.
Settings and conduct
The study subjects will be non-insulin dependent type 2 diabetic patients from a private clinic and diabetes clinic of Razi hospital in Rasht, Guilan. All patients in the control group or the intervention group will be followed for two months. Fasting glucose, postprandial glucose, lipids, and glycosylated hemoglobin are measured before and the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1-Patients over 30 years old
2-Non-dependent -Insulin type 2 diabetes mellitus patients
3- Under treatment with oral glucose-lowering drugs
Exclusion Criteria
1- History of underlying heart Disease
2- Kidney Disease
3- Thyroid Disease
4- liver disease
5- Pregnancy or lactation
6- Insulin -dependent patients
Intervention groups
The intervention group will receive the herbal supplement in addition to the usual treatment.The control group will receive placebo in addition to the usual treatment.
The effect of diabetosit supplement (extract of nettle leaf and olive leaf) on blood glucose and lipid profile in type 2 diabetic patients
Public title
"'Effect of Diabetosit herbal supplement in treatment of Diabetes"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 30 years old
Under treatment with oral glucose-lowering drugs
Exclusion criteria:
Insulin dependent patients
History of heart disease or myocardial infarction
History of asthma and allergy to nettle
Hepatic insufficiency
Pregnancy or lactation
Thyroid diseases
Severe infection
Renal Insufficiency
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who have medical records in the clinic and hospital and eligible for participating in the study are numbered and then a random number will be found by using the" Randomizer Research" software. This number is multiply by the number of samples(30). This process is repeated to reach the total sample size in the study. We can make a block with two in one block (block size is two) with two possible sequences of AB to assign sample numbers equally to each group. Above the consent form of the participants are labeled letters A or B in each group (n = 30) and these forms are provided to the secretaries of clinics. An independent nurse prepares syrups with “drug A” and “drug B” and put them into boxes according to the allocation orders. These syrups cannot be distinguished because they contain the same colored liquid with the same volume. Syrups will be given to them after the consent is signed based on the letter mentioned above the form by clinic nurse. Secretaries, clinical caregivers and nurses have no information about the type of syrups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Main medication and placebo are coded in order to be double-blind. Clinical providers,clinicians and patients are unaware of the type of drug being offered. Both of case and control groups,will receive placebo or herbal oral solution as 20 ml pre-meal for 8 weeks in addition to the usual treatment. . Only in analyzing data each group will be identified.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
No 8, Nasim Ave, Deilaman Blvd, Golsar, Rasht
City
Rasht
Province
Guilan
Postal code
4163545851
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.GUMS.REC.1398.153
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Percentage of patients with Fasting blood sugar lower than 140 mg/dl
Timepoint
At baseline and 8 weeks after study
Method of measurement
Biochemical tests are carried out by the Selectra autoanalyser. Total cholesterol will be measured enzymatically using cholesterol esterase and cholesterol oxidase. HDL-C is measured after deposition of lipoproteins containing APO-B by phosphotungstic acid with the same enzymatic method of total cholesterol. Triglycerides will be carried out enzymatically using glycerol phosphate oxidase. LDL-C is measured in serum samples with triglyceride levels equal or less than 400 mg / dl using the Freidwald formula.
Secondary outcomes
1
Description
Blood pressure
Timepoint
At baseline and 8 weeks after
Method of measurement
Using mercury sphygmomanometer
Intervention groups
1
Description
Receiving herbal supplement Diabetosit made by Yasin Teb Gostar Co for 8 weeks, 20 cc, three times a day before meals. Ingredients of 1 Liter Diabetosit ُSupplement : 100 grams of dried nettle leaves extract and 100 grams of dried olive leaves extract in 1 liter olive oil.
Category
Treatment - Other
2
Description
Control group:will receive the usual treatment in addition to a solution similar to diabetosit ( new supplement) as the placebo.