EXECUTIVE SUMMARY
CLINICAL TRIAL IN TREATING TYPE 2 DIABETES INSULIN RESISTANCE
BY
BIO-G R&D CENTRE
In collaboration with AIFA Health
Period test: 6 years

ESULIN - Diabetes Herbs
note:

Esulin - name approved for Malaysia market;

OBJECTIVE:
A research on Esulin herb has been done for years to prevent and cure the complications of patients with type 2 diabetes.

RESEARCH DESIGN AND METHOD:
A double blind study was performed on 20 patients with type 2 diabetes divided into 2 groups of 10 patients that received either an oral supplementation of placebo or “Esulin” herb for 12 weeks. Before the treatment, all patients will be measured on their blood sugar, cholesterol level, BMI and complications of the type 2 Diabetes.

Results:
The herb treatment obviously improved of blood sugar, total cholesterol, obesity, sensitivity of body cells to insulin. (P<0.01)

Conclusion:
The Herbs are able to improve complications of Type 2 Diabetes.

Introduction
Based on these observations, we carried out a study on patients with type 2 diabetes and other complications where Herb was administered to prevent, cure and enhance the immune system of the patients. A very obvious result was collected and clinical trial has been done to these patients.

Research Design and methods-
1.1) It was a randomized, double blind, placebo controlled small scale study of average 6.9 years. Total patients 20 people (male=11, female=9) age range 35-75years old, median age = 55.8 years old.

1.2) All patients have given written informed consent; fulfill the standard of WHO 1999 for diabetic type 2. They were not patients with diabetes type 1, had no other complications. The eligible patients should be (1) diabetes type 2, (2) followed diet control; exercise; diet control + exercise + lower blood sugar {7mmol/l < before meal < 8.3mmol/l} or {11.1 mmol/l < after meal 2 hours< 13.9mmol/l}, (3) age range 30-75 years old. (4) Patients underwent diabetes type 2 more than 3 month times.
Dropout cases: Patients using insulin; lactating women; allergic to herb; irresponsible patients (not follow diet control and herb intake); serious heart, liver, kidney, brain and nerve problem; blood pressure up to180/110mmHg;

1.3) During treatment time, the patients were given 0.5g herb/capsule, took orally before meal, 2-3 capsules/time, 3 times/ day. The whole duration of treatment need around 3 months time.

Result will be compared between placebo with patients taken the herbs. All the subjects were following a diet for diabetic patients without changing their food habits for the whole duration of the study. These patients still have to take the medicine given by their doctor except the lower cholesterol medicine. The patients have to undergo a washout for 2 weeks. After taking all their standard measurements, the subjects will start given the herb capsule. They will be measured after 4 weeks, 8 weeks, and 12 weeks.

1.4) Observative measurement
Before the washout: Fasting blood glucose(FBG), 2 hours after meal blood glucose(P2hBG), HbA1C, body mass index(BMI), body check-up for ( blood test, urine test, pass motion, liver function, kidney function, mammography).After taking the herb capsule for 12 weeks: FBG, P2hBG, HbA1c, FINS, blood cholesterol, measurement on insulin resistant, insulin allergic, FIG, BMI and the body check-up(same as before the washout).

Measurement after taking herbs capsule for 4 weeks, 8 weeks: FBG, P2hBG, BMI
Insulin allergic formula: IAI=1/(FINS x FBG)
Against Insulin intake: HCMA-IR= FINS x FBG/22.5

1.5) Data analysis
All data in text and figures are provided as medians ± standard. Statistical significance was tested using SPSS10.0.

Result
Table 1: measurements on before and after treatment of FBG, FINS, HCMA-IR, IAI, BMI (x±S)

Comparison before stop taking lower cholesterol medicine to before treatment, (P>0.05)
Comparison before treatment to after treatment, (P<0.01-0.05)  

Table 2: measurements on before and after treatment of HbA1C, C, TG, FIG (x±S)

Comparison before stop taking lower cholesterol medicine to before treatment,(P>0.05)
Comparison before treatment to after treatment, (P<0.01-0.05) 

Table 3 : measurements on before and after treatment (x±S)

Comparison before treatment to after treatment, (P>0.05; # P<0.01; ##P<0.05) 

 Table 4: measurements on before and after treatment (N=20)

Comparison before treatment and after treatment, P<0.01

Discussion

Type 2 Diabetes may account for 90% to 95% of all diagnosed cases of diabetes and is a progressive disease that, in many cases, is present long before it is diagnosed. Hyperglycemia develops gradually and is often not severe enough in the early states for the patient to notice any of the classic symptoms of diabetes. Although undiagnosed, these individuals are at increased risk of developing macro vascular and micro vascular complications. In most cases, type 2 diabetes results from a combination of insulin resistance and beta- cell failure. Risk factors for type 2 diabetes include genetic and environmental factors, including family history, obesity particularly intra-abdominal obesity, physical inactivity, older age, a prior history of gestational diabetes, impaired glucose homeostasis and race or ethnicity.

For this moment, the treatments for diabetic type 2 are to control diet + increase physical activity + oral glucose lowering medicine + insulin sensitizers. But the insulin sensitizers not satisfied enough due to high risk of taking the insulin sensitizers, the clinical trials done on the medicine not showed very good results, long term taking it will cause reduced function of pancreas. At the same time, the side effects of the medicine and financial burden on family members also a big influence. 

A Research conclude that, the improvement on the organs like liver, pancreas, improve the blood circulation, enhance the internal energy, balance between the positive and “ negative our body will improve the complications of Insulin resistant.

Our researchers using very advanced technology to do the extraction for all the herbs to produce a good combination formula “Esulin.  The result shown that the formula was very effectively improve the complications of Diabetic type 2: high blood glucose, high cholesterol, and obesity. After the first session (12 weeks), the orally intake of glucose lowering medicine also reduced. But the patients’ blood glucose and the level of HbA1C still maintained in standard level, and all the complications of the Insulin resistant also reduced. For the obvious symptoms like tiredness, no energy, lazy to talk and move, mouth dry, thirsty, hungry, frequent urination, heat, sweating a lot, angina, numbness, whole body also obviously reduced.

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