The Effects of Trichosanthes Root on Blood Sugar in Patients With Diabetes Mellitus

China Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Trichosanthes root; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02855645

CMUH105-REC2-052

Details and patient eligibility

About

Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen, According to traditional Chinese writing record that Trichosanthes root has the action of downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes root may lower blood sugar levels in the modern study. The investigators designed a double blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar were divided into treatment and control groups, and each group was 30 patients. In the treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g, bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root treatment. The investigators predict the results of the present study indicated that Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Early diagnosis Type Ⅱ Diabetic patients who Glycated hemoglobin A1c level between 7.0% and 9.0% (including) , and after three months of diet and exercise control.
2. The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of ≦ 1500 mg / day.
3. Age ranged between 20 and 80 years (including).

Exclusion criteria

1. Pregnancy or breast-finding.
2. Allergy to test medicine.
3. Type I Diabetic patients.
4. Bleeding tendency.
5. The participants who suffered from serious disorders, such as congestive heart failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure, cancer or stroke etc.
6. Irritable or anxious patients who cannot be assessed.
7. Refuse to sign the agreement.
8. The values of SGOT and SGPT levels were more than normal limit triple, or the value of creatinine level was more than normal limit.
9. Plasm glucose(Glucose AC) level in fasting state ≧ 300 mg / dL.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Trichosanthes root

Experimental group

Description:

Trichosanthes root at a rate of 1.5 g two times per day for 84 days.

Treatment:

Drug: Trichosanthes root

Placebo

Placebo Comparator group

Description:

Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.

Treatment:

Drug: Placebo