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

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855645
• Other study ID #: CMUH105-REC2-052
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 21, 2016
• Last updated: November 14, 2016
• Start date: July 2016

Study information

• Verified date: November 2016
• Source: China Medical University Hospital
• Contact: Ching-Liang Hsieh, M.D. , Ph.D
• Phone: +886-4-22053366
• Email: clhsieh[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Early diagnosis Type ? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Trichosanthes root
Trichosanthes root at a rate of 1.5 g two times per day for 84 days.
• Placebo
Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin A1c	Improvement of glycated hemoglobin A1c levels	Three months	Yes
Primary	Plasma Blood Sugar	Improvement of Plasma Blood Sugar levels	Three months	Yes