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

NCT ID: NCT02855645

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Keywords

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Trichosanthes root Traditional Chinese Medicine Clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trichosanthes root

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

Group Type EXPERIMENTAL

Trichosanthes root

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Trichosanthes root

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Liang Hsieh

Role: STUDY_CHAIR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ching-Liang Hsieh, M.D., Ph.D

Role: CONTACT

Phone: +886-4-22053366

Email: [email protected]

Facility Contacts

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Ching-Liang Hsieh, professor

Role: primary

Other Identifiers

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CMUH105-REC2-052

Identifier Type: -

Identifier Source: org_study_id