NCT02855645

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

July 21, 2016

Last Update Submit

November 14, 2016

Conditions

Diabetes Mellitus

Keywords

Trichosanthes rootTraditional Chinese MedicineClinical trial

Outcome Measures

Primary Outcomes (2)

  • Glycated hemoglobin A1c

    Improvement of glycated hemoglobin A1c levels

    Three months

  • Plasma Blood Sugar

    Improvement of Plasma Blood Sugar levels

    Three months

Study Arms (2)

Trichosanthes root

EXPERIMENTAL

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

Drug: Trichosanthes root

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Trichosanthes rootDRUG

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

Trichosanthes root
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of ≦ 1500 mg / day.
  • Age ranged between 20 and 80 years (including).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ching-Liang Hsieh

    China Medical University Hospital

    STUDY CHAIR

Central Study Contacts

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

CONTACT

+886-4-22053366clhsieh@mail.cmuh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 4, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

TW(1)