The Effects of Trichosanthes Root on Blood Sugar in Patie... | NCT02855645

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

NCT02855645

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

Nov 16, 2016Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Diabetes Mellitus

Interventions

Trichosanthes root
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

Not provided

First Submitted Date

Jul 21, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2016

Last Update Posted Date

Nov 16, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Trichosanthes root	Drug	Trichosanthes root at a rate of 1.5 g two times per day for 84 days.	Trichosanthes root

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycated hemoglobin A1c	Improvement of glycated hemoglobin A1c levels	Three months
Plasma Blood Sugar	Improvement of Plasma Blood Sugar levels	Three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ching-Liang Hsieh, M.D., Ph.D	Contact	+886-4-22053366	3500	clhsieh@mail.cmuh.org.tw

Overall Officials

Name	Affiliation	Role
Ching-Liang Hsieh	China Medical University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taichung		404	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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