Clinical Trials for the Optimal Dosage of Tang Ning Tongl... | NCT02161276

Studies
Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

NCT02161276

Sponsor

Guizhou Bailing Group Pharmaceutical Co Ltd

Status

Completed

Last Update Posted

Sep 11, 2014Estimated

Enrollment

110Actual

Phase

Phase 1Phase 2

Conditions

Accidental Exposure While Preparing Drug for Administration

Interventions

TNTL capsule
Placebo

Countries

China

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 11, 2014Estimated

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

Sep 10, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Name	Class
China-Japan Friendship Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.

aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus.

---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes

Detailed Description

Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TNTL capsule and Placebo	Experimental	3-4 capsules 3 times a day Used before meals	Drug: TNTL capsule Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TNTL capsule	Drug	Patients were asked to taken drugs 3 times a day, with each time 3 grains	TNTL capsule and Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The decline glycosylated hemoglobin A1C and blood glucose level	Decline in Hemoglobin A1C and blood glucose level	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants	Routine check for blood, urine, stool + occult blood, liver function (ALT, AST, AKP, GGT, TBIL), renal function (BuN, Cr), ECG before treatment with 1 times per week.	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
Age between 18-70 years.
The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%.
Traditional Chinese medicine symptom score ≥ 4 points.
Participated in the experiment voluntarily, and signed the informed consent form.

Exclusion Criteria:

Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine.
Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
Pregnant, lactating women and prepare for pregnancy.
The allergic constitution and the drug allergy known composition.
For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
within the past 3 months, participated in the other drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided