Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule (TNTL)

Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes

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

Study Overview

• Status: Completed
• Conditions: Accidental Exposure While Preparing Drug for Administration
• Intervention / Treatment: Drug: TNTL capsule; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550007
      • Tianyuan Hospital of Guiyang City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
2. Age between 18-70 years.
3. 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%.
4. Traditional Chinese medicine symptom score ≥ 4 points.
5. Participated in the experiment voluntarily, and signed the informed consent form.

Exclusion Criteria:

1. Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
2. 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.
3. Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
4. ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
5. Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
6. Pregnant, lactating women and prepare for pregnancy.
7. The allergic constitution and the drug allergy known composition.
8. For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
9. within the past 3 months, participated in the other drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNTL capsule and Placebo; 3-4 capsules 3 times a day Used before meals	Drug: TNTL capsule; Patients were asked to taken drugs 3 times a day, with each time 3 grains; Other Names: Tang Ning Tongluo Capsule; Drug: Placebo; Patients were asked to taken drugs 3 times a day, with each time 3 grains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
• Collaborators: China-Japan Friendship Hospital
• Investigators: Study Director: XY Xin, Dr., ICMJE

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: TNTL-14-01