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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor:
Collaborator:
China-Japan Friendship Hospital
Information provided by (Responsible Party):
Guizhou Bailing Group Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier:
NCT02161276
First received: May 21, 2014
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Accidental Exposure While Preparing Drug for Administration
Drug: TNTL capsule
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes

Resource links provided by NLM:


Further study details as provided by Guizhou Bailing Group Pharmaceutical Co Ltd:

Primary Outcome Measures:
  • The decline glycosylated hemoglobin A1C [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Decline in Hemoglobin A1C

  • Decline in blood glucose level of the patients [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 108
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tang Ning Tongluo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02161276

Contacts
Contact: Wenshu Teng, M.D +868533412256

Locations
China, Guizhou
Tianyuan Hospital of Guiyang City Recruiting
Guiyang, Guizhou, China, 550007
Contact: Wenshu Teng, M.D    +868533412256      
Sponsors and Collaborators
Guizhou Bailing Group Pharmaceutical Co Ltd
China-Japan Friendship Hospital
Investigators
Study Director: XY Xin, Dr. ICMJE
  More Information

No publications provided

Responsible Party: Guizhou Bailing Group Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02161276     History of Changes
Other Study ID Numbers: TNTL-14-01
Study First Received: May 21, 2014
Last Updated: July 31, 2014
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014