Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

NCT02161276 | Completed Phase 1 DMC

• 1 other identifier: TNTL-14-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Accidental Exposure While Preparing Drug for Administration

Outcome Measures

Primary Outcomes (1)

• The decline glycosylated hemoglobin A1C and blood glucose level

  Decline in Hemoglobin A1C and blood glucose level

  up to 8 weeks

Secondary Outcomes (1)

• The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants

  2 months

Study Arms (1)

TNTL capsule and Placebo

EXPERIMENTAL

3-4 capsules 3 times a day Used before meals

Drug: TNTL capsule; Drug: Placebo

Interventions

TNTL capsule DRUG

Patients were asked to taken drugs 3 times a day, with each time 3 grains

Also known as: Tang Ning Tongluo Capsule

TNTL capsule and Placebo

Placebo DRUG

Patients were asked to taken drugs 3 times a day, with each time 3 grains

TNTL capsule and Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guizhou Bailing Group Pharmaceutical Co Ltd: lead
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Tianyuan Hospital of Guiyang City

Guiyang, Guizhou, 550007, China

Location

Study Officials

• XY Xin, Dr.

  ICMJE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 11, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

CN (1)