Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus

Randomized，Double-blind，Dose Parallel Controlled, Multicentre Clinical Trail of Tang-min-Ling Pills and Placebo in Diabetes Mellitus(Liver-stomach Heat Retention Syndrome) (Phase Ⅲ)

This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Tang-min Lin pill

Detailed Description

Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time), placebo by 3 times every day for 12 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiang Su
    • Nan Jing, Jiang Su, China, 210029
      • TCM school of Jiang Su province
  • Liao Ning
    • Shen Yang, Liao Ning, China, 116600
      • Liaoning University of Traditional Chinese Medicine
  • Shang Hai
    • Shang Hai, Shang Hai, China, 200032
      • Shanghai University of Traditional Chinese Medicine
  • Tian Jin
    • Tian Jin, Tian Jin, China, 300193
      • Tian Jin traditional chinese medicine university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• initial treatment type 2 diabetic patient
• liver-stomach heat retention syndrome
• BMI ≥24kg/m2
• aged 30-65 years
• after screening stage(lifestyle intervention),Hba1C≥7.0%,FPG7.0-13.3mmol/L or PG2h>11.1mmol/L;
• voluntary signs the informed consent

Exclusion Criteria:

• have used anti-diabetes drug before more than 1 month
• used drug to control the blood sugar with 3 weeks
• diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month
• liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease
• SBP/DBP >160mmHg/100 mmHg
• serious chronic diabetic complication
• chronic stomach-intestine disease,bad condition of the whole body
• pregnancy,preparing to pregnant,or breast-feed stage women
• allergic to TCM component
• mental disease
• allergic habitus
• attending to other clinical test
• attended this test before
• bibulosity and/or mental active drug,drug abuse or depend
• usually change the working environment,unstable live environment,etc.which will complied the inclusion
• unstable dose or type of anti-hypertension drug
• taking the drug or health food which will change the body weight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: controlled group; Tang-min Lin analogue 6g,tid,po	Drug: Tang-min Lin pill; Tang-min Lin pill 6g,tid,treat 12 weeks.
EXPERIMENTAL: Tang-min Lin pill; Tang-min Lin pills 6g,tid,po	Drug: Tang-min Lin pill; Tang-min Lin pill 6g,tid,treat 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
glycosylated hemoglobin	0 and 12weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign	baseline and 12 week after treatment

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing Hospital; Liaoning University of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; Tianjin University of Traditional Chinese Medicine; Tianjin Tasly Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Wu S Tao, pro., Tian Jin university of tradtional chinese medicine; Study Chair: Lian F Mei, doctor, Guang'anmen Hospital of China Academy of Chinese Medical

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ANTICIPATED): June 1, 2010

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (ESTIMATE): March 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2010
• Last Update Submitted That Met QC Criteria: March 15, 2010
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: type 2 diabetes; Tang-min Lin pills; liver and stomach heat retention; Evaluate the safety and efficacy of Tang-min Lin pills
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2008L00307