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)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01087242

Enrollment

480

Registered

2010-03-16

Start date

2009-05-31

Completion date

2010-06-30

Last updated

2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills

Brief summary

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.

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.

Interventions

DRUGTang-min Lin pill

Tang-min Lin pill 6g,tid,treat 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
glycosylated hemoglobin	0 and 12weeks after treatment

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026