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

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase

Unknown
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Tang-min Lin pill

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01087242
2008L00307

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

480 participants in 2 patient groups, including a placebo group

controlled group
Placebo Comparator group
Description:
Tang-min Lin analogue 6g,tid,po
Treatment:
Drug: Tang-min Lin pill
Tang-min Lin pill
Experimental group
Description:
Tang-min Lin pills 6g,tid,po
Treatment:
Drug: Tang-min Lin pill

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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