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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

NCT01107171

Diabetes Mellitus, Type 2

COMPLETED PHASE2

Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule

NCT02161276

Accidental Exposure While Preparing Drug for Administration

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

NCT04889157

Diabetes Mellitus, Type 2

COMPLETED PHASE1

Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes

NCT04797442

Obese Overweight Type 2 Diabetes

UNKNOWN PHASE2

The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

NCT07198516

NAFLD Diabete Type 2

NOT_YET_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

controlled group

Tang-min Lin analogue 6g,tid,po

Group Type PLACEBO_COMPARATOR

Tang-min Lin pill

Intervention Type DRUG

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

Tang-min Lin pill

Tang-min Lin pills 6g,tid,po

Group Type EXPERIMENTAL

Tang-min Lin pill

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tang-min Lin pill

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No