Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2024-06-30

Brief Summary

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This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.

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Detailed Description

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The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.

Conditions

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Type2 Diabetes Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Jiangtang Tiaozhi Recipe Group

Jiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals.

Group Type EXPERIMENTAL

Jiangtang Tiaozhi recipe

Intervention Type DRUG

The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)

Metformin Group

500mg metformin tablet per time, 3 times a day, take it with meals.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

The metformin tablets (500mg) will be administrated.

Interventions

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Jiangtang Tiaozhi recipe

The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)

Intervention Type DRUG

Metformin

The metformin tablets (500mg) will be administrated.

Intervention Type DRUG

Other Intervention Names

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Glucophage

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 to 70 years at the time of their consent;
2. Diagnosed with type 2 diabetes;
3. TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L;
4. BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm;
5. Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;
6. TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome;
7. Signed informed consent.

Exclusion Criteria

1. Type 1 diabetes, gestational diabetes, other special types of diabetes.
2. Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.
3. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.
4. Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc..
5. Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.
6. Pregnant, preparing for pregnancy or lactation.
7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies.
8. According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No