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

Study Overview
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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.

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.

Official Title
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Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances and Associations Study Between Glucose and Lipid Metabolism Disturbances and Cardiovascular Risk Factors

Conditions
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Type2 Diabetes, Dyslipidemias

Intervention / Treatment
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* Drug: Jiangtang Tiaozhi recipe
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 70 years at the time of their consent; Diagnosed with type 2 diabetes; TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L; BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm; Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment; TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome; Signed informed consent. Exclusion Criteria: Type 1 diabetes, gestational diabetes, other special types of diabetes. Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month. 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.. Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts. Pregnant, preparing for pregnancy or lactation. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jiangtang Tiaozhi Recipe Group<br>Jiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. | Drug: Jiangtang Tiaozhi recipe<br>* The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)<br>|
| Active Comparator: Metformin Group<br>500mg metformin tablet per time, 3 times a day, take it with meals. | Drug: Metformin<br>* The metformin tablets (500mg) will be administrated.<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 12 weeks |  | 0 week, 12 weeks | 
| Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks |  | 0 week, 4 weeks, 8 weeks,12 weeks | 
| Change from Baseline Postprandial Blood Glucose at 12 weeks |  | 0 week, 12 weeks | 
| Change from Baseline Low Density Lipoprotein at 12 weeks |  | 0 week, 12 weeks | 
| Change from Baseline Triglyceride at 12 weeks |  | 0 week, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks |  | 0 week, 4 weeks, 8 weeks,12 weeks | 
| Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks |  | 0 week, 4 weeks, 8 weeks,12 weeks | 
| Change from Baseline Total Cholesterol at 12 weeks |  | 0 week, 12 weeks | 
| Change from Baseline High Density Lipoprotein at 12 weeks |  | 0 week, 12 weeks | 
| Change from Baseline TCM Symptom Score at 12 weeks |  | 0 week, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, dyslipidemias, Jiangtang Tiaozhi Recipe, randomized controlled trial