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In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.
The research purpose of this project is to observe the effectiveness and safety of Wulingsan single decoction granules compared with traditional powder, co-decoction granules and analogues in the treatment of metabolic syndrome in combination with conventional therapies. ; Compared with Wulingsan traditional powder and co-decoction granule group, observe the effectiveness and safety of traditional powder combined with conventional therapy in the treatment of metabolic syndrome. The trial adopts a randomized, partially double-blind, controlled, multi-center clinical research method. A total of 320 cases were included in 4 groups, namely, single decoction group, co-decoction group, powder group, and simulated agent group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and the observation period is set to 12 weeks. Follow up every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single decoction group: Wulingsan single decoction granules | Experimental | Wulingsan single decoction granules, Alisma orientalis (15g), Polyporus (10g), Baizhu (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. |
|
| Co-decocting group: Wulingsan co-decocting granules | Other | Wulingsan co-decoction granules, Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. |
|
| Powder group: Wuling powder powder | Other | Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. Take 5g each time with warm water twice a day.Take 12 weeks as a course of treatment. |
|
| Simulant group: Simulant of granular dosage form | Placebo Comparator | Granule simulant, the composition is Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day. Take 12 weeks as a course of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wulingsan single decoction granules | Drug | Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of changes in waist-to-hip ratio at 12 weeks | Measure and record the waist-to-hip ratio of the patient before and after treatment | 12 weeks |
| Analysis of body mass index changes in 12 weeks | Measure and record the patient's BMI before and after treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the conversion score of phlegm-damp constitution judgment | To study the improvement of the conversion score of phlegm-damp constitution before and after treatment | 12 weeks |
| Lipid Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Shu, PhD | Contact | 86-13961701999 | Lushu@medmail.com.cn |
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| Wulingsan co-decoction granules | Drug | Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water |
|
| Wuling Powder | Drug | Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water |
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| Wulingsan granule simulant | Drug | Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water |
|
Investigate the changes in triglycerides, high-density lipoprotein cholesterol, cholesterol and low-density lipoprotein cholesterol during treatment
| 4 weeks,8 weeks,12 weeks |
| Fasting blood glucose index | Investigate changes in fasting blood glucose during treatment | 4 weeks,8 weeks,12 weeks |
| 2h blood glucose after meal | Investigate changes in 2h blood glucose after meal during treatment | 4 weeks,8 weeks,12 weeks |
| HOMAA insulin resistance index | To investigate the changes of HOMAA insulin resistance index during treatment | 12 weeks |
| Blood pressure index | Observe the changes in systolic and diastolic blood pressure during treatment | 4 weeks,8 weeks,12 weeks |
| Inflammatory factors | Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment | 12 weeks |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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