A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 主要终点
- Analysis of body mass index changes in 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria of metabolic syndrome;
- •TCM syndrome differentiation of spleen deficiency and dampness patients;
- •Patients with phlegm-dampness constitution score>30;
- •Patients aged 18 to 70 years;
- •Patients who have signed informed consent and are highly compliant.
排除标准
- •Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary metabolic syndrome (disease, drugs, surgery, etc.);
- •Patients with severe primary diseases such as heart, liver, kidney, lung, brain, endocrine, hematopoietic system in the past or at the time of enrollment;
- •Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and other serious heart diseases;
- •Patients with co-infection, malignant tumors or mental illness;
- •Patients with Cushing syndrome;
- •Patients with allergies or allergies to this drug;
- •Pregnant or breastfeeding women;
- •Those who have adjusted hypoglycemic, lipid-lowering, antihypertensive drugs or taking weight-loss drugs within 1 month before enrollment.
研究组 & 干预措施
Single decoction group: Wulingsan single decoction granules
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.
干预措施: Wulingsan single decoction granules (Drug)
Co-decocting group: Wulingsan co-decocting granules
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.
干预措施: Wulingsan co-decoction granules (Drug)
Powder group: Wuling powder powder
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.
干预措施: Wuling Powder (Drug)
Simulant group: Simulant of granular dosage form
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.
干预措施: Wulingsan granule simulant (Drug)
结局指标
主要结局
Analysis of body mass index changes in 12 weeks
时间窗: 12 weeks
Measure and record the patient's BMI before and after treatment
Analysis of changes in waist-to-hip ratio at 12 weeks
时间窗: 12 weeks
Measure and record the waist-to-hip ratio of the patient before and after treatment
次要结局
- Improvement of the conversion score of phlegm-damp constitution judgment(12 weeks)
- Lipid Index(4 weeks，8 weeks，12 weeks)
- Fasting blood glucose index(4 weeks，8 weeks，12 weeks)
- 2h blood glucose after meal(4 weeks，8 weeks，12 weeks)
- HOMAA insulin resistance index(12 weeks)
- Blood pressure index(4 weeks，8 weeks，12 weeks)
- Inflammatory factors(12 weeks)