Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Renal function index
研究概览
简要总结
To explore the clinical effect of Shenkang Decoction in chronic renal failure (CRF) patients with hemodialysis (HD).
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 52 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of western medicine meets the diagnostic criteria of chronic kidney failure in Internal Medicine
- •the diagnosis of TCM meets the diagnostic criteria of the disease in the Guiding Principles for Clinical Research of New Chinese Medicine.
- •The patient is over 18 years old,
- •can think independently and have civil conduct,
- •strictly follow the doctor's advice,
- •maintain stable condition and regular HD treatment.
排除标准
- •Patients with HD time of no more than three months, severe uncontrolled infection, other malignant diseases, heart, liver, brain, and digestive system dysfunction, mental diseases such as dementia or depression;
- •contraindications to HD or contraindications to the study (Shock or systolic blood pressure below 80mm/Hg, severe bleeding or a tendency to bleed, serious infection such as sepsis, or a blood-borne infection, advanced tumor, extremely debilitating or not cooperating with doctor)
- •drug allergy, chronic use of glucocorticoids, and immunosuppressants.
- •women during pregnancy or lactation.
研究组 & 干预措施
Control group
losartan tablets were taken orally (J20180054; Hangzhou Merck Pharmaceutical Co., Ltd.; specification 50 mg) at a dose of 50 mg per day. Furosemide was injected intravenously (TCM approved by H41021056; Suicheng Pharmaceutical Co., Ltd.; specification 20 mg: 2mL) at a dose of 100 mg per day. Uremic clearance granule was mixed with water and taken (Z20073256; Kangchen Pharmaceutical (Khorgos) Co., Ltd.; Specification 5 g) at a dose of 5 g at 6:00,12:00 and 10 g at 22:00 every day. Treatment lasted for 10 - 14 days.
干预措施: Shenkang decoction (Drug)
Treatment group
Shenkang decoction prescription: 15 g of semen cuscutae, herba epimedii and pericarpium arecae. 20 g of Eucommia ulmoides Oliv., radix astragali, codonopsis pilosula, salvia miltiorrhiza, tuckahoe, atractylodes macrocephala, Chinese yam, honeysuckle, polyporus umbellatus and dandelion. 15 g of safflower. 12 g of processed Fuzi. 10 g of Radix phytolaccae and sage. Golden cherry son 20 g and puzzle kernel 15 g were added to patients with frequent proteinuria and nocturia took. Yellow cypress 15 g was added to patients with damp-heat in lower-Jiao. The decoction pieces were purchased from the Traditional Chinese Medicine and Pharmacy Department of the First People's Hospital of Zunyi City. They were decocted by computer automatic decocting machine (model) and divided into 150 mL / bag, taken orally, once in the morning, noon and evening, 3 times / day, 1 bag / time, one pair a day. Treatment lasted for 10 - 14 days.
干预措施: Shenkang decoction (Drug)
结局指标
主要结局
Renal function index
时间窗: 8 min
The AU5800 fully automatic biochemical analyzer produced by Beckman Coulter Co., Ltd. was selected for renal function index determination. peripheral venous blood (3-5 mL) was extracted before and after treatment, and Cre and urea nitrogen were measured after centrifugation
TCM syndrome points
时间窗: 14 days
According to the relevant contents of the Clinical Guiding Principles of New Chinese Medicine13, clinical symptoms of shortness of breath, fatigue, anorexia, chills, abdominal fullness and distension, unsolid stool, and weak waist were evaluated.
Nutritional status index
时间窗: 14days
In patients, 3 mL of fasting venous blood was collected and given anticoagulant treatment. The total serum protein, serum albumin, hemoglobin, and total red blood cells were measured by Mindray automatic biochemical analyzer (model BS-280, Shenzhen Mindray Bio-Medical Electronics Co., LTD.).
Dialysis adequacy judgment index
时间窗: 14 days
The urea dynamic model was used to evaluate the overall urea clearance judgment of a single dialysis effect, and Kt / V was calculated according to the Daugirdas formula. Kt / V= -ln (BUN before dialysis / BUN after dialysis-0.008 t) + (4-3.5 BUN before dialysis /BUN after dialysis) ultrafiltration volume / dialysis body weight. Long-term dialysis components are protein catabolism rate (calculated by Gotch formula) and time-average urea concentration (calculated by Lowrie formula). Protein catabolism rate = 9.35G×0.29Vt.
Treatment efficiency
时间窗: 14 days
The efficacy of the two groups was compared with the TCM syndrome points and the biochemical examination indexes.
General physical examination
时间窗: 14 days
Including heart rate, blood pressure, breathing, pulse, and urine volume. Urine routine, blood routine, stool routine, liver and kidney function testing, and electrocardiogram monitoring.
次要结局
未报告次要终点
研究者
Wenfu Cao
Director
The First People's Hospital of Zunyi