Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients

The First People's Hospital of Zunyi

Status and phase: Completed; Early Phase 1

Conditions: Hemodialysis; Chronic Renal Failure

Treatments: Drug: Shenkang decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT05631782

Caowenfu590

Details and patient eligibility

About

To explore the clinical effect of Shenkang Decoction in chronic renal failure (CRF) patients with hemodialysis (HD).

Enrollment: 160 patients

Sex: All

Ages: 52 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Shenkang decoction

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Shenkang decoction