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

Hemodialysis Clinical Trial

Official title:

Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631782
• Other study ID #: Caowenfu590
• Status: Completed
• Phase: Early Phase 1
• Start date: November 10, 2020
• Est. completion date: December 26, 2021

Study information

• Verified date: November 2022
• Source: The First People's Hospital of Zunyi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 26, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 52 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hemodialysis
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Shenkang decoction
Given Shenkang decoction on the basis of the above treatment. 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.

Locations

Country	Name	City	State
China	The First People's Hospital of Zunyi	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Zunyi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function index	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	8 min
Primary	TCM syndrome points	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.	14 days
Primary	Nutritional status index	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.).	14days
Primary	Dialysis adequacy judgment index	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.	14 days
Primary	Treatment efficiency	The efficacy of the two groups was compared with the TCM syndrome points and the biochemical examination indexes.	14 days
Primary	General physical examination	Including heart rate, blood pressure, breathing, pulse, and urine volume. Urine routine, blood routine, stool routine, liver and kidney function testing, and electrocardiogram monitoring.	14 days