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

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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Chronic Renal Failure
• Intervention / Treatment: Drug: Shenkang decoction

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Zunyi, China
    • The First People's Hospital of Zunyi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Treatment efficiency	The efficacy of the two groups was compared with the TCM syndrome points and the biochemical examination indexes.	14 days
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

Collaborators and Investigators

• Sponsor: The First People's Hospital of Zunyi

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): December 26, 2021

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: Caowenfu590

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No