The Clinical Research of Traditional Chinese Medicine Formula

NCT07746219 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: KY-2025-401
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study examines the efficacy and safety of Bushen Huoxue Simiao formula for tonifying the kidneys and promoting blood circulation in treating postoperative complications of upper urinary tract stones, thereby providing evidence-based medical evidence and treatment strategies for clinical practice.

Conditions

Urologic Injuries; Kidney Disease

Keywords

Traditional Chinese Medicine; Renal Fibrosis; Renal Stone

Outcome Measures

Primary Outcomes (1)

• Urinary System Symptom Questionnaire (USSQ).

  The Urinary System Symptom Questionnaire (USSQ) is used to assess urinary symptoms and quality of life. Score Range: The total score ranges from \[0\] to \[100\] .Interpretation: Higher scores indicate more severe urinary symptoms and worse quality of life.

  Baseline and 4 weeks after treatment

Secondary Outcomes (3)

• Incidence of Abnormal Urinalysis Results

  Baseline and 4 weeks after treatment

• Serum Creatinine (SCr) Level

  Baseline and 4 weeks after treatment

• Blood Urea Nitrogen (BUN) Level

  Baseline and 4 weeks after treatment

Other Outcomes (1)

• Traditional Chinese Medicine (TCM) Syndrome Score

  Time Frame: Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

control group

OTHER

The control group received standard treatment (postoperative anti-infective therapy, fluid replacement, hemostasis, antispasmodic and analgesic therapy, and other symptomatic treatments)

Drug: Bushen Huoxue Simiao Formula

Bushen Huoxue Simiao Formula group

EXPERIMENTAL

Bushen Huoxue Simiao Formula

Other: control group

Interventions

Bushen Huoxue Simiao Formula DRUG

Patients in this group will receive Bushen Huoxue Simiao Formula (oral Chinese herbal decoction) in addition to standard basic therapy. The dosage is one dose per day, divided into two packets, taken orally twice daily (30 minutes after breakfast and dinner). The herbal medicine is supplied by Zhejiang Sanxitang Traditional Chinese Medicine Co., Ltd.

control group

control group OTHER

The control group received standard treatment (postoperative anti-infective therapy, fluid replacement, hemostasis, antispasmodic and analgesic therapy, and other symptomatic treatments)

Bushen Huoxue Simiao Formula group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the Western medicine diagnostic criteria: Patients who need lithotripsy surgery and have a double J stent (4.7F, 28 cm) placed after surgery; plain film of kidney and upper bladder indicates normal position of ureteral stent and no need for stage II surgery.
• Meet the Traditional Chinese Medicine (TCM) diagnostic criteria.
• Aged between 18 and 80 years old (inclusive).
• Voluntary participation with signed informed consent.

You may not qualify if:

• Patients with renal insufficiency stage 4 or 5, or acute renal failure.
• Secondary factors confirmed by examination, such as systemic lupus erythematosus or drug-induced kidney damage.
• Does not meet the diagnosis of upper urinary tract stones.
• Cases not within the scope of drug action.
• Long-term use of other relevant therapeutic drugs, or inability to stop medication immediately.
• Late-stage deformity, disability, or loss of labor ability.
• Complicated with severe primary diseases of heart, brain, liver, hematopoietic system, endocrine system, etc., or mental illness.
• Pregnant or lactating women.
• Patients in critical condition.
• Other conditions deemed unsuitable for enrollment by the researchers.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Conditions

Kidney Diseases; Nephrolithiasis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Hao Zhou

CONTACT

+8618959117277; haozhou@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, controlled trial evaluating the efficacy and safety of Shenkangling Compound (Yishen Huoxie Formula) in patients with Chronic Kidney Disease (CKD). Patients will be randomized to receive either Shenkangling plus standard care or standard care alone.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share