The Clinical Research of Traditional Chinese Medicine Formula

A Clinical Study on Bushen Huoxue Simiao Formula for Nourishing the Kidneys and Promoting Blood Circulation to Improve Postoperative Complications of Upper Urinary Tract Stones

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Disease; Urologic Injuries
• Intervention / Treatment: Drug: Bushen Huoxue Simiao Formula; Other: control group

Detailed Description

1. Study Design and Methods 1.1 Research Method A multicenter, open-label study design was used. 1.2 Source of Participants The cases in this clinical observation were recruited from the Department of Urology at the Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu Traditional Chinese Medicine Hospital, and Fujian Provincial People's Hospital. All patients were diagnosed with upper urinary tract stones (including kidney stones and ureteral stones) and underwent ureteroscopic holmium laser lithotripsy and stone removal. A 4.7F, 28 cm double-J stent was left in place postoperatively, and patients returned to the hospital 4 weeks later for stent removal. Participants were randomly assigned to either the "Four-Ingredient Formula for Nourishing the Kidneys and Promoting Blood Circulation" group or the control group using a random number table. Informed consent was obtained from all enrolled participants.

1.3 Participant Selection and Exclusion Criteria 1.3.1 Western Medicine Diagnostic Criteria According to the definitions of renal stones and ureteral stones in *Practical Urology*, a diagnosis of renal stones or ureteral stones is made based on the presence or absence of stone-related symptoms and signs, in conjunction with the patient's medical history and the results of a urinary tract color Doppler ultrasound and non-contrast abdominal CT scan performed after admission.

1.3.2 Traditional Chinese Medicine Diagnostic Criteria

Based on clinical manifestations, in accordance with the *Guidelines for Clinical Research on New Traditional Chinese Medicines* and the *General Principles for Clinical Research on New Traditional Chinese Medicines*-both formulated in accordance with the National Standards of the People's Republic of China-and with reference to the views of various scholars, the following criteria have been established:

Kidney Deficiency with Blood Stasis and Damp-Heat Syndrome Principal Symptoms: Distending, aching, stabbing, or localized pain in the lower back and abdomen, occurring intermittently and worsening with exertion; may be accompanied by hematuria, vomiting, or painful and difficult urination; or may be asymptomatic.

Secondary Symptoms: Dry mouth and throat or a dark red throat; rough skin or numbness in the limbs; a red or predominantly red tongue, or a dark purple tongue with ecchymoses or petechiae; and a fine, thin pulse.

At least one of the primary symptoms and at least two of the secondary symptoms must be present, and the tongue and pulse findings must be consistent.

1.3.3 Inclusion Criteria

1. Meets Western medical diagnostic criteria, requires surgical removal of stones, and has a 4.7F, 28 cm double-J stent placed postoperatively; plain radiographs of the kidneys and upper bladder indicate that the ureteral stent is properly positioned and no secondary surgery is required;
2. Meets the Traditional Chinese Medicine syndrome differentiation criteria;
3. Age 18 ≤ age ≤ 80;
4. Voluntarily participate and sign an informed consent form. 1.3.4 Exclusion Criteria

(1) Patients with Stage 4 or 5 renal insufficiency or acute renal failure; (2) Patients with conditions confirmed by examination to be caused by secondary factors such as systemic lupus erythematosus or drug-induced kidney damage; (3) Patients who do not meet the diagnostic criteria for upper urinary tract stones; (4) Cases not within the scope of the drug's indications; (5) Patients who are taking other relevant medications long-term or who cannot discontinue such medications immediately; (6) Patients with advanced deformities, disabilities, or loss of working capacity; (7) Patients with severe primary diseases of the heart, brain, liver, hematopoietic system, endocrine system, or other systems, as well as patients with psychiatric disorders; (8) Pregnant or breastfeeding women; (9) Patients in critical condition; (10) Other circumstances deemed unsuitable for inclusion in the study. 1.3.5 Participant Withdrawal 1.3.5.1 Investigator-Determined Withdrawal

1. The investigator determines that it is necessary to stop the study from an ethical perspective;
2. Serious adverse events occur, and the participant should no longer continue the trial;
3. Serious co-morbidities arise during treatment;
4. The investigator determines that withdrawal from the study is in the participant's best interest;
5. Other reasons. 1.3.5.2 Participant-Determined Withdrawal Participants have the right to withdraw from the trial at any stage, or if the participant does not withdraw informed consent but fails to continue medication or follow-up, they are considered lost to follow-up.

1.3.6 Dropout Criteria

1. Serious adverse events or complications occur;
2. The participant requests to withdraw from the trial during the study;
3. Unable to contact the participant during the trial. 1.3.7 Exclusion Criteria

(1) Found to not meet inclusion criteria after enrollment; (2) Poor compliance with the study protocol, including not following prescribed medication or clinical tests; (3) Incomplete data during the trial, making it impossible to evaluate the drug's efficacy and safety.

2.4 Treatment Plan and Grouping 2.4.1 Trial Medication Bushen Huoxue Simiao formula Composition: Prepared Rehmannia Root, Psoralea, Cornus Officinalis, Dodder Seed, Eucommia Bark, Angelica Root, Goji Berries, Cistanche, Myrrh, Du Huo, Safflower, Atractylodes, Phellodendron Bark, Achyranthes Root, Coix Seed, etc.

Formulation: Decoction Dosage: 150 ml per dose Source: Zhejiang Sanxi Tang Chinese Medicine Co., Ltd. 2.4.2 Grouping This study involves two groups: In accordance with the principles of randomized controlled trials, patients were divided into a control group and an experimental group, each consisting of 40 patients. The control group received standard treatment (postoperative anti-infective therapy, fluid replacement, hemostasis, antispasmodic and analgesic therapy, and other symptomatic treatments), while the experimental group received, in addition to standard treatment, an oral decoction of the "Bushen Huoxue Simiao formula" (one dose per day, taken twice-once 30 minutes before breakfast and once 30 minutes after dinner).

Randomization Method: Random numbers (1-80) are generated using SPSS software and randomly assigned to the Bushen Huoxue Simiao formula group and the control group, each receiving 40 numbers. The distribution results are kept confidential by the group leader, who determines and records the grouping and sequence number of patients.

2.5 Statistical Analysis Method SPSS v22.0 will be used for statistical analysis. Categorical data will be analyzed using the χ² test. Continuous data will be presented as means ± standard deviations (SD) and compared using t-tests. Statistical significance is set at p < 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hao Zhou; Phone Number: +8618959117277; Email: haozhou@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Meet the Traditional Chinese Medicine (TCM) diagnostic criteria.
3. Aged between 18 and 80 years old (inclusive).
4. Voluntary participation with signed informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; 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; 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.
Experimental: Bushen Huoxue Simiao Formula group; Bushen Huoxue Simiao Formula	Other: control group; The control group received standard treatment (postoperative anti-infective therapy, fluid replacement, hemostasis, antispasmodic and analgesic therapy, and other symptomatic treatments)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Abnormal Urinalysis Results	Percentage of participants (%). The proportion of participants presenting with abnormal urinalysis findings (including specific gravity, pH, WBC, RBC, or protein) compared to baseline.	Baseline and 4 weeks after treatment
Serum Creatinine (SCr) Level	Unit: mg/dL (or μmol/L). Measurement of renal function via serum creatinine levels.	Baseline and 4 weeks after treatment
Blood Urea Nitrogen (BUN) Level	Unit: mg/dL (or mmol/L). Measurement of renal function via blood urea nitrogen levels.	Baseline and 4 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine (TCM) Syndrome Score	Evaluation of TCM syndrome scores based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition). Scoring Method: Main symptoms are scored from 0 to 6, and secondary symptoms are scored from 0 to 3. Score Range: The total score ranges from 0 to 30.Interpretation: Higher scores indicate more severe TCM syndromes. A decrease in score indicates improvement.	Time Frame: Baseline, Week 4, Week 8, and Week 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Renal Stone; Renal Fibrosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis; Kidney Diseases; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: KY-2025-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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