The Clinical Research of Traditional Chinese Medicine Formula
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bushen Huoxue Simiao Formula
DrugPatients 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
Other interventionThe control group received standard treatment (postoperative anti-infective therapy, fluid replacement, hemostasis, antispasmodic and analgesic therapy, and other symptomatic treatments)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: control groupOther 1 intervention
Group B: Bushen Huoxue Simiao Formula groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 4 weeks after treatmentSecondary outcomes
1
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.
Time frame
Baseline and 4 weeks after treatment2
Serum Creatinine (SCr) Level
Unit: mg/dL (or μmol/L). Measurement of renal function via serum creatinine levels.
Time frame
Baseline and 4 weeks after treatment3
Blood Urea Nitrogen (BUN) Level
Unit: mg/dL (or mmol/L). Measurement of renal function via blood urea nitrogen levels.
Time frame
Baseline and 4 weeks after treatmentOther outcomes
1
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
Time Frame: Baseline, Week 4, Week 8, and Week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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