A clinical trial of Desmodium styracifolium total flavone capsule in the treatment of ureteral calculi

Desmodium styracifolium total flavone capsule in the treatment of ureteral calculi: A phase III randomized, double blind, parallel controlled clinical trial of efficacy and safety

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013275

Enrollment

Unknown

Registered

2017-11-07

Start date

2017-11-01

Completion date

Unknown

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ureteral calculi

Interventions

Desmodium styracifolium total flavone capsule:Desmodium styracifolium total flavone capsule

placebo:placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) diagnosed as ureteral calculi disease; (2) Male and female aged 18 to 70 years old; (3) Traditional Chinese Medicine diagnosed as Damp-heat accumulation; (4) calculi position below the first narrow part of ureter (stricture of uretero-pelvic junction), calculi diameter: 0.5cm to l.0cm; (5) Good renal function, especially the affected side renal function; moderate or mild hydronephrosis; (6) Good general condition, life self-care; (7) Signed informed consent form. The informed consent process complies with GCP.

Exclusion criteria

Exclusion criteria: (1) bladder calculi, urethral calculi, kidney calculi; (2) uretero-pelvic junction or distal ureter with malformations, stenosis, obstruction and operation scar adhesion; (3) severe hydronephrosis (grade III), Renal cysts, alanine aminotransferase (ALT) or aspartate aminotransferase (AST): 1.5 times higher than the upper limit of normal; urea nitrogen or creatinine: 1.2 times higher than the normal; (4) sustained severe hematuria, or shock; (5) acute obstructive oliguria, anuria; (6) Pregnancy, nursing woman, positive HCG test; (7) cardiovascular, hepatic, renal, hematopoietic system of primary severe disease, or poor controlled diabetes and hypertension, or to affect the survival of the serious diseases (such as cancer or AIDS), or mental or legally disabled patients; (8) within one week, use drugs treating urolithiasis; (9) have the risk of loss to fellow-up, such as work change frequently; (10) within three months, participated in other clinical trials; (11) known or suspected allergy.

Design outcomes

Primary

Measure	Time frame
D28 urinary calculus expulsion rate;	—

Secondary

Measure	Time frame
D14 urinary calculus expulsion rate;urinary calculus expulsion time;improvement of traditional Chinese medicine symptom score;urinary calculus decline situation;	—

Countries

China

Contacts

Public ContactHe Zhenyu

Wuhan Guanggu Humanwell Bio-pharma CO. LTD

hezhenyu@renfu.com.cn+86 13627255229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 11, 2026