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A clinical study on the efficacy and toxicity of Radix Puerariae in the treatment of bladder overactivity with M3 receptor inhibitors

A clinical study on the efficacy and toxicity of Radix Puerariae in the treatment of bladder overactivity with M3 receptor inhibitors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119121
Enrollment
Unknown
Registered
2026-02-23
Start date
2024-07-29
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Over active bladder

Interventions

Solifenacin:Solifenacin
Solifenacin and kudzu vine root(8g):Solifenacin and kudzu vine root(8g)
Solifenacin and kudzu vine root(4g):Solifenacin and kudzu vine root(4g)

Sponsors

Beijing Bo'ai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 18 to 75 years old, regardless of gender; 2.Voluntary signing of informed consent form; 3.OAB patients who exhibit symptoms such as frequent urination, urgency, nocturia, or urgent urinary incontinence without obvious causes; 4.Urinary frequency, urgency, and nocturia caused by neurological diseases; 5.The urination diary shows patients with an average of >= 8 urinations per 24 hours;

Exclusion criteria

Exclusion criteria: 1. Autonomous urination patients with difficulty urinating; 2.(2) Patients who require indwelling catheterization to empty the bladder; 3.(3) Individuals who are allergic to the research drug or have an allergic constitution; 4.(4) Pregnant, breastfeeding, renal dysfunction (>1.5 times normal), liver function>2 times normal (5) patients with an average 24-hour urine output>200 ml per session or an average 24-hour urination frequency<8 times; 5.(6) Bladder outlet obstruction; 6.(7) Individuals with obvious stress urinary incontinence; 7.(8) Complex or severe urinary tract infections; 8.(9) Individuals who have a preference and a preference for Chinese and Western medicine treatment.

Design outcomes

Primary

MeasureTime frame
The number of times the average frequency of urination/catheterization per 24 hours decreased compared to the baseline after 8 weeks of oral treatment;

Secondary

MeasureTime frame
Quality of Life Index Score ( QOL);24-hour average urine leakage volume;Wenex Constipation Scoring Sheet;The average number of times of urination/catheterization per 24 hours in the 4th week after administration decreased compared with the baseline;Average volume of urine per urination/catheterization volume;The average number and score of urgent urination within 24 hours;OABSS score;The average number of urinary incontinence cases within 24 hours;

Countries

China

Contacts

Public ContactLu shousi

Beijing Bo'ai Hospital

luss12@163.com+86 10 8702 0529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026