Randomized controlled trial on the efficacy and safety of Wenglitong capsules against overactive bladder

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-14005626
• Date of registration: 2014-12-07
• Prospective Registration: No
• Primary sponsor: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine
• Public title: Randomized controlled trial on the efficacy and safety of Wenglitong capsules against overactive bladder
• Scientific title: Randomized controlled trial on the efficacy and safety of Wenglitong capsules against overactive bladde
• Date of first enrolment: 2014-01-01
• Target sample size: A:30;B:30;C:30;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10019
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: III (Phase III study)

Countries of recruitment

China

Contacts

• Name: Dongdong Xiao
• Affiliation: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine

• Name: Mujun Lu

Key inclusion & exclusion criteria

Inclusion criteria: 1) female, age ranging from 18 to 75;
2) diagnosed as OAB at out-patient departments;
3) urinary frequency and urinary urgency, with or without urgency urinary incontinence;
4) urine volume per micturition < 200ml;
5) diagnosed as traditional Chinese medicine syndrome of dampness heat and blood stasis (represent yellow and slimy tongue fur);
6) urine routine test excluded urinary tract infection and represented no sign of urinary tract infection 4 weeks before screening;
7) patients were able to complete micturition diary with good compliance.
Exclusion criteria: 1) with severe cardiac diseases and arrhythmia;
2) with severe hepatic and renal diseases, in which case aspartate aminotransferase, alanine aminotransferase and creatinine are 1.5 times greater than the upper limit of normal reference range;
3) with contraindication of anticholinergic therapy, such as urinary retention, gastric retention, uncontrolled angle-closure glaucoma and allergy to Wenglitong capsules;
4) acute urinary tract infection with symptoms during screening period;
5) hematuria with unknown cause, cancer, interstitial cystitis, neurogenic bladder, bladder outlet obstruction, urethral catheterization, brain trauma, thyroid diseases, diabetes mellitus and other diseases which researchers recognized as unsuitable to be included in this trial;
6) pregnancy, lactation or prepared to pregnancy.

Age minimum: 18
Age maximum: 75
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

A:Wegnlitong Capsules;B:Extended-release Tolterodine;C:Wegnlitong Capsules & Extended-release Tolterodine;

Primary Outcome(s)

Overactive bladder symptom score;Micturition diary;

Secondary Outcome(s)

Type-B ultrasonic checks;

Source(s) of Monetary Support

the General Programs of the National Natural Science Foundation of China (No. 81070605 & No. 81370860) and the Biomedical Engineering Research Fund of Shanghai Jiao Tong University (No. YG2011MS14).