A Double blind, Randomized, Placebo Controlled Clinical Study of Efficacy and Safety of Baweidihuang-wan in Women Patients with Overactive Bladder
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000091
- Lead Sponsor
- Dongguk University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 186
1) female aged more than 40
2) symptoms of urinary urgency and frequency more than 3months.
3) korea OABSS >3 at first visit
4) after first visit, URS=2 and urination number per day >8 and/or urge incontinence
5) agreed the study
1) diagnosed UTI in U/A
2) stress incontinence without symptoms of OAB
3) suspicious neurologic bladder
4) history of cystocele, hysterocele
5) history of obstrcutive uropathy ; urolithiasis, tumor, etc
6) history of bladder surgery
7) history of urinary malignant tumor
8) history of neuropsychiatric disease (schizophrenia, drug addiction, epilepsy, etc)
9) The other condition, which makes the patient unsuitable for inclusion in the opinion of investigator
(uncontrolled HTN, DM, thyroid disease, acute, chronic hepatitis/cirrhosis, severe hyperlipidemia, severe heart disease, Tbc, ather infectional disease)
10) hypersensitivity, allergy og the study related drug
11) OMD diagnose '????' ; dehydration oral cavitiy, redness of tongue, face, eyes, sweating at night, etc
12) parcipication in other clinical trial within 3months
13) use of drugs within 1months preceding bladder function
(Tolterodine, Trospium, Solifenacin, Propantheline, Atropine, Hyoscyamine, Fesoterodine fumarate, Oxybutynin, Propiverine, Imipramine, Alfuzosin, Doxazocin, Prazosin,Terazosin, Tamsulosin, etc)
14) unsuitable condition which intake herb medication because of systemic disease
15) person who did not writing
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method average number of voiding for 1day;total number of urgency;Overactive Bladder Symptom Score(OABSS)
- Secondary Outcome Measures
Name Time Method King's Health Questionnaire(KHQ);Patient Perception of Bladder Condition(PPBC);Female Sexual Function Index(FSFI);automatic nerve condition, blood vessel aging in use of SA-6000;adverse events