A Double blind, Randomized, Placebo Controlled Clinical Study of Efficacy and Safety of Baweidihuang-wan in Women Patients with Overactive Bladder

Clinical Study of Efficacy and Safety of Baweidihuang-wan in patients with Overactive Bladder

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000091

Enrollment

186

Registered

2011-01-27

Start date

2011-02-23

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : drug 1 ) Baweidihuang-wan 3g tid pc 8weeks - Rehmanniae radix 2g, Corni fructus 1g, Dioscoreae rhizoma 1g, Alismatis rhizoma 1g, Hoelen 1g, Moutan cortex 1g, Cinnamomi cortex 0.33g, Aconiti tub

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
average number of voiding for 1day;total number of urgency;Overactive Bladder Symptom Score(OABSS)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJang-Kung Park

Dongguk University

Outcome results