Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome : a pilot trial
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0002040
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
(1) Those aged between 45 and 60
(2) Climacteric (before and after menopause) women (including both natural menopause and induced menopause)
(3) Those whose menopause rating scale score is 9 points or higher
(4) Those whose physical strength is moderate or higher
(5) Those whose upward movement of qi is moderate or higher
(6) Those whose lower abdominal resistance and tenderness is moderate or higher
(7) Those who sufficiently listened about this clinical trial and consented to participate in this study and signed an agreement for participants
(1) Those with a seriously unstable medical condition
(2) Those with a severe mental disease
(3) Those whose aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), and ?-glutamyltranspeptidase(?-GTP) levels are 1.5 times as high as or higher than the normal upper limit
(4) Those whose blood urea nitrogen and creatinine levels are 1.5 times as high as or higher than the normal upper limit
(5) Those whose thyroid stimulating hormone level is 1.5 times lower than the normal lower limit
(6) Those whose body mass index is lower than 18.5
(7) Those whose hemoglobin level is lower than 11 g/dI
(8) Those who received estrogen therapy within one year
(9) Those who received herbal medicine therapy related to climacteric syndrome within four weeks
(10) Those who experienced vaginal bleeding without a cause after menopause
(11) Those who have lactose intolerance
(12) Those who are participating in other clinical research
(13) Those who are in collective dwelling facilities such as social welfare institutions
(14) Those who do not agreed to the written consent
(15) Other cases considered inappropriate for the clinical trial by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Menopause rating scale
- Secondary Outcome Measures
Name Time Method World Health Organization quality of life-BREF(WHOQOL-BREF);Degree of upward movement of qi, degree of lower abdominal resistance·tenderness;Questionnaire for blood stasis pattern;Lipid test;High sensitivity c-reactive protein(hs-CRP);Follicle stimulating hormone(FSH), estradiol(E2);Recruitment rate, completion rate, medication adherence