Skip to content

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome : a pilot trial

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome : a randomized, double-blind, placebo-controlled pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002040
Enrollment
50
Registered
2016-09-05
Start date
2016-10-26
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

None listed

Interventions

Drug : Experimental group: Guizhifulingwan(cinnamomi ramulus, poria, moutan cortex, persicae semen, paeoniae radix) 3 grams per time orally 3 times per day for 4 weeks. Control group: placebo 3 grams

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

MeasureTime frame
Menopause rating scale

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJeong-Eun Yoo

Dunsan Korean Medicine Hospital of Daejeon University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 10, 2026