갈근강황추출물의 갱년기 증상 개선에 대한 유효성 및 안전성 평가
Efficacy and Safety of Extract Obtained from Pueraria thunbergiana Bentham and Curcuma longa L. on the Improvement of the Menopausal Symptoms
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Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.
Abstract
Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.
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