View clinical trials related to Climacteric Symptoms.
Filter by:The purpose of this study is to investigate the positive effects of red ginseng extract on intestinal bacterial changes and immunity, free radicals, antioxidant capacity, and autonomic nervous system changes in age of 40~75 men and women with climacteric symptoms for 24 weeks.
The current study will evaluate systematically the efficacy and cost-effectiveness of two internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the severity of menopausal symptoms and improving copings skills with regard to hot flushes and night sweats as well as improving sexual functioning, improving quality of sleep, reducing emotional distress and improving quality of life in younger breast cancer patients who experience treatment-induced menopause.
This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women
Postmenopausal women with a history of breast cancer often suffer from climacteric symptoms such as hot flushes and sweating episodes. Conventional hormone therapy is not allowed in such patients because there are indications that hormones may cause breast cancer to recur. Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical profile that is different from conventional hormones. In contrast to conventional hormones, tibolone does not increase breast density and causes less breast pain. The LIBERATE study is a study in which the safety and efficacy of tibolone has been investigated in postmenopausal women that have been treated for breast cancer.
Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a paucity of data supporting their efficacy and safety. Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush. Design and Setting:A multi-center, prospective, observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals. Participants:In total, 136 eligible subjects entered this study. They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations. Main Outcome Measures:During the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (AEs) occurring to them by using Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug. Every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of tolerability. During the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.