TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management
Condition: Hot Flashes; Menopause
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests to see if TU 025 Keishi Bukuryo Gan reduces the frequency and severity of
      hot flashes in post-menopausal American women. This study will also estimate the best dose
      amount and determine the common short-term side effects and risks.
    

Detailed description: 
      Menopause is a natural transition in a woman's hormonal state associated with the cessation
      of ovulation and menstruation. For approximately 80% of peri-menopausal women, menopause may
      be defined by the experience of uncomfortable symptoms such as hot flashes, night sweats,
      dyspareunia, urinary frequency, sleep disturbance, fatigue, depression and anxiety.

      Hot flashes are the most common complaint of perimenopausal and postmenopausal Western women.
      Approximately 10-20% of postmenopausal women find such symptoms nearly intolerable. Nearly
      one-third of postmenopausal women experience disruptive hot flashes for 5 years after natural
      menopause and approximately 20% experience hot flashes for 15 years.

      Menopause has been understood as an estrogen deficiency state from which women are placed at
      great risk for osteoporosis, colon cancer and heart disease. For symptom management, as well
      as for disease prevention, the medical response for 20 years has been hormone replacement
      therapy (HRT). In recent years, as many as 38% of US women between ages 50 and 74 years were
      using HRT.

      For menopause hormone therapy, in 2005, counseling patients from an evidence-based
      perspective means informing patients of the significantly increased risk of dementia, breast
      cancer,endometrial cancer,venous thromboembolism and gallbladder disease. Additionally,
      physicians must also state that hormone therapy increases the risk of cardiovascular events
      (heart attack or strokes) in women with or without pre-existing heart disease. Furthermore,
      well-done studies demonstrate that hormone therapy does not enhance health-related quality of
      life.

      For this reason, there is great interest in non-hormonal alternatives for menopausal hot
      flash management. The current standard of care, based on controlled clinical trials in women
      with breast cancer, is the use of SSRI anti-depressants such as venlafaxine. However, many
      women seek other options.

      In Japan, TJ25 Keishi Bukuryo Gan is a leading non-hormonal prescription agent for management
      of menopausal hot flashes. However, no clinical data exists on its effectiveness in American
      women.

      This is a pilot phase II clinical study to estimate the effectiveness of TU-25 Keishi Bukuryo
      Gan for reduction of both the severity and the frequency of hot flashes in healthy
      postmenopausal American women. This study will also estimate the best dose and determine the
      common short-term side effects and risks.
    

Intervention name(s): TU 025 Keishi Bukuryo Gan
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hot flash; menopause; herbal medicine; kampo; alternative medicine