TU 025 Keishi Bukuryo Gan for Post-menopausal Hot Flash Management

NCT00119418 | Completed Phase 2

• 3 other identifiers: 0402M56292M01-RR00400 NIHM01RR000400
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hot Flashes; Menopause

Keywords

hot flash; menopause; herbal medicine; kampo; alternative medicine

Outcome Measures

Primary Outcomes (1)

• frequency and severity of hot flashes by Mayo Hot Flash Diary

Secondary Outcomes (6)

• sleep quality by the Pittsburgh Questionnaire

• bodyweight/BMI by standard measurements

• quality of menopausal life by Greene Climacteric Scale

• lipid profile by laboratory test

• liver function profile by laboratory test

Interventions

TU 025 Keishi Bukuryo Gan DRUG

Eligibility Criteria

• Age: 45 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Post-menopausal women aged 45-58 with an adequate hot flash frequency severity score. Post-menopause is defined as amenorrhea for at least 12 months, or post-hysterectomy for more than one year with follicle-stimulating hormone levels greater than or equal to 40 mIU/mL and estradiol (E2) levels of less than or equal to 20 pg/mL, or greater than two months post oophorectomy.
• All subjects must be up to date with both pap and mammogram screening by the US Preventative Services Taskforce Guidelines for the length of the trial.
• All subjects on any prescription medication need the approval of their prescribing physician for participation in the trial.

You may not qualify if:

• Concurrent hot flash therapies (prescription medications including hormones, antidepressants, SERMs, gabapentin or over the counter supplements)
• Moderately severe disease state(s) or diseases that affect absorption/metabolism, or diseases that mimic menopausal hot flashes.
• Inability to swallow vitamin size pills
• Beck depression inventory score greater than 11
• Greater than 10 cigarettes per day
• Abnormal liver function
• Treated or untreated hypertension greater than 160/90.
• BMI greater than 36
• Inability to give consent or commit to the length of the trial
• Known hypersensitivity to ingredients
• Physician judgment

Sponsors & Collaborators

• Plotnikoff, Gregory A., M.D.: lead
• Tsumura and Company, Tokyo, Japan: collaborator
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota General Clinical Research Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Plotnikoff GA, Watanabe K, Torkelson C, La Valleur J, Radosevich DM. The TU-025 keishibukuryogan clinical trial for hot flash management in postmenopausal women: results and lessons for future research. Menopause. 2011 Aug;18(8):886-92. doi: 10.1097/gme.0b013e31821643d9.

  PMID: 21738077 DERIVED

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: July 4, 2005
• First Posted: July 13, 2005
• Study Start: November 1, 2004
• Study Completion: February 1, 2006
• Last Updated: October 26, 2010

Record last verified: 2005-07

Locations

US (1)