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

NCT00119418 ↗

Phase 2 Completed 180 enrolled Plotnikoff, Gregory A., M.D. Tsumura and Company, Tokyo, Japan · collab University of Minnesota · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-11
Primary completion: —
Completion: 2006-02

Outcome

Missed primary endpoint

paper However, the differences in changes between groups were not statistically significant (P = 0.990). PMID 21738077 ↗

paper TU-025 did not significantly reduce the frequency and severity of hot flash symptoms PMID 21738077 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TU 025 Keishi Bukuryo Gan	Traditional medicine (herbal / TCM)	7.5 g	—
Subject	TU 025 Keishi Bukuryo Gan	Traditional medicine (herbal / TCM)	12.5 g	—

Indications

No indication recorded.