A Phase 2 interventional study of Black Cohosh and Placebo in Hot Flashes, sponsored by Midwestern Regional Medical Center. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Midwestern Regional Medical Center · Phase 2, Interventional, and Treatment
This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
Browse Hot Flashes studies →Midwestern Regional Medical Center is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Black Cohosh will be provided in 250mg capsules. Subjects will take 2 capsules by mouth daily for a total daily dose of 500 mg. Subject's will remain on this study arm for 8 weeks.
Drug: Black Cohosh
Subjects will take 2 capsules, identical to the Black Cohosh capsules, by mouth each. Subject's will remain on this study arm for 8 weeks.
Other: Placebo
Vital Nutrients Black Cohosh Extract
Also known as: Actaea racemosa
Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.
Frequency of hot flashes as calculated from self reported questionnaire
Subjects will record the number and timing of their on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each week during the study.
Time frame: Daily assessments throughout the study (assessed for up to 16 weeks)
Severity of hot flashes as calculated from self reported questionnaire
Subjects will record the intensity of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Time frame: Daily assessments throughout the study (assessed for up to 16 weeks)
Quality of life as recorded from self reported questionnaire
Subjects will answer questions regarding the impact of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Time frame: Daily assessments throughout the study (assessed for for up to 16 weeks)
Measurement of serum testosterone
The effect of Black Cohosh on serum testosterone will be measured at the end of each 8-week treatment cycle.
Time frame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
Measurement of serum aspartate aminotransferase (AST)
The effect of Black Cohosh on AST will be measured at the end of each 8-week treatment cycle.
Time frame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
Measurement of serum alanine aminotransferase (ALT)
The effect of Black Cohosh on serum ALT will be measured at the end of each 8-week treatment cycle.
Time frame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
Measurement of serum bilirubin
The effect of Black Cohosh on serum bilirubin will be measured at the end of each 8-week treatment cycle.
Time frame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
Measurement of serum Prostate Specific Antigen (PSA)
The effect of Black Cohosh on serum PSA will be measured at the end of each 8-week treatment cycle.
Time frame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Midwestern Regional Medical Center