Overview
Black cohosh (Actaea racemosa or Cimicifuga racemosa), a member of the buttercup family, is a perennial plant which native to North America. Historical names for this plant include snakeroot, black bugbane, rattleweed, macrotys, and rheumatism weed. Black cohosh has a long history of use. Native Americans used it for its purported benefits in treating musculoskeletal pain, fever, cough, pneumonia, sluggish labor, and menstrual irregularities. European settlers were said to use black cohosh as a tonic to support female reproductive health. Hormone replacement therapy (HRT) is the standard treatment for early symptoms in post-menopausal women, however, increases the risk of stroke, heart diseases, as well as breast cancer in older women. Various studies have shown that the number of post-menopausal women using hormone replacement therapy is currently low and that the effects of hormone replacement therapy in reducing menopausal symptoms are not as positive as expected. For these reasons, there has been a trend toward using alternative therapies to relieve menopausal symptoms. Black cohosh has been associated with serious safety concerns. Results from studies suggest that C. racemosa possesses a central activity instead of a hormonal effect. The American College of Obstetrics and Gynecology guidelines on the use of botanicals, such as black cohosh, for the management of menopausal symptoms the use of for up to six months, especially in treating the symptoms of sleep and mood disturbance, and hot flushes.
Background
Black cohosh (Actaea racemosa or Cimicifuga racemosa), a member of the buttercup family, is a perennial plant which native to North America. Historical names for this plant include snakeroot, black bugbane, rattleweed, macrotys, and rheumatism weed. Black cohosh has a long history of use. Native Americans used it for its purported benefits in treating musculoskeletal pain, fever, cough, pneumonia, sluggish labor, and menstrual irregularities. European settlers were said to use black cohosh as a tonic to support female reproductive health. Hormone replacement therapy (HRT) is the standard treatment for early symptoms in post-menopausal women, however, increases the risk of stroke, heart diseases, as well as breast cancer in older women. Various studies have shown that the number of post-menopausal women using hormone replacement therapy is currently low and that the effects of hormone replacement therapy in reducing menopausal symptoms are not as positive as expected. For these reasons, there has been a trend toward using alternative therapies to relieve menopausal symptoms. Black cohosh has been associated with serious safety concerns. Results from studies suggest that C. racemosa possesses a central activity instead of a hormonal effect. The American College of Obstetrics and Gynecology guidelines on the use of botanicals, such as black cohosh, for the management of menopausal symptoms the use of for up to six months, especially in treating the symptoms of sleep and mood disturbance, and hot flushes.
Indication
Treatment of menopausal symptoms and menstrual dysfunction .
Associated Conditions
- Menopausal Symptoms
- Menopause Symptoms
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2016/11/02 | Phase 2 | Withdrawn | Midwestern Regional Medical Center | ||
2015/06/10 | Phase 4 | UNKNOWN | |||
2011/12/07 | Phase 3 | UNKNOWN | |||
2005/09/15 | Phase 4 | UNKNOWN | |||
2003/09/10 | Phase 1 | Terminated | |||
2003/08/05 | Phase 2 | Completed | |||
2001/02/05 | Phase 2 | Completed | |||
2001/02/05 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Apcco Labs, Inc | 82126-002 | VAGINAL | 2 [hp_X] in 1 mg | 6/18/2025 | |
King Bio Inc. | 57955-2822 | ORAL | 10 [hp_X] in 59 mL | 5/20/2025 | |
Bestmade Natural Products | 82969-5041 | ORAL | 30 [hp_C] in 30 [hp_C] | 5/27/2025 | |
King Bio Inc. | 57955-5276 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 | |
King Bio Inc. | 57955-9150 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 | |
King Bio Inc. | 57955-6163 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Lifetime Menopause Revival Premium Gold | 297837 | Medicine | A | 12/20/2017 | |
Women's PMS Relieve Tablets | 488730 | Medicine | A | 5/14/2025 | |
SUMMIT GUAIACUM COMPLEX oral liquid bottle | 45830 | H.E Kugelman & Co | Medicine | A | 7/21/1993 |
Hilde Hemmes' Herbals Swedish Bitters Capsules | 82846 | Medicine | A | 5/21/2002 |