NCT03897738

Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B in women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms in perimenopause.

Detailed description

1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause. 2. To evaluate safety of combined use of dietary supplements Amberen and Smart B in women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause. 3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.

Conditions

• Perimenopause, Climacteric Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Amberen	Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
DIETARY_SUPPLEMENT	Smart B	Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
DIETARY_SUPPLEMENT	Placebo	Placebo capsules are identical to Amberen and Smart B capsules.

Timeline

• Start date: 2019-04-30
• Primary completion: 2020-02-18
• Completion: 2020-02-18
• First posted: 2019-04-01
• Last updated: 2020-02-20

Locations

1 site across 1 country: Russia