NCT03118908

Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: Female
• Age: 42 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions; 2. To evaluate safety of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause, lasting no less than 1 year in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions; 3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause (menopausal for at least 1 year).

Conditions

• Climacteric Syndrome
• Menopause

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: 2017-04-24
• Primary completion: 2017-10-10
• Completion: 2017-10-10
• First posted: 2017-04-18
• Last updated: 2017-10-20

Locations

1 site across 1 country: Russia