Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome
NCT ID: NCT03118908
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2017-04-24
2017-10-10
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Amberen and Smart B
Amberen - a dietary supplement: 2 capsules (one while capsule 200 mg and one orange capsule 200 mg) are taken once a day with a meal, preferably after breakfast, for 3 months.
SMART В - a dietary supplement: 1 capsule per day (166 mg) is taken once a day with a meal, preferably after breakfast, for 3 months, concurrently with Amberen.
Amberen
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
Smart B
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
Placebo
Placebo is taken as follows: 3 capsules (one while capsule 200 mg, one orange capsule 200 mg, one capsule 166mg) are taken once a day with a meal, preferably after breakfast, for 3 months.
Placebo
Placebo capsules are identical to Amberen and Smart B capsules.
Interventions
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Amberen
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
Smart B
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
Placebo
Placebo capsules are identical to Amberen and Smart B capsules.
Eligibility Criteria
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Inclusion Criteria
* Patient with diagnosis of "climacteric syndrome", in typical or non-complicated form, mild or moderate vegetative symptoms during menopause i.e. absence of menstrual period for at least 1 year;
* Ability to read and understand informed consent form for the study's participation;
* Patients without risk factors and changes in the breast tissue based on the mammogram;
* Patients with medical history of risk factors without changes in the breast tissue;
* Ability to adhere to the conditions of the study.
Exclusion Criteria
* Presence of extragenital oncological conditions, except those in complete remission for 5 years or more;
* Conditions requiring emergency or planned hospitalization in the next 6 months;
* Presence of hormonally-active extragenital endocrine diseases (thyroid, adrenal, pituitary, hypothalamus);
* Surgical interventions done on sex organs or breasts, 1 year or less prior to the screening;
* Any surgeries done less than 3 months prior to the screening;
* Patients receiving HRT;
* Psychiatric conditions;
* Diabetes;
* Total ovariectomy
* Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the study
* High risk of non-compliance
42 Years
60 Years
FEMALE
Yes
Sponsors
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I.M. Sechenov First Moscow State Medical University
OTHER
Responsible Party
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Kuznetsova Irina
Chief Researcher, Scientific Research Centre, Women's Health Scientific Research Department, I.M. Sechenov First Moscow State Medical University, University hospital #2, Obstetrics and Gynecology clinic.
Locations
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Sechenov First Moscow Medical University
Moscow, , Russia
Countries
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Other Identifiers
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AmberenSmartB-2017
Identifier Type: -
Identifier Source: org_study_id