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

NCT03118908 | Completed

• 1 other identifier: AmberenSmartB-2017
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Climacteric Syndrome; Menopause

Keywords

Succinate; B complex vitamins; menopause

Outcome Measures

Primary Outcomes (8)

• Spilberger-Hanin (Situational anxiety)

  The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale

  week 12

• Spilberger-Hanin (Personal anxiety)

  The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

  week 12

• Spilberger-Hanin (Actual anxiety)

  The decrease of actual anxiety, measured as statistically significant reduction of the score in corresponding subscale. Actual anxiety as a sum of situational and personal anxiety scores was introduced by Hanin in his modification of original State-Trait Anxiety Inventory.

  week 12

• WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)

  Statistically significant reduction in designated symptom severity, compared between arms

  week 12

• WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity)

  Statistically significant reduction in designated symptom severity, compared between arms

  week 12

• WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)

  Statistically significant reduction in designated symptom severity, compared between arms

  week 12

• Anxiety (measured by Hospital Anxiety and Depression Scale)

  Statistically significant reduction in designated symptom severity, compared between arms

  week 12

• Depression (measured by Hospital Anxiety and Depression Scale)

  Statistically significant reduction in designated symptom severity, compared between arms

  week 12

Secondary Outcomes (23)

• "Heart beating quickly and strongly" symptom (Greene Climacteric Scale)

  week 12

• "Feeling tense or nervous" symptom (Greene Climacteric Scale)

  week 12

• "Difficulty in sleeping" symptom (Greene Climacteric Scale)

  week 12

• "Excitable" symptom (Greene Climacteric Scale)

  week 12

• "Attacks of panic" symptom (Greene Climacteric Scale)

  week 12

Study Arms (2)

Amberen and Smart B

EXPERIMENTAL

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.

Dietary Supplement: Amberen; Dietary Supplement: Smart B

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Amberen DIETARY_SUPPLEMENT

Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.

Amberen and Smart B

Smart B DIETARY_SUPPLEMENT

Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.

Amberen and Smart B

Placebo DIETARY_SUPPLEMENT

Placebo capsules are identical to Amberen and Smart B capsules.

Placebo

Eligibility Criteria

• Age: 42 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients, 42-60 years of age;
• 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.

You may not qualify if:

• Presence of female reproductive system cancers (breast cancer, cervical cancer etc.);
• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov First Moscow Medical University

Moscow, 119991, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: April 24, 2017
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)