Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118908
Other study ID # AmberenSmartB-2017
Secondary ID
Status Completed
Phase N/A
First received April 13, 2017
Last updated October 18, 2017
Start date April 24, 2017
Est. completion date October 10, 2017

Study information

Verified date July 2017
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date October 10, 2017
Est. primary completion date October 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 42 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
Russian Federation Sechenov First Moscow Medical University Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spilberger-Hanin (Situational anxiety) The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale week 12
Primary Spilberger-Hanin (Personal anxiety) The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale week 12
Primary 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
Primary WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being) Statistically significant reduction in designated symptom severity, compared between arms week 12
Primary WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity) Statistically significant reduction in designated symptom severity, compared between arms week 12
Primary WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood) Statistically significant reduction in designated symptom severity, compared between arms week 12
Primary Anxiety (measured by Hospital Anxiety and Depression Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Primary Depression (measured by Hospital Anxiety and Depression Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Feeling tense or nervous" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Difficulty in sleeping" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Excitable" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Attacks of panic" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Difficulty in concentrating" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Loss of interest in most things" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Feeling unhappy or depressed" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Crying spells" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Irritability" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Feeling dizzy or faint" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Headaches" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Muscle or joint pains" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary Breathing difficulties" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Hot flushes" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Sweating at night" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary "Loss of interest in sex" symptom (Greene Climacteric Scale) Statistically significant reduction in designated symptom severity, compared between arms week 12
Secondary Blood plasma estradiol levels, pg/ml Statistically significant reduction in the levels, compared between arms week 12
Secondary Weight, kg Statistically significant reduction in the measurement, compared between arms week 12
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A