Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B in Women With Climacteric Syndrome in Perimenopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- "Panic attacks" symptom (Greene Climacteric Scale)
研究概览
简要总结
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.
详细描述
- To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects, 50 years of age or younger;
- •Subjects in the second phase of menopausal transition as per STRAW 10+ i.e. interval of amenorrhea 60 days or more (with regular menstrual cycle during earlier reproductive stages).
- •Subjects with diagnosis of mild to moderate climacteric syndrome;
- •Recent (up to 12 months prior to study enrollment) breast exam results, including mammogram, that rule out malignancies;
- •Recent (up to 3 years prior to study enrollment) cytological screening that rules out vaginal cervix malignancies.
- •Ability to read and understand informed consent form for the study's participation;
- •Ability to adhere to the conditions of the study.
排除标准
- •• Postmenopause, including surgical menopause.
- •Presence of hormone-dependent cancers;
- •Presence of other cancers, not in full remission with no recurrence for 5 years or more;
- •Planned hospitalization in the next 6 months;
- •Presence of hormonally-active extragenital endocrine diseases (diabetes; diseases of thyroid, adrenal, pituitary) that require prolonged or life-long therapies
- •Surgical interventions on sex organs or breasts, 1 year or less prior to the screening;
- •Gynecological conditions that may require hormonal therapies or surgeries (uterine myoma, endometriosis, endometrial hyperplasia etc.);
- •Currently undergoing or planning to utilize assisted reproductive technologies;
- •Any abdominal surgeries within less than 3 months prior to the screening;
- •HRT including MHRT or hormonal contraceptives - current or within less than 3 months prior to the screening;
- •Psychiatric conditions;
- •Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the trial;
- •High risk of non-compliance.
结局指标
主要结局
"Panic attacks" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 5 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Crying spells" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 10 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Irritability" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 11 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Breathing difficulties" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 18 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Loss of interest in sex" symptom (Greene Climacteric Scale)
时间窗: 90 and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 21 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 12 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Muscle or joint pains" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 16 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Increased Excitability" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 4 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Difficulty concentrating" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 6 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 14 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Headaches" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 15 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Difficulty sleeping" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 3 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Loss of interest in most things" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 8 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Feeling of sadness or depression" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 9 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 17 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 1 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Feeling tense or nervous" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 2 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Feeling tired or lacking energy" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 7 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 13 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
"Night sweats" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 20 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
Blood plasma estradiol levels, pg/ml
时间窗: 90 and 180 days
Statistically significant changes in the levels, compared between arms
"Hot flushes" symptom (Greene Climacteric Scale)
时间窗: 90 days and 180 days
Statistically significant change in designated symptom severity, compared between arms. This is question 19 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"
次要结局
- State-Trait Anxiety Inventory (State anxiety sub-scale)(90 and 180 days)
- State-Trait Anxiety Inventory (Trait anxiety sub-scale)(90 and 180 days)
- Depression sub-score (measured by Hospital Anxiety and Depression Scale)(90 and 180 days)
- Well-being sub-score (Russian well-being, activity and mood questionnaire)(90 and 180 days)
- State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales )(90 and 180 days)
- Mood sub-score (Russian well-being, activity and mood questionnaire)(90 and 180 days)
- Anxiety sub-score (measured by Hospital Anxiety and Depression Scale)(90 and 180 days)
- Activity sub-score (Russian well-being, activity and mood questionnaire)(90 and 180 days)
研究者
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.
I.M. Sechenov First Moscow State Medical University