Climacteric SyndromeNCT03118908
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome
A study testing Amberen and Smart B in people with Climacteric Syndrome and Menopause, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 42 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Climacteric Syndrome, Menopause
- What is being tested?
- Amberen and Smart B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteRussia
- Study dates
- 24 Apr 2017to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B by Women With Climacteric Syndrome
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.
Read the detailed description
- 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;
- 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;
- 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
- Being tested
- Amberen, Smart B, Placebo
- Keywords
- Succinate, B complex vitamins, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmberenDietary supplement
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
Smart BDietary supplement
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
PlaceboDietary supplement
Placebo capsules are identical to Amberen and Smart B capsules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spilberger-Hanin (Situational anxiety)
The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale
Measured: week 12
Spilberger-Hanin (Personal anxiety)
The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale
Measured: 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.
Measured: week 12
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
Anxiety (measured by Hospital Anxiety and Depression Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
Depression (measured by Hospital Anxiety and Depression Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
Secondary outcomes (23)
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Feeling tense or nervous" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Difficulty in sleeping" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Excitable" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Attacks of panic" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Difficulty in concentrating" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Loss of interest in most things" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Crying spells" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Irritability" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Headaches" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Muscle or joint pains" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
Breathing difficulties" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Hot flushes" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Sweating at night" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
"Loss of interest in sex" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: week 12
Blood plasma estradiol levels, pg/ml
Statistically significant reduction in the levels, compared between arms
Measured: week 12
Weight, kg
Statistically significant reduction in the measurement, compared between arms
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start24 Apr 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118908
- Sponsor's protocol ID
- AmberenSmartB-2017
- Status last verified
- Jul 2017
- First submitted
- 13 Apr 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B by Women With Climacteric Syndrome
- ClinicalTrials.gov ID
- NCT03118908
- Acronym / sponsor ID
- AmberenSmartB-2017
- Conditions
- Climacteric Syndrome, Menopause
- Keywords
- Succinate, B complex vitamins, menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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;
- 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;
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amberen and Smart B | Experimental | Dietary Supplement: Amberen, Dietary Supplement: Smart BAmberen - 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 42 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmberenAmberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms. | Dietary supplement | Amberen and Smart B |
| Smart BSmart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate. | Dietary supplement | Amberen and Smart B |
| PlaceboPlacebo capsules are identical to Amberen and Smart B capsules. | Dietary supplement | Placebo |
Primary outcome
Spilberger-Hanin (Situational anxiety)
Time frame: week 12
The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale
Spilberger-Hanin (Personal anxiety)
Time frame: week 12
The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale
Spilberger-Hanin (Actual anxiety)
Time frame: week 12
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.
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)
Time frame: week 12
Statistically significant reduction in designated symptom severity, compared between arms
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity)
Time frame: week 12
Statistically significant reduction in designated symptom severity, compared between arms
WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)
Time frame: week 12
Statistically significant reduction in designated symptom severity, compared between arms
Anxiety (measured by Hospital Anxiety and Depression Scale)
Time frame: week 12
Statistically significant reduction in designated symptom severity, compared between arms
Depression (measured by Hospital Anxiety and Depression Scale)
Time frame: week 12
Statistically significant reduction in designated symptom severity, compared between arms
23 secondary outcomes
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
Time frame: week 12
"Feeling tense or nervous" symptom (Greene Climacteric Scale)
Time frame: week 12
"Difficulty in sleeping" symptom (Greene Climacteric Scale)
Time frame: week 12
"Excitable" symptom (Greene Climacteric Scale)
Time frame: week 12
"Attacks of panic" symptom (Greene Climacteric Scale)
Time frame: week 12
"Difficulty in concentrating" symptom (Greene Climacteric Scale)
Time frame: week 12
"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
Time frame: week 12
"Loss of interest in most things" symptom (Greene Climacteric Scale)
Time frame: week 12
"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
Time frame: week 12
"Crying spells" symptom (Greene Climacteric Scale)
Time frame: week 12
"Irritability" symptom (Greene Climacteric Scale)
Time frame: week 12
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)
Time frame: week 12
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
Time frame: week 12
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
Time frame: week 12
"Headaches" symptom (Greene Climacteric Scale)
Time frame: week 12
"Muscle or joint pains" symptom (Greene Climacteric Scale)
Time frame: week 12
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
Time frame: week 12
Breathing difficulties" symptom (Greene Climacteric Scale)
Time frame: week 12
"Hot flushes" symptom (Greene Climacteric Scale)
Time frame: week 12
"Sweating at night" symptom (Greene Climacteric Scale)
Time frame: week 12
"Loss of interest in sex" symptom (Greene Climacteric Scale)
Time frame: week 12
Blood plasma estradiol levels, pg/ml
Time frame: week 12
Weight, kg
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amberen and Smart B in people with Climacteric Syndrome and Menopause, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spilberger-Hanin (Situational anxiety) (time frame: week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.