Menopause SymptomsNCT06328348
Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms
A study testing supplementation in people with Menopause Symptoms, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause Symptoms
- What is being tested?
- supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteRussia
- Study dates
- 18 Jul 2023to 30 Dec 2023
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Time since menopause less than 10 years
- Natural menopause confirmed
- Abstainers from smoking and alcohol consumption
- Normal thyroid function tests and lipid profiles
- Body Mass Index (BMI) within the 18.5-30 kg/m2 range, to ensure a representative sample of the population
- Recent mammography and gynecological examination (within the last year) confirming the absence of breast or reproductive system diseases
Who cannot join
- Contraindications to hormone therapy, including a history of suspected or diagnosed malignancy
- Use of hormonal treatments or products derived from soybeans or cod liver oil within the last 12 months
- Allergies to soybeans or cod liver oil
- Engagement in professional athletic activities
- Current use of medications that may interact with study supplements, including but not limited to sulfonamides, methotrexate, triamterene, sulfasalazine, phenytoin, anxiolytics, antidepressants, as well as daily chemicals, multivitamins, aspirin, or painkillers
- Use of alternative herbal remedies for vasomotor symptoms within the past month
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- Participation in another investigational program involving interventions outside of routine clinical practice within the last 6 months
- Presence of uncontrolled hypertension or diabetes, or a significant psychiatric condition that could interfere with study participation
- History of serious cardiovascular diseases, including myocardial infarction or stroke
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.
The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.
The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power.
- Conditions
- Menopause Symptoms
- Being tested
- supplementation, placebo
- Keywords
- Postmenopausal women, Menopause Rating Scale, supplementation, lignans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementationDietary supplement
group receiving a course of Black Cohosh, Soy Isoflavones, and SDG Lignans
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| supplementation group | Experimental | Not described Receives: Dietary Supplement: supplementation |
| placebo group | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Menopause Rating Scale (MRS) score
Each symptom is rated on a scale from 0 (no complaints) to 4 (severe symptoms), leading to a total MRS score that ranges from 0 to 44
Measured: 90 days
Secondary outcomes (3)
Follicle-Stimulating Hormone (FSH) change
Measured: 90 days
Estradiol change
Measured: 90 days
Number of any adverse events
any reported adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start18 Jul 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopause SymptomsStudies 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, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328348
- Sponsor's protocol ID
- SW010
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pokushalov E, Ponomarenko A, Garcia C, Kasimova L, Pak I, Shrainer E, Romanova A, Kudlay D, Johnson M, Miller R. Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial. Eur J Nutr. 2025 Mar 25;64(3):138. doi: 10.1007/s00394-025-03588-y.
PubMed 40131516
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06328348
- Acronym / sponsor ID
- SW010
- Conditions
- Menopause Symptoms
- Keywords
- Postmenopausal women, Menopause Rating Scale, supplementation, lignans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Mar 2024 (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.
This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.
The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.
The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplementation group | Experimental | Dietary Supplement: supplementation |
| placebo group | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Time since menopause less than 10 years
- Natural menopause confirmed
- Abstainers from smoking and alcohol consumption
- Normal thyroid function tests and lipid profiles
- Body Mass Index (BMI) within the 18.5-30 kg/m2 range, to ensure a representative sample of the population
Key exclusion criteria (9 listed)
- Contraindications to hormone therapy, including a history of suspected or diagnosed malignancy
- Use of hormonal treatments or products derived from soybeans or cod liver oil within the last 12 months
- Allergies to soybeans or cod liver oil
- Engagement in professional athletic activities
- Current use of medications that may interact with study supplements, including but not limited to sulfonamides, methotrexate, triamterene, sulfasalazine, phenytoin, anxiolytics, antidepressants, as well as daily chemicals, multivitamins, aspirin, or painkillers
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 |
|---|---|---|
| supplementationgroup receiving a course of Black Cohosh, Soy Isoflavones, and SDG Lignans | Dietary supplement | supplementation group |
| placeboplacebo | Other | placebo group |
Primary outcome
Change in the Menopause Rating Scale (MRS) score
Time frame: 90 days
Each symptom is rated on a scale from 0 (no complaints) to 4 (severe symptoms), leading to a total MRS score that ranges from 0 to 44
3 secondary outcomes
Follicle-Stimulating Hormone (FSH) change
Time frame: 90 days
Estradiol change
Time frame: 90 days
Number of any adverse events
Time frame: 90 days
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 25 Mar 2024.
- Derived from this study: PubMed 40131516Pokushalov E, Ponomarenko A, Garcia C, Kasimova L, Pak I, Shrainer E, Romanova A, Kudlay D, Johnson M, Miller R. Assessing the combined effects of Black Cohosh, Soy Isoflavones, and SDG Lignans on menopausal symptoms: a randomized, double-blind, placebo-controlled clinical trial. Eur J Nutr. 2025 Mar 25;64(3):138. doi: 10.1007/s00394-025-03588-y.
- Individual participant dataSharing planned: Undecided
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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 supplementation in people with Menopause Symptoms, run by S.LAB (SOLOWAYS) 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 9 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 25 Mar 2024. 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?
Change in the Menopause Rating Scale (MRS) score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06328348, which also lists 1 linked publication.
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 25 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.