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Completed

NCT Number: NCT06328348

Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms

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.

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Key information

Conditions

Menopause Symptoms

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Supplementation

Dietary Supplement

group receiving a course of Black Cohosh, Soy Isoflavones, and SDG Lignans

Placebo

Other

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Follicle-Stimulating Hormone (FSH) change

    Time frame: 90 days

  2. Estradiol change

    Time frame: 90 days

  3. Number of any adverse events

    Time frame: 90 days

    any reported adverse events

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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