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

S.LAB (SOLOWAYS)

Status

Completed

Conditions

Menopause Symptoms

Treatments

Other: placebo

Dietary Supplement: supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT06328348

SW010

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

Female

Ages

45 to 60 years old

Volunteers

No Healthy Volunteers

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