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

Menopause Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06328348
• Other study ID #: SW010
• Status: Completed
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Symptoms

Intervention

Dietary Supplement:
• supplementation
group receiving a course of Black Cohosh, Soy Isoflavones, and SDG Lignans

Other:
• placebo
placebo

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days
Secondary	Follicle-Stimulating Hormone (FSH) change		90 days
Secondary	Estradiol change		90 days
Secondary	Number of any adverse events	any reported adverse events	90 days