Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328348
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-18
Brief Title:
Assessing the Synergistic Effects of Black Cohosh Soy Isoflavones and SDG Lignans Soloways TM on Menopausal Symptoms
Sponsor:
SLAB SOLOWAYS
Organization:
SLAB SOLOWAYS
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studys 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 studys design also included measures to ensure adherence and minimize bias such as drug container returns and daily reminders The involvement of SLab 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
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 studys design also included measures to ensure adherence and minimize bias such as drug container returns and daily reminders The involvement of SLab 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None