Oral Product for Menopausal Symptoms Relief
This study of Mellow Menopause, an oral product, aims to support menopausal women by evaluating its effect on hot flashes over 24 hours compared to a placebo.
Placebo
+ Dietary Supplement with actives
Supportive Care Study
Summary
Study start date: July 7, 2025
Actual date on which the first participant was enrolled.This study is focused on exploring the benefits of an oral product designed for individuals experiencing menopausal symptoms, particularly vasomotor symptoms like hot flashes. The study targets those undergoing menopause who often face discomfort due to these symptoms. Understanding how an oral dietary supplement can alleviate such symptoms could lead to improved quality of life for many people experiencing menopause, addressing a significant need for non-hormonal treatment options. Participants in this study will take part in a randomized, double-blind, placebo-controlled trial, meaning neither the participants nor the researchers will know who is receiving the actual supplement and who is receiving a placebo. Each participant will keep a daily diary to log their symptoms and experiences, and they will complete validated questionnaires, such as the Greene Climacteric Scale (GCS), to assess changes in their symptoms over time. This approach will help determine the effectiveness of the oral product in managing menopausal symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Healthy Females aged 40 to 65 years * Self-reporting menopausal symptoms (\> 5 hot flashes per day) and have been present for a minimum of previous 60 days prior to baseline visit * Reporting a variable cycle length of \> 7 days different from normal * NORMAL BMI (per metropolitan life tables): under 30 kg/m2 * Able to read, understand, and complete the study questionnaire and records. * Able to understand the study procedures. * Able to comply with all study requirements. * Written informed consent to participate in the study. * Willingness to actively participate in the study and to come to the scheduled visits. Exclusion Criteria: * Pregnancy or breastfeeding. * Immune insufficiency * Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal. * History of hysterectomy * Women on hormone replacement therapy * Use of systemic corticosteroids or immunosuppressant drugs. * Other diseases or medications that might directly interfere in the study or put the panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.) * Cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol * Alcohol or drug abuse * Use of hormonal contraceptives within the last 3 months * Use of other menopause supplements or drugs * Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest) * Oophorectomy or amenorrhea \> two years. * Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period * Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month * Employees of the institute or the brand owner or the manufacturers of the product * Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
San Francisco Research Institute
San Francisco, United StatesOpen San Francisco Research Institute in Google Maps