A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life

i-Health

Status

Unknown

Conditions

Menopause

Treatments

Dietary Supplement: phytoestrogen herbal blend

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04228757

OBVIO-DSM-003

Details and patient eligibility

About

This 12-week study is a randomized, placebo-controlled study assessing the efficacy of an herbal blend on menopausal symptoms and quality of life.

Full description

The purpose of this study is to evaluate changes in menopause symptoms after taking an herbal supplement daily for 12 weeks compared to placebo (a tablet that does not have active ingredients). This is a remote study, meaning all study data will be collected via the ClaimIt app, with the exception of a screening lab appointment and a Week 12 lab appointment.Participants will be asked to report on study compliance and respond to a series of questionnaires relating to symptoms of menopause, hot flashes, and quality of life.

Enrollment

130 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Females between 40 and 65 years of age
Report experiencing moderate to severe menopausal symptoms, characterized as including all of the following:
- Total Score of 11 or greater on the Greene Climacteric Scale (GCS) Questionnaire
- Self-reported frequent hot flashes experienced (estimated minimum of 28 during the past week, or an average of a minimum of 4 in a typical day)
- Absence of a regular menstrual cycle, defined as either: an irregular cycle for at least 6 months, or the absence of menses for 3 or more months
Agreement to maintain current level of physical activity throughout the study period
Willingness and ability to follow the procedures of the study
Willingness and ability to provide informed consent

Exclusion criteria

Participant with a Body Mass Index (BMI) ≥ 30mg/kg2
Participant who has had both ovaries removed
Women who are pregnant, breastfeeding, or planning on becoming pregnant during the course of the study
A history of breast cancer or a positive mammogram
A history of uterine cancer or an abnormal pap smear
Abnormal vaginal bleeding (not related to menstrual irregularity)
Liver disease
A history of clinically diagnosed depression that a medical professional recommended should be medically treated
A history of clinically diagnosed hypertension (systolic of 140 mmHg or greater or diastolic of 90 mmHg or greater)
Hyperthyroidism determined by thyroid stimulating hormone (TSH) screening
Any unstable medical condition as determined by the Principal Investigator (PI)
Any significant clinical or laboratory abnormality identified by the PI
Any change in the use of dietary supplements in the 2-month prior to enrollment
The use of any product indicated for menopause symptoms in the 2 months prior to enrollment including: prescription drugs (e.g. estrogen/progestins), over-the-counter supplements (e.g. black cohosh, soy isoflavones, evening primrose oil, phytoestrogens, etc), or a significant change in diet to include more soy foods.
The use of any psychiatric drugs in the 6 months prior to enrolling
Self-reported abuse of drugs or alcohol
Any smoking of cigarettes, vaping or e-cigarettes, or consumption of other tobacco products within the past 6 months
Planned donation of blood during or up to 30 days after completion of the study
An allergy to any ingredient in the herbal blend product or placebo
A sensitivity to botanical extracts
Previous participation in a clinical research study less than 30 days prior to randomization to a treatment group
Any other condition that in the investigator's opinion may adversely affect the participant's ability to complete the study, or may pose a significant risk to the participant