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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Menopause

In brief

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

Key facts

Study ID

NCT04228757

Run by

i-Health, Inc.

People needed

130

Starts

2019-06-28

Expected to finish

2020-04-04

Last updated by the study team

2020-02-05

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ObvioHealth — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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