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

Not Applicable

• Conditions: Menopause
• Interventions: Dietary Supplement: phytoestrogen herbal blend; Other: Placebo

• Registration Number: NCT04228757
• Lead Sponsor: i-Health, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-06-28
• Study First Submitted: 2019-12-20
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-04-04
• Study Completion: 2020-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Herbal Blend	phytoestrogen herbal blend	A phytoestrogen herbal blend
Placebo	Placebo	Tablet without active ingredients

Primary Outcome Measures

Name	Time	Method
Overall Menopausal Symptoms	12 weeks	Change from baseline in global menopausal symptoms assessed by the Greene Climacteric Questionnaire at Week 12.; The Greene Climacteric Questionnaire is a 21-item validated questionnaire that provides a measurement of global menopause symptoms, grouping questions into psychological, physical, vasomotor, and sexual domains. Participants answer on a 4-point scale. Each response is given a numerical value from 0 to 3 points respectively, and the sum total of their 21-point responses is calculated as their GCS score.

Secondary Outcome Measures

Name	Time	Method
Overall Menopausal Symptoms	8 weeks	Change from baseline in global menopausal symptoms assessed by Greene Climacteric questionnaire at weeks 2, 4 and 8.; The Greene Climacteric Questionnaire is a 21-item validated questionnaire that provides a measurement of global menopause symptoms, grouping questions into psychological, physical, vasomotor, and sexual domains. Participants answer on a 4-point scale. Each response is given a numerical value from 0 to 3 points respectively, and the sum total of their 21-point responses is calculated as their GCS score.
Incidence/severity of hot flash episodes	12 weeks	Change from baseline in frequency of hot flash episodes as measured by self-report of incidence of hot flashes at week 2, 4, 8, and 12, considering: * Total number of episodes; * Number of episodes per category of intensity: mild, moderate, severe and very severe
Feelings of fatigue	12 weeks	Change from baseline in feelings of fatigue as measured by Chalder Fatigue Scale questionnaire scores at weeks 4, 8, and 12.; The CFS is an 11-point questionnaire that provides a numerical value for overall symptoms of fatigue. Participants are asked to answer about their experience of fatigue related symptoms on a 4-point scale including "Less than usual", "No more than usual", "More than usual" and "Much more than usual" on the first 10 questions. On the final question the options are "Better than usual", "No worse than usual", "Worse than usual" and "Much worse than usual". Each score is given a numerical score of 0-3 respectively, and a total calculated as the sum of the 11 responses.
Vaginal dryness	12 weeks	Change from baseline in self-reported vaginal dryness on a five-point scale as measured by response to a study-specific questionnaire item at weeks 2, 4, 8, and 12
Health-related quality of life (EQ-VAS)	12 weeks	Change from baseline in health-related quality of life as measured by the EuroQol visual analogue scale (EQ-VAS) at weeks 2, 4, 8, and 12.; The EQ-VAS is a questionnaire that requires participants to report self-perception of how good their health is that day on a 100-point visual analogue scale.
Perception of wellness	12 weeks	Participant perception of wellness after 12 weeks of supplementation, as documented by listed responses to open-ended questions in a study-specific questionnaire.

Trial Locations

Locations (1)

ObvioHealth; 🇺🇸 Orlando, Florida, United States