Clinical trial NCT04228757: A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
Official title: A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: Nutritional Supplement
Lead sponsor: i-Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2020-01-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Menopausal Symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Menopausal Symptoms
timeFrame: 8 weeks
measure: Incidence/severity of hot flash episodes
timeFrame: 12 weeks
measure: Feelings of fatigue
timeFrame: 12 weeks
measure: Health-related quality of life (EQ-VAS)
timeFrame: 12 weeks
measure: Vaginal dryness
timeFrame: 12 weeks
measure: Perception of wellness
timeFrame: 12 weeks
Other outcomes:
measure: Blood biomarkers
timeFrame: 12 weeks
measure: Incidence of AEs
timeFrame: 12 weeks
Locations:
city: Orlando
country: United States
facility: ObvioHealth
state: Florida
Study officials:
affiliation: ObvioHealth
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Utian WH, Archer DF, Bachmann GA, Gallagher C, Grodstein Fn, Heiman JR, Henderson VW, Hodis HN, Karas RH, Lobo RA, Manson JE, Reid RL, Schmidt PJ, Stuenkel CA; North American Menopause Society. Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause. 2008 Jul-Aug;15(4 Pt 1):584-602. doi: 10.1097/gme.0b013e31817b076a.
citation: Chlebowski RT, Kuller LH, Prentice RL, Stefanick ML, Manson JE, Gass M, Aragaki AK, Ockene JK, Lane DS, Sarto GE, Rajkovic A, Schenken R, Hendrix SL, Ravdin PM, Rohan TE, Yasmeen S, Anderson G; WHI Investigators. Breast cancer after use of estrogen plus progestin in postmenopausal women. N Engl J Med. 2009 Feb 5;360(6):573-87. doi: 10.1056/NEJMoa0807684.
citation: Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
citation: Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev. 2013 Dec 10;2013(12):CD001395. doi: 10.1002/14651858.CD001395.pub4.