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

NCT04228757 | Unknown

• 1 other identifier: OBVIO-DSM-003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Nutritional Supplement

Outcome Measures

Primary Outcomes (1)

• Overall Menopausal Symptoms

  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.

  12 weeks

Secondary Outcomes (6)

• Overall Menopausal Symptoms

  8 weeks

• Incidence/severity of hot flash episodes

  12 weeks

• Feelings of fatigue

  12 weeks

• Health-related quality of life (EQ-VAS)

  12 weeks

• Vaginal dryness

  12 weeks

Other Outcomes (2)

• Blood biomarkers

  12 weeks

• Incidence of AEs

  12 weeks

Study Arms (2)

Investigational Herbal Blend

EXPERIMENTAL

A phytoestrogen herbal blend

Dietary Supplement: phytoestrogen herbal blend

Placebo

PLACEBO COMPARATOR

Tablet without active ingredients

Other: Placebo

Interventions

phytoestrogen herbal blend DIETARY_SUPPLEMENT

phytoestrogen herbal blend

Investigational Herbal Blend

Placebo OTHER

Tablet without active ingredients

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• i-Health, Inc.: lead
• ObvioHealth: collaborator

Study Sites (1)

ObvioHealth

Orlando, Florida, 32817, United States

Location

Related Publications (4)

• 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.

  PMID: 18580541 BACKGROUND

• 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.

  PMID: 19196674 BACKGROUND

• 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.

  PMID: 12117397 BACKGROUND

• 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.

  PMID: 24323914 BACKGROUND

Study Officials

• Parth Shah, MD

  ObvioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A unique ID number will be assigned by ClaimIt to each enrolled subject and associated with the correct study product kit number; this number will be used throughout the study. Both the study product and placebo will be labeled identically except for kit number and will be distinguishable only by the individual participant ID and kit number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled intervention

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 14, 2020
• Study Start: June 28, 2019
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)