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

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ClinicalTrials.gov Identifier: NCT04228757
Recruitment Status : Active, not recruiting
First Posted : January 14, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
ObvioHealth
Information provided by (Responsible Party):
i-Health, Inc.

Tracking Information
First Submitted Date  ICMJE December 20, 2019
First Posted Date  ICMJE January 14, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE June 28, 2019
Estimated Primary Completion Date April 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Overall Menopausal Symptoms [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
Overall Menopausal Symptoms [ Time Frame: 12 weeks ]
Global menopausal symptoms assessed by Greene Climacteric Questionnaire application) symptoms over 12 weeks of consumption
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Overall Menopausal Symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Health-related quality of life (EQ-VAS) [ Time Frame: 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.
  • Vaginal dryness [ Time Frame: 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
  • Perception of wellness [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Hot Flashes [ Time Frame: 12 weeks ]
    incidence and severity of hot flash episodes as measured by the Hot Flash Weighted Index
  • Health-related quality of life [ Time Frame: 12 weeks ]
    Health-related quality of life as determined by the VQ-VAS
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2020)
  • Blood biomarkers [ Time Frame: 12 weeks ]
    Chemistry Panel including liver enzymes and CBC
  • Incidence of AEs [ Time Frame: 12 weeks ]
    Incidence of Adverse Events (AEs) observed during the treatment period, classified by the investigator as to intensity, relationship to study product/protocol, and seriousness
Original Other Pre-specified Outcome Measures
 (submitted: January 10, 2020)
Blood biomarkers [ Time Frame: 12 weeks ]
Chemistry Panel including liver enzymes and CBC
 
Descriptive Information
Brief Title  ICMJE A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
Official Title  ICMJE A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled intervention
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE
  • Dietary Supplement: phytoestrogen herbal blend
    phytoestrogen herbal blend
  • Other: Placebo
    Tablet without active ingredients
Study Arms  ICMJE
  • Experimental: Investigational Herbal Blend
    A phytoestrogen herbal blend
    Intervention: Dietary Supplement: phytoestrogen herbal blend
  • Placebo Comparator: Placebo
    Tablet without active ingredients
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 4, 2020
Estimated Primary Completion Date April 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04228757
Other Study ID Numbers  ICMJE OBVIO-DSM-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party i-Health, Inc.
Study Sponsor  ICMJE i-Health, Inc.
Collaborators  ICMJE ObvioHealth
Investigators  ICMJE
Principal Investigator: Parth Shah, MD ObvioHealth
PRS Account i-Health, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP