A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Menopause
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blind, placebo-controlled interventionMasking: 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
Participation Requirements
- Age
- Between 40 years and 65 years
- Gender
- Only males
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 o...
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.
Tracking Information
- NCT #
- NCT04228757
- Collaborators
- ObvioHealth
- Investigators
- Principal Investigator: Parth Shah, MD ObvioHealth