MenopauseNCT04228757
A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
A study testing phytoestrogen herbal blend in people with Menopause, run by i-Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- phytoestrogen herbal blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 4 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This 12-week study is a randomized, placebo-controlled study assessing the efficacy of an herbal blend on menopausal symptoms and quality of life.
Read the 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.
- Conditions
- Menopause
- Being tested
- phytoestrogen herbal blend, Placebo
- Keywords
- Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytoestrogen herbal blendDietary supplement
phytoestrogen herbal blend
PlaceboOther
Tablet without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Investigational Herbal Blend | Experimental | A phytoestrogen herbal blend Receives: Dietary Supplement: phytoestrogen herbal blend |
| Placebo | Placebo comparator | Tablet without active ingredients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Overall Menopausal Symptoms
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.
Measured: 8 weeks
Incidence/severity of hot flash episodes
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
Measured: 12 weeks
Feelings of fatigue
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.
Measured: 12 weeks
Health-related quality of life (EQ-VAS)
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.
Measured: 12 weeks
Vaginal dryness
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
Measured: 12 weeks
Perception of wellness
Participant perception of wellness after 12 weeks of supplementation, as documented by listed responses to open-ended questions in a study-specific questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start28 Jun 2019
- Primary completion4 Apr 2020 (estimated)
- Study completion4 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled intervention
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Parth Shah, MD, Principal investigator, ObvioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228757
- Sponsor's protocol ID
- OBVIO-DSM-003
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18580541Chlebowski 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.
PubMed 19196674Rossouw 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.
PubMed 12117397Lethaby 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.
PubMed 24323914
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life
- ClinicalTrials.gov ID
- NCT04228757
- Acronym / sponsor ID
- OBVIO-DSM-003
- Conditions
- Menopause
- Keywords
- Nutritional Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- i-Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 4 Apr 2020 (estimated)
- Study completion
- 4 Apr 2020 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Investigational Herbal Blend | Experimental | Dietary Supplement: phytoestrogen herbal blendA phytoestrogen herbal blend |
| Placebo | Placebo comparator | Other: PlaceboTablet without active ingredients |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females between 40 and 65 years of age
- Report experiencing moderate to severe menopausal symptoms, characterized as including all of the following:
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phytoestrogen herbal blendphytoestrogen herbal blend | Dietary supplement | Investigational Herbal Blend |
| PlaceboTablet without active ingredients | Other | Placebo |
Primary outcome
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.
6 secondary outcomes
Overall Menopausal Symptoms
Time frame: 8 weeks
Incidence/severity of hot flash episodes
Time frame: 12 weeks
Feelings of fatigue
Time frame: 12 weeks
Health-related quality of life (EQ-VAS)
Time frame: 12 weeks
Vaginal dryness
Time frame: 12 weeks
Perception of wellness
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 18580541Utian 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.
- Background: PubMed 19196674Chlebowski 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.
- Background: PubMed 12117397Rossouw 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.
- Background: PubMed 24323914Lethaby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parth Shah, MD principal investigator
ObvioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phytoestrogen herbal blend in people with Menopause, run by i-Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Menopausal Symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228757, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.