MenopausePhase 3BCOMSNCT02093650
Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms
A Phase 3 study testing black cohosh extract in people with Menopause and Quality of Life, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Quality of Life
- What is being tested?
- black cohosh extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2014to Jul 2016
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at least 40 years
- Peri or post menopause
- Moderate to severe menopausal symptoms (Kupperman index at least 20)
Who cannot join
- Use hormonal treatment or other treatments within 4 weeks
- Use atorvastatin azathioprine or cyclosporin within 4 weeks
- BMI at least 30 kg m2
- Allergic to drug or components
- Liver disease or abnormal liver function test
- Psychiatric disease
- Alcoholic or drug abuse
- Vegetarian
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Dusit, Bangkok, 10300
Patsama Vichinsartvichai, MD, +66877905656, pat_si109@hotmail.com
Patsama Vichinsartvichai, MD
About this study
Official title: Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial
Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms
Read the detailed description
Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL
- Conditions
- Menopause, Quality of Life
- Being tested
- black cohosh extract, Placebo
- Keywords
- Menopausal symptoms, menopause related quality of life, black cohosh, cimicifuga racemosa, MENQOL, Kupperman index, KI, liver function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
black cohosh extractDrug
Also called Femosa
Black cohosh extract 80 mg
PlaceboDrug
Soy bean oil
| Study group | Role | What they receive |
|---|---|---|
| Black cohosh extract | Active comparator | black cohosh extract 80 mg daily Receives: Drug: black cohosh extract |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in Kupperman Index
Kupperman index questionnaire at baseline, 4, 8 and 12 weeks
Measured: baseline, week 4, week 8 and week 12
Secondary outcomes (5)
A change in MENQOL
MENQOL questionnaire measurement at baseline and 12 weeks
Measured: baseline and week 12
The changes in daily hot flushes frequency
Daily hot flushes frequency over 12 weeks treatment
Measured: baseline, week 4, week 8 and week 12
Global satisfaction
Overall patient satisfaction 0 - 10 scale
Measured: week 12
A change in liver function test
Changes in liver function test from baseline and 12 weeks
Measured: baseline and week 12
adverse events
frequency of adverse events
Measured: week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patsama Vichinsartvichai, Navamindradhiraj University
- Investigators
- Patsama Vichinsartvichai, MD, Principal investigator, Faculty of Medicine Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093650
- Sponsor's protocol ID
- 081/56
- Other IDs
- TCTR20140318001
- Acronym
- BCOMS
- Status last verified
- Sep 2014
- First submitted
- 19 Mar 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02093650
- Acronym / sponsor ID
- BCOMS / 081/56
- Conditions
- Menopause, Quality of Life
- Keywords
- Menopausal symptoms, menopause related quality of life, black cohosh, cimicifuga racemosa, MENQOL, Kupperman index, KI, liver function tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Mar 2014 (estimated)
- 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.
Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms
Detailed description
Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black cohosh extract | Active comparator | Drug: black cohosh extractblack cohosh extract 80 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 40 years
- Peri or post menopause
- Moderate to severe menopausal symptoms (Kupperman index at least 20)
Key exclusion criteria (8 listed)
- Use hormonal treatment or other treatments within 4 weeks
- Use atorvastatin azathioprine or cyclosporin within 4 weeks
- BMI at least 30 kg m2
- Allergic to drug or components
- Liver disease or abnormal liver function test
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 |
|---|---|---|
| black cohosh extractAlso: FemosaBlack cohosh extract 80 mg | Drug | Black cohosh extract |
| PlaceboSoy bean oil | Drug | Placebo |
Primary outcome
The changes in Kupperman Index
Time frame: baseline, week 4, week 8 and week 12
Kupperman index questionnaire at baseline, 4, 8 and 12 weeks
5 secondary outcomes
A change in MENQOL
Time frame: baseline and week 12
The changes in daily hot flushes frequency
Time frame: baseline, week 4, week 8 and week 12
Global satisfaction
Time frame: week 12
A change in liver function test
Time frame: baseline and week 12
adverse events
Time frame: week 4, week 8 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Patsama Vichinsartvichai, MD principal investigator
Faculty of Medicine Vajira Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing black cohosh extract in people with Menopause and Quality of Life, run by Navamindradhiraj University at 1 site in Thailand.
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 3 inclusion and 8 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 25 Sep 2014. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Patsama Vichinsartvichai, MD. (+66877905656, pat_si109@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in Kupperman Index (time frame: baseline, week 4, week 8 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2014.