Hot FlashesPhase 3NCT01487694
Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women
A Phase 3 study testing cimicifuga racemosa in people with Hot Flashes, run by Mahidol University at 1 site in Thailand.
Trial summary
Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with 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
- Hot Flashes
- What is being tested?
- cimicifuga racemosa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2011to Oct 2012
- 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
- Thai women, aged ≥ 40 years
- Peri- or postmenopause
- Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
Who cannot join
- Using any drugs or hormonal treatment within 1 month before enrollment
- BMI ≥ 30 kg/m2
- Allergic to drugs or any ingredient
- Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
- Psychiatric disease
- Alcohol consumption or any elicit drug use
- Vegetarian (may consume more phytoestrogen)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Prasong Tanmahasamut, MD
Patsama Vichinsartvichai, MD
About this study
Official title: Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial
Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.
- Conditions
- Hot Flashes
- Being tested
- cimicifuga racemosa, placebo
- Keywords
- back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cimicifuga racemosaDrug
Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)
placeboDrug
matching placebo without active ingredient 1 tab daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cimicifuga racemosa | Experimental | patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg) Receives: Drug: cimicifuga racemosa |
| Placebo | Placebo comparator | Placebo containing no active ingredient which match the drug in bottle, shape, color and smell Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean differences of Kupperman index
Measured: 12 weeks
Secondary outcomes (6)
Frequencies of menopausal symptoms
Measured: 12 weeks
Compliance
Measured: 12 weeks
adverse events
Measured: 12 weeks
Mean differences of liver function test
Measured: 12 weeks
quality of life
Thai MENQOL measurement
Measured: 12 weeks
Overall satisfaction
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 posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patsama Vichinsartvichai, MD, Principal investigator, Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487694
- Sponsor's protocol ID
- Si573/2011
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01487694
- Acronym / sponsor ID
- Si573/2011
- Conditions
- Hot Flashes
- Keywords
- back cohosh, cimicifuga racemosa, menopausal symptoms, hot flashes, Kupperman index, MENQOL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Dec 2011 (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.
Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.
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 |
|---|---|---|
| Cimicifuga racemosa | Experimental | Drug: cimicifuga racemosapatients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg) |
| Placebo | Placebo comparator | Drug: placeboPlacebo containing no active ingredient which match the drug in bottle, shape, color and smell |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thai women, aged ≥ 40 years
- Peri- or postmenopause
- Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
Key exclusion criteria (7 listed)
- Using any drugs or hormonal treatment within 1 month before enrollment
- BMI ≥ 30 kg/m2
- Allergic to drugs or any ingredient
- Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
- Psychiatric disease
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 |
|---|---|---|
| cimicifuga racemosaCimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg) | Drug | Cimicifuga racemosa |
| placebomatching placebo without active ingredient 1 tab daily for 12 weeks | Drug | Placebo |
Primary outcome
Mean differences of Kupperman index
Time frame: 12 weeks
6 secondary outcomes
Frequencies of menopausal symptoms
Time frame: 12 weeks
Compliance
Time frame: 12 weeks
adverse events
Time frame: 12 weeks
Mean differences of liver function test
Time frame: 12 weeks
quality of life
Time frame: 12 weeks
Overall satisfaction
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 29 Dec 2011.
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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
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
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 cimicifuga racemosa in people with Hot Flashes, run by Mahidol 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 7 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 29 Dec 2011. 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 (664194657-8, pat_si109@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean differences of Kupperman index (time frame: 12 weeks). 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 29 Dec 2011.