AtherosclerosisPhase 3PEARS-POSTNCT01742000
Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
A Phase 3 study testing Karinat in people with Atherosclerosis, run by Institute for Atherosclerosis Research, Russia.
Trial summary
The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Karinat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at least 5 years after menopause
- Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
- The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
- The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
- The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion
Who cannot join
- Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion
- Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
- Personal history or diagnostic of following diseases:
- Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
- Pulmonary thromboembolism
- Chronic heart failure IIa-III
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- Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy)
- Malignancy
- Chronic renal failure II-III
- Chronic hepatic failure II-III
- Liver cirrhosis
- Individual intolerance of Karinat or major side effects
About this study
Official title: Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.
- Conditions
- Atherosclerosis
- Being tested
- Karinat, Placebo
- Keywords
- postmenopause, phytoestrogen, atherosclerosis, intima-media thickness
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarinatDietary supplement
PlaceboDrug
Sugar pill manufactured to mimic Karinat 500 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Karinat | Active comparator | Karinat 500 mg tablet by mouth three times a day Receives: Dietary Supplement: Karinat |
| Sugar pill | Placebo comparator | Placebo 500 mg tablet by mouth three times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Measured: up to 2 years
Secondary outcomes (1)
Measure of serum atherogenicity
Change of the ability of serum to induce cholesterol accumulation in cultured cells
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2007
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742000
- Sponsor's protocol ID
- IAR-KT-POST
- Acronym
- PEARS-POST
- Status last verified
- Sep 2012
- First submitted
- 2 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01742000
- Acronym / sponsor ID
- PEARS-POST / IAR-KT-POST
- Conditions
- Atherosclerosis
- Keywords
- postmenopause, phytoestrogen, atherosclerosis, intima-media thickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Dec 2012 (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.
The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karinat | Active comparator | Dietary Supplement: KarinatKarinat 500 mg tablet by mouth three times a day |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo 500 mg tablet by mouth three times a day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women at least 5 years after menopause
- Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
- The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
- The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
- The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion
Key exclusion criteria (12 listed)
- Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion
- Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
- Personal history or diagnostic of following diseases:
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 |
|---|---|---|
| Karinat | Dietary supplement | Karinat |
| PlaceboSugar pill manufactured to mimic Karinat 500 mg tablet | Drug | Sugar pill |
Primary outcome
B-mode ultrasound of carotid arteries
Time frame: up to 2 years
Variation of intima-media thickness of common carotid arteries
1 secondary outcome
Measure of serum atherogenicity
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Karinat in people with Atherosclerosis, run by Institute for Atherosclerosis Research, Russia.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
B-mode ultrasound of carotid arteries (time frame: up to 2 years). 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 6 Dec 2012.