NCT01741974

Brief Summary

The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal women.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

December 6, 2012

Status Verified

January 1, 2012

Enrollment Period

6.7 years

First QC Date

December 2, 2012

Last Update Submit

December 4, 2012

Conditions

Menopausal SyndromeAtherosclerosis

Keywords

perimenopausephytoestrogenatherosclerosisintima-media thickness

Outcome Measures

Primary Outcomes (1)

  • B-mode ultrasound of carotid arteries

    Variation of intima-media thickness of common carotid arteries

    up to 3 years

Secondary Outcomes (1)

  • Measure of serum atherogenicity

    up to 3 years

Study Arms (2)

Karinat

ACTIVE COMPARATOR

Karinat 500 mg tablet by mouth three times a day

Dietary Supplement: Karinat

Sugar pill

PLACEBO COMPARATOR

Placebo tablet 500 mg by mouth three times a day

Drug: Placebo

Interventions

KarinatDIETARY_SUPPLEMENT
Karinat
PlaceboDRUG

Sugar pill manufactured to mimic Karinat 500 mg tablet

Sugar pill

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Perimenopausal women aged 45 to 60 years with intact womb and ovaries
  • The absence of menstruations between 6 to 24 months
  • Last menstruation after the age of 40 years
  • Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
  • Mammography without nodal form of mastopathy or breast cancer signs

You may not qualify if:

  • Personal history or diagnostic of following diseases:
  • nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI \>30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 90 mmHg) current cigarette smoking (\>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism
  • Individual intolerance of Karinat or major side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atherosclerosis

Interventions

karinat

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 5, 2012

Study Start

October 1, 2005

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-01