Health Status Clinical Trial
Official title:
Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol
Verified date | May 2018 |
Source | Instituto Palacios |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it
Status | Completed |
Enrollment | 40 |
Est. completion date | April 15, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Postmenopausal woman between 45 and 65 years old - Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months - Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months Exclusión Criteria: - Patients with severe mental illness. - Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection - Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study. |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Palacios | Madrid |
Lead Sponsor | Collaborator |
---|---|
Dr. Santiago Palacios |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Quality of Life at 3 months | To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them. The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome. In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question. Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel. In other words, they should check 5 if they are completely agree and 0 they are completely disagree. If they are not completely agree or disagree, they should check the boxes in between | Baseline and 3 months | |
Secondary | Change from Baseline General Health at 3 months | Health Scale Euroqol EQ-5D will be used for this outcome | Baseline and 3 months | |
Secondary | Change from Baseline Mood at three months | An analogic scale will be used for this outcome in wich 0 points is the best mood and 10 points is worst mood | Baseline and 3 months | |
Secondary | Change from Baseline Cramps at three months | To assess changes in cramps in patients who had them, a general questionnaire about Cramps will be used to assess mainly the intensity and frequency of crambs. Regarding the intensity 0 is the lower pain and 10 is the worst pain | Baseline and 3 months |
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