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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03429231
Other study ID # QUbiquinol17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 23, 2017
Est. completion date April 15, 2018

Study information

Verified date May 2018
Source Instituto Palacios
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol
Patients in the active group will take one tablet a day orally

Locations

Country Name City State
Spain Instituto Palacios Madrid

Sponsors (1)

Lead Sponsor Collaborator
Dr. Santiago Palacios

Country where clinical trial is conducted

Spain, 

Outcome

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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