Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
95 participants
INTERVENTIONAL
2022-07-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner
Placebo
300 mg olive oil
Low GG
LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner
Low GG
150 mg GG
High GG
HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner
High GG
300 mg GG
Interventions
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Placebo
300 mg olive oil
Low GG
150 mg GG
High GG
300 mg GG
Eligibility Criteria
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Inclusion Criteria
* Statin-treated patients with muscle pain alone or accompanied by other symptoms.
* Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase
Exclusion Criteria
* Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.
* Had CoQ10 supplement one month before starting the study.
* Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
* Had steroid medication one month before starting the study.
40 Years
ALL
Yes
Sponsors
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Texas Tech University Health Sciences Center
OTHER
Responsible Party
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Principal Investigators
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Chwan-Li (Leslie) Shen, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech Health Science Center
Locations
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Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L22-130
Identifier Type: -
Identifier Source: org_study_id
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