A Sub-Chronic Evaluation of the Safety of Celastrol in Human Subjects

Status unconfirmed · Not applicable

Conditions studied: Safety

In brief

This is an open label safety study that will not be blinded or placebo controlled. Purpose is to evaluate the safety of Celastrol in healthy men and women volunteers, between 18 and 40 years of age, over a 90-day period. Celastrol is different than Cholesterol. Cholesterol is a risk for heart disease. Celastrol is a natural occurring compound extracted from the root of Tripterygium wilfordii, a herb used in Chinese medicine.

Key facts

Study ID

NCT05494112

Run by

Legend Labz, Inc.

People needed

35

Starts

2022-05-25

Expected to finish

2023-05-25

Last updated by the study team

2022-08-09

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Individuals who are between 18 and 40 years of age and who are found to be healthy without any underlying medical conditions and are not taking any daily medications. This does not exclude patients who take drugs prn.
• Individuals who have not be involved in other clinical trials during the last 45 days. However, individuals that participated in the Celastrol-Sperm Health study can enter the trial after a seven day "wash-out" period
• Women of child-bearing age and ability who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent pregnancy; or are taking hormonal medication designed to prevent pregnancy, during the entire course of the study.
• Women with tubal ligations or other physical conditions that make it impossible to conceive.
• Women who are not pregnant or breast-feeding.

You may not qualify if…

• Individuals who have been involved in any other clinical trial during the last 45 days.
• Women of child-bearing age who do not agree to abstain from sexual intercourse, or do not agree to use condoms or vaginal diaphragms or other devices designed to prevent pregnancy, or who are not on hormonal medication designed to prevent pregnancy, during the entire course of the study.
• Women who are pregnant or breast-feeding
• Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
• Individuals on medications that the clinician feels may interfere with the results
• Medications that might interfere with blood chemistry, CBCs, or vital signs.
• Subjects who are taking daily medications. The use of therapies prn, such as headache and allergy medication are allowed.
• Subjects Less than 18 years of age
• Prisoners
• Subjects who have taken anabolic steroid use during the last six months.
• Subjects with a current history of addictive alcohol or illegal drug abuse (e.g. cocaine, heroin, etc.). The use of marijuana is allowed.

Where it is running

• Patient Plus Urgent Care — Baton Rouge, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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