Recruiting

Celastrol

Sponsor:

Legend Labz, Inc.

Code:

NCT05494112

Conditions

Safety

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Celastrol

Study Details

Brief summary:

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.

Conditions

Safety

Study ID

NCT05494112

Start date

May 25, 2022

Status verified date

Aug, 2022

Completion date

May 25, 2023

Anticipated

Primary completion date

May 25, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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.
2. 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
3. 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.
4. Women with tubal ligations or other physical conditions that make it impossible to conceive.
5. Women who are not pregnant or breast-feeding.

Exclusion Criteria:

1. Individuals who have been involved in any other clinical trial during the last 45 days.
2. 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.
3. Women who are pregnant or breast-feeding
4. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
5. Individuals on medications that the clinician feels may interfere with the results
6. Medications that might interfere with blood chemistry, CBCs, or vital signs.
7. Subjects who are taking daily medications. The use of therapies prn, such as headache and allergy medication are allowed.
8. Subjects Less than 18 years of age
9. Prisoners
10. Subjects who have taken anabolic steroid use during the last six months.
11. Subjects with a current history of addictive alcohol or illegal drug abuse (e.g. cocaine, heroin, etc.). The use of marijuana is allowed.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Amount of Celastrol Administered

Chronic evaluation of the same doses of Celastrol to each subject over 90-day period

Interventions

Celastrol

same dose of Celastrol will be given every day for a period of 90-days to all participants.

Primary outcome measure

  • The effect of celastrol on the function of the liver [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Patient Plus Urgent Care

Recruiting

Baton Rouge, Louisiana, United States, 70810

Contacts

Principal Investigator:

Rubin Patel, MD

More Information

Sponsor

Legend Labz, Inc.

Last update posted

Aug 9, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Legend Labz, Inc. on 2022-08-09.