A Sub-Chronic Evaluation of the Safety of Celastrol in Human Subjects
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 Start (Actual) 25 May 2022
🗓️ Primary Completion (Estimated) 25 May 2023
✅ Study Completion (Estimated) 25 May 2023
👥 Enrollment (Estimated) 35
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baton Rouge, Louisiana, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 40 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 August 2022
  • First Submitted that Met QC Criteria 8 August 2022
  • First Posted 9 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 August 2022
  • Last Update Posted 9 August 2022
  • Last Verified August 2022