None listed
Conditions
Interventions
Intervention1: VL-SE-01 - CBD Isolate (25 mg/ dose): 0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed for 180 Days.
Control Intervention1: VL-SE-01 - CBD Isolate (
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent. 2. Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg/m2 (inclusive). 4. Individuals with a stressed lifestyle as assessed by PSS scores within 27-40. 5. A male must agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period. 6. A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP). b) OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention.
Exclusion criteria
Exclusion criteria: 1. Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data. 2. Males who has a history of oligospermia, vasectomy and other sperm abnormalities. 3. Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome. 4. Individuals with Type 1 and Type 2 Diabetes mellitus and on medication. 5. Individuals with SBP more than or equal to 160 mmHg and DBP more than or equal to 100 mmHg. 6. Individuals on anti-hypertensives. 7. History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by: a) For men, consuming more than 4 drinks on any day or more than 14 drinks/week b) For women, consuming more than 3 drinks on any day or more than 7 drinks/week 8. Peri and post menopausal women with no menstrual cycle in the last 6 months. 9. Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration. 10. Individual has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol. 11. Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome. 12. Individual with a history and/or currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy. 13. Individual has past or intended use of prohibited medication or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing. 14. Individuals have taken sleep medication within 2 weeks prior to screening. 15. Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing. 16. Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) more than 1.5 times upper limit of normal (ULN). 17. Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). 18. Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline. 19. Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of VL-SE-01 by assessing the Complete Metabolic Panel (CMP) before and after IP consumption.Timepoint: Day 0, Day 90 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using blood, which includes Inflammation by analyzing CRP levels. Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using blood, which includes Hormonal profile (Luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, estradiol and progesterone)Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using blood, which includes Thyroid profile (T3, T4, TSH).Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using blood, which includes Lipid Profile as assessed by levels of total cholesterol, LDL, HDL and triglycerides.Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using blood, which includes Glomerular Filtration rateTimepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using Semen AnalysisTimepoint: Day 0 and Day 180;To assess safety and tolerability of VL-SE-01 using blood Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)] (will be conducted in 15 participants only in each group except placebo)Timepoint: Day 195;To assess the safety and tolerability of VL-SE-01 using Vitals like Blood Pressure, Heart rate/Pulse rate.Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using Electrocardiogram.Timepoint: Day 0, Day 90, Day 180 and Day 195;To assess the safety and tolerability of VL-SE-01 using Treatment emergent Adverse Events (TEAEs).Timepoint: Day 0, Day 90, Day 180 and Day 195;To evaluate the efficacy of VL-SE-01 on Plasma levels of CBD and its metabolites [7-Carboxycannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7- OH-CBD) | — |
Countries
India
Contacts
Public ContactDr. Lalit Pawaskar
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed