A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.

NCT06473246 | Recruiting

• 1 other identifier: SE/230302/CBD/SS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.

Conditions

Healthy Population

Outcome Measures

Primary Outcomes (9)

• To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Fasting Glucose normal range is 74 - 106 mg/dL

  Day -5 to Day -1

• To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Fasting Glucose normal range is 74 - 106 mg/dL

  Day 90

• To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Fasting Glucose normal range is 74 - 106 mg/dL

  Day 180

• To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL

  Day -5 to Day -1

• To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL

  Day 90

• To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Estimated Glomerular Filtration Rate (eGFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL eGFR: 60 - 200 mL/min/1.73 m² Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL

  Day 180

• To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L

  Day -5 to -1

• To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L

  Day 90

• To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.

  Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L

  Day 180

Secondary Outcomes (18)

• To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count (CBC).

  Day -5 to Day -1, 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.

  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)

  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)

  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

  Day 0, Day 90, Day 180 and Day 195

Study Arms (5)

CBD Isolate (25 mg/0.5 ml)

ACTIVE COMPARATOR

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Dietary Supplement: CBD Isolate (25 mg/0.5 ml)

CBD Isolate (40 mg/0.5 ml)

ACTIVE COMPARATOR

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Dietary Supplement: CBD Isolate (40 mg/0.5 ml)

CBD Isolate (50 mg/0.5 ml)

ACTIVE COMPARATOR

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Dietary Supplement: CBD Isolate (50 mg/0.5 ml)

CBD Broad Extract (50 mg/0.5 ml)

ACTIVE COMPARATOR

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Dietary Supplement: CBD Broad Extract (50 mg/0.5 ml)

Placebo

PLACEBO COMPARATOR

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Dietary Supplement: Placebo

Interventions

CBD Isolate (25 mg/0.5 ml) DIETARY_SUPPLEMENT

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Isolate (25 mg/0.5 ml)

CBD Isolate (40 mg/0.5 ml) DIETARY_SUPPLEMENT

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Isolate (40 mg/0.5 ml)

CBD Isolate (50 mg/0.5 ml) DIETARY_SUPPLEMENT

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Isolate (50 mg/0.5 ml)

CBD Broad Extract (50 mg/0.5 ml) DIETARY_SUPPLEMENT

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

CBD Broad Extract (50 mg/0.5 ml)

Placebo DIETARY_SUPPLEMENT

0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male \& female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• 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)
• Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.
• 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.
• A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention

You may not qualify if:

• 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.
• Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
• Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
• Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.
• Individuals with SBP ≥ 160 mmHg and DBP ≥ 100 mmHg.
• Individuals on anti-hypertensives.
• History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by:
• For men, consuming more than 4 drinks on any day or more than 14 drinks/week
• For women, consuming more than 3 drinks on any day or more than 7 drinks/week
• Peri and post-menopausal women with no menstrual cycle in the last 6 months
• Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration
• 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
• Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
• Individual with a history and/or currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.
• 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

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (6)

Shivam Hospital

Dombivali, Maharashtra, 421203, India

RECRUITING

Dhanwantri Hospital

Pune, Maharashtra, 411011, India

RECRUITING

Vedant Multispeciality Hospital

Pune, Maharashtra, 411019, India

RECRUITING

Punawale Hospital

Pune, Maharashtra, 411033, India

RECRUITING

Vishwaraj Hospital

Pune, Maharashtra, 412201, India

RECRUITING

Shree Ashirwad Hospital

Thane, Maharashtra, 421201, India

RECRUITING

Central Study Contacts

Dr Sanjay Vaze, MBBS

CONTACT

8655670964; sanjay.v@vediclifesciences.com

Dr. Lalit Pawaskar, M.Pharm, PhD

CONTACT

7738418890; lalit.p@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind and Placebo controlled

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 25, 2024
• Study Start: February 20, 2025
• Primary Completion: January 5, 2026
• Study Completion: February 5, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)