A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
NCT ID: NCT06473246
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-02-20
2026-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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CBD Isolate (25 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (25 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (40 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (40 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (50 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (50 mg/0.5 ml)
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)
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)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Placebo
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Placebo
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Interventions
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CBD Isolate (25 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (40 mg/0.5 ml)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
CBD Isolate (50 mg/0.5 ml)
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)
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Placebo
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Not a woman of childbearing potential (WOCBP)
2. 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
* 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:
1. For men, consuming more than 4 drinks on any day or more than 14 drinks/week
2. 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
* Individuals have taken sleep medication within 2 weeks prior to screening
* Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing
* Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.5 times upper limit of normal (ULN)
* Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline
* Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
18 Years
55 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shivam Hospital
Dombivali, Maharashtra, India
Dhanwantri Hospital
Pune, Maharashtra, India
Vedant Multispeciality Hospital
Pune, Maharashtra, India
Punawale Hospital
Pune, Maharashtra, India
Vishwaraj Hospital
Pune, Maharashtra, India
Shree Ashirwad Hospital
Thane, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Dr. Kushal Bangar, MBBS, MD (Medicine)
Role: primary
Dr. Bharat Jain, MBBS, DNB
Role: primary
Dr. Abhishek Karmalkar, MBBS, MD (Medicine)
Role: primary
Dr. Rajkumar Nikalje, MBBS, MD (Medicine)
Role: primary
Dr Namdev Jagtap, MBBS, MD
Role: primary
Dr. Deepak Varade, MBBS, DNB
Role: primary
Other Identifiers
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SE/230302/CBD/SS
Identifier Type: -
Identifier Source: org_study_id