CBD safety check: new study tests supplement in 200 healthy adults
NCT ID NCT06473246
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing the safety of a CBD supplement called VL-SE-01 in 200 healthy adults aged 18 to 55. Participants will take one of four different doses of CBD or a placebo daily for 180 days. The main goal is to check blood markers for kidney, liver, and blood sugar health, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CBD (cannabidiol) isolate and broad extract
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 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: * 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: 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dhanwantri Hospital
RECRUITINGPune, Maharashtra, 411011, India
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Punawale Hospital
RECRUITINGPune, Maharashtra, 411033, India
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Shivam Hospital
RECRUITINGDombivali, Maharashtra, 421203, India
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Shree Ashirwad Hospital
RECRUITINGThane, Maharashtra, 421201, India
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Vedant Multispeciality Hospital
RECRUITINGPune, Maharashtra, 411019, India
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Vishwaraj Hospital
RECRUITINGPune, Maharashtra, 412201, India
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