Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

CBD safety check: new study tests supplement in 200 healthy adults

NCT ID NCT06473246

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy population are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dhanwantri Hospital

    RECRUITING

    Pune, Maharashtra, 411011, India

  • Punawale Hospital

    RECRUITING

    Pune, Maharashtra, 411033, India

  • Shivam Hospital

    RECRUITING

    Dombivali, Maharashtra, 421203, India

  • Shree Ashirwad Hospital

    RECRUITING

    Thane, Maharashtra, 421201, India

  • Vedant Multispeciality Hospital

    RECRUITING

    Pune, Maharashtra, 411019, India

  • Vishwaraj Hospital

    RECRUITING

    Pune, Maharashtra, 412201, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.