RecruitingInterventional

Phase I clinical trial to determine maximum tolerable dose of African Bitter Root Food Supplement

We are conducting a study to find out the safest dose of a traditional herbal remedy called African Bitter Root Supplement (ABRS). This supplement has been used for many years in Nigeria and is sold legally in the UK. Many people use ABRS for conditions like sickle cell disease and osteoarthritis, but we don't yet have scientific proof that it works. Before we can test if it helps with these conditions, we need to know what a safe dose is. This study will involve healthy volunteers aged 18 to 90. You will take a small amount of either ABRS or a dummy capsule. We will carefully check for any side effects. Your participation will help us gather important safety information, even though it won't directly benefit your health.

At a glance

Status

Recruiting

Sponsor

Deep Life Medical Ltd

Enrolment target

Start

20 May 2026

Estimated completion

20 Jul 2026

Dose escalation in healthy volunteers for subsequent Phase II trial of use in sickle cell disease and osteoarthritis

What is this study about?

This study is all about understanding a traditional herbal supplement called African Bitter Root Supplement (ABRS). For a very long time, people in South Eastern Nigeria have used ABRS as a traditional remedy. It's made from a specific dried plant root, a natural clay, and a little bit of salt. You can currently buy ABRS legally as a food supplement here in the UK and across Europe.

Some people who have conditions like sickle cell disease or osteoarthritis use ABRS. However, up until now, there hasn't been much scientific research or clinical trials to show whether it actually helps them. Our first step is to figure out how much of this supplement can be taken safely. The main goal of this study is to find the highest amount of ABRS that doesn't cause any unwanted side effects. Knowing this safe dose is incredibly important before we can even think about doing larger studies to see if ABRS has any real health benefits.

By taking part, you'll be helping us gather vital safety information. This will allow researchers to properly design future studies and explore whether ABRS could make a difference for people with certain health conditions. Even though you won't get a direct health benefit from taking part, your contribution is valuable to future research.

Key takeaways

This study aims to find the safest dose of a traditional herbal supplement.
It's for healthy volunteers aged 18-90 years old.
Participation involves two doses a week apart, medical checks, and follow-up calls.
You won't get direct health benefits, but your help is vital for future research.
Safety is a top priority, with careful monitoring and quick contact options.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy volunteer between 18 and 90 years old. You should understand English well enough to read and sign forms, and be able to make your own decision to take part without feeling pressured. You also shouldn't have any current health problems at the time you join.

If you are a woman who could become pregnant, you'll need to confirm that you are using a reliable form of contraception. This is a standard safety measure for studies like this.

You cannot join the study if you are under 18, have any drug dependencies, are pregnant, or have known allergies to medications. Also, due to insurance rules, people currently in or holding passports from the USA cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 90 years old?
Can you read and understand information in English clearly?
Do you feel healthy right now, without any current illnesses?
If you are a woman who could become pregnant, are you using reliable contraception?
Are you not dependent on any drugs?
Are you not pregnant and do not have any known allergies to medicines?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll have a few appointments. First, a doctor will do a basic health check, including looking at your heart, blood pressure, and taking standard blood tests. If you're a woman who could become pregnant, the blood test will also include a pregnancy test. You'll also have an ECG, which checks your heart's electrical activity. You'll get your results as soon as they're ready.

You will be given two sealed tubs, labelled A and B, each with 16 capsules. One tub contains the African Bitter Root Supplement (ABRS) and the other contains a dummy capsule (a placebo) – you won't know which is which. You'll take all 16 capsules from Tub A on one day, either with a researcher watching or on a video call. Then, you'll wait 7 days. After this week, you'll take all 16 capsules from Tub B, again with a researcher present or on a video call. This 7-day break is for safety. You can swallow the capsules whole or open them and mix the contents with water. You need to take them on an empty stomach, at least an hour before you eat. There are a lot of capsules because ABRS is quite weak, and most of the capsule content is a natural clay.

After you've taken both sets of capsules, you'll have a second doctor's appointment on the 8th day to make sure your health hasn't changed. You'll also get these results. We will contact you (by phone, text, or email) before you take your dose, 30 minutes and 1 hour afterwards, and then again after 1 day and 1 week. We'll ask you a few questions about how you're feeling. The study is expected to run from May to July 2026.

Potential risks and benefits

You won't directly benefit your health from taking part in this study. However, your involvement is very important as it will help us gather safety information that could benefit people in the future who use ABRS. This data is also crucial for allowing proper scientific research into whether ABRS actually has any health benefits. ABRS has been used for many generations without serious safety worries, and lab tests show its components are within safe food limits. Any potential side effects are expected to be minor and clear up within 24 hours because the active parts dissolve in water and leave the body quickly. The 7-day gap between doses adds an extra layer of safety. If you feel unwell at any time, you must contact the study team immediately. You are always free to stop participating in the study at any point without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Deep Life Medical Ltd
Unverified
Musselburgh, Scotland

Common questions

What is African Bitter Root Supplement (ABRS)?

It's a traditional herbal remedy from Nigeria, made from a plant root, natural clay, and salt. It's sold as a food supplement in the UK.

Why are you doing this study?

We need to find out the highest safe dose of ABRS in healthy people. This information is key before we can study if it helps with conditions like sickle cell disease.

Will I know if I'm taking ABRS or a dummy capsule?

No, you won't know. You'll get two tubs, and one has ABRS while the other has a dummy capsule.

How long will I be involved in the study?

You'll have an initial check-up, take two doses a week apart, and then a final check-up on day 8. We'll also contact you for updates.

What if I feel unwell during the study?

You should contact the study team immediately. If you feel seriously unwell, seek medical attention right away and then contact the Principal Investigator.

How to find out more

Alex Deas

compliance@deeplifemedical.com +44 (0)7563617237 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.