Dose escalation in healthy volunteers for subsequent Phase II trial of use in sickle cell disease and osteoarthritis Other
Conditions
Interventions
The intervention is African Bitter Root Supplement (ABRS), a herbal food supplement.
The methodology is a 3+3 dose escalation trial.
Trial setup:
1. Start the trial and enrol an initial cohort of 3 p
these are pre-randomised by the manufacturer as to which pack contains ABRS and which contains placebo.
3. Administer doses according to protocol. The participant takes all of pack A, waits the washou
Sponsors
Deep Life Medical Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this trial, an individual must meet all the following criteria at the time of joining the trial, in addition to not meeting any of the exclusion criteria: 1. Literate in English, able to understand the PIL, Consent and Reporting forms provided 2. Have the capacity to make an informed decision without pressure 3. Be over the age of 18 years or the age of majority, whichever is the higher, and under the age of 90 years 4. Be willing to participate in the Trial and report 5. Free of any acute health issue 6. If a participant is of childbearing potential, it shall be confirmed that the participant is on a long-acting reversible contraception (LARC) or another form of reliable contraception
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this trial if they do not meet the inclusion criteria above, or are: 1. Minors meaning any person under the age of 18 or under the age of majority, whichever is the highest 2. With any drug dependency 3. In a vulnerable population (unable to give informed consent, prisoners etc) 4. Pregnant women 5. Having known allergies to medication 6. The PI’s professional liability insurance excludes the USA so no participants may be enrolled who are in the USA or who hold passports from the USA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerable dose measured using 3+3 dose escalation using modified Fibonacci sequence at the conclusion of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate side effects or tolerability issues measured using report of adverse events at the conclusion of the trial | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactAlex Deas
Outcome results
None listed