Status:
UNKNOWN
Evaluation of the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
Lead Sponsor:
Avila Herbals
Conditions:
Flu-like Symptoms
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The homeopathic medicine, Oleander 4X HPUS is indicated for temporary relief of symptoms associated with flu, such as muscle or body aches, headaches, chills and fever, cough, and congestion. The prim...
Detailed Description
The aim of the present study is to evaluate the safety of OLEANDER 4X HPUS. This protocol outlines a study involving Healthy volunteers. Up to 45 volunteers will be recruited in the USA. Second ARM, ...
Eligibility Criteria
Inclusion
- Healthy Volunteers.
- Subjects with no symptoms of respiratory illness such as fever, rhinorrhea, mild cough, sore throat, headache, fatigue, muscle pain, and malaise but with no shortness of breath.
- Male or non-pregnant female adult \> 18 to 65 years of age at time of enrollment to include all races and ethnic minorities.
- Agree to the collection of blood specimens (for the pharmacokinetics study).
- Willingness of study participant to provide informed consent and accept randomization to any assigned treatment arm.
- Must agree not to enroll in another study of an investigational agent prior to Day 28 of study, unless hospitalized.
Exclusion
- Signs of any respiratory distress or pulmonary infection defined as the need for non-invasive or invasive mechanical ventilator support, ECMO or shock requiring vasopressor support.
- Subjects with risk factors for severe disease (e.g. hypertension, diabetes, pulmonary, cardiovascular, renal, hepatic, neurologic disease or immune compromise, obesity, and pregnancy).
- Any previous history of clinically significant cardiovascular disease, including ventricular arrhythmias.
- Current use of cardiac glycosides or a known allergic reaction to cardiac glycosides or compounds of similar chemical or biologic composition.
- Any risk factors that can lead to severe COVID-19 including uncontrolled diabetes, hypertension, and systemic diseases including hepatic disease and renal insufficiency.
- Pregnancy or breastfeeding.
- Participation in any other clinical trial of an experimental treatment for COVID-19.
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2021
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04674709
Start Date
November 24 2020
End Date
January 15 2021
Last Update
December 21 2020
Active Locations (1)
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1
Dr. William Ball offices
Roanoke, Virginia, United States, 24017