Recruiting
Phase 1

Oleander 4X HPUS

Sponsor:

Avila Herbals

Code:

NCT04674709

Conditions

Flu-like Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Oleander 4X - single

Oleander 4X - double

Oleander 4X - quadruple

Placebo

Study Details

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 primary purpose of this study is to assess the safety of Oleander 4X HPUS in health male and female subjects compared to a placebo. This is a randomized, double blind, placebo-controlled Phase I Proof of Concept clinical trial to evaluate the safety and efficacy of OLEANDER 4X HPUS in Healthy Volunteers. Briefly, 45 Healthy volunteers who meet the eligibility criteria and agree to participation in the study will be placed on 1.0 mL of OLEANDER 4X HPUS, four-to-twelve times per day for seven days. For the pharmacokinetics study (cohorts 4-6), participants will take OLEANDER 4X HPUS at a prescribed dose one time.

The aim of the present study is to evaluate the safety of OLEANDER 4X HPUS. This real-world cohort provides a unique opportunity to study this medicine. This protocol outlines a study involving Healthy volunteers. Up to 45 volunteers will be recruited in specific health systems in the USA.

Second ARM, sub-study: As a second arm of this study, a random double blind, placebo-controlled pharmacokinetics study in healthy volunteers. Briefly, 15 healthy volunteers who meet the same eligibility criteria and agree to participation in the study will be placed on one, two, or 4 doses (1 mL per dose) of OLEANDER 4X HPUS one time.

This is effectively three ascending doses in 4 subjects on OLEANDER 4X HPUS, compared to the placebo (1 subject).

Conditions

Flu-like Symptoms

Study ID

NCT04674709

Start date

Nov 24, 2020

Status verified date

Dec, 2020

Completion date

Jan 15, 2021

Anticipated

Primary completion date

Jan 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Safety of Oleander 4X HPUS

: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group).

experimental: Pharmacokinetics evaluation of Oleander 4X HPUS

To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo.

Interventions

Oleander 4X - single

Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.

Oleander 4X - double

Cohort 2 receive 2 doses of either active drug or placebo 4 times per day in a 24-hour period for a period of seven days.

Oleander 4X - quadruple

Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.

Placebo

The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days

Primary outcome measure

  • Number of participants with adverse events, serious event, and any related reactions as assessed by CTCAE v5.0. [ Time Frame: 1-7 days ]
  • proportion of subjects undergoing DLT events [ Time Frame: 1-7 days ]

Central Contacts and Locations

Central contacts

Richard J Obiso, PhD

800-936-0197rik@obisoco.com

Locations

Dr. William Ball offices

Recruiting

Roanoke, Virginia, United States, 24017

Contacts

William Ball, MD

540-772-1006roanokefamilymed@gmail.com

More Information

Sponsor

Avila Herbals

Last update posted

Dec 21, 2020

Last verified

Dec, 2020

Keywords

  • Flu-like symptoms
  • Avila Herbals
  • Phoenix Biotechnology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avila Herbals on 2020-12-21.