Flu-like SymptomsPhase 1NCT04674709
Evaluation of the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
A Phase 1 study testing Oleander 4X - single, Oleander 4X - double and Oleander 4X - quadruple in people with Flu-like Symptoms, run by Avila Herbals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu-like Symptoms
- What is being tested?
- Oleander 4X - single, Oleander 4X - double and Oleander 4X - quadruple
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 15 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr. William Ball offices
Roanoke, Virginia, 24017
William Ball, MD, 540-772-1006, roanokefamilymed@gmail.com
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
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.
Read more
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).
Read the 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, 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
- Being tested
- Oleander 4X - single, Oleander 4X - double, Oleander 4X - quadruple, Placebo
- Keywords
- Flu-like symptoms, Avila Herbals, Phoenix Biotechnology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleander 4X - singleDrug
Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
Oleander 4X - doubleDrug
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 - quadrupleDrug
Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.
PlaceboDrug
The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Safety of Oleander 4X HPUS | Placebo comparator | : To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group). Receives: Drug: Oleander 4X - single; Drug: Oleander 4X - double; Drug: Oleander 4X - quadruple; Drug: Placebo |
| Pharmacokinetics evaluation of Oleander 4X HPUS | Experimental | To evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo. Receives: Drug: Oleander 4X - single; Drug: Oleander 4X - double; Drug: Oleander 4X - quadruple; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, serious event, and any related reactions as assessed by CTCAE v5.0.
Measured: 1-7 days
proportion of subjects undergoing DLT events
Safety evaluation
Measured: 1-7 days
Secondary outcomes (4)
pharmacokinetic parameters - AreaUnderCUrve (AUCt) [Time Frame: 24 hours]
AUCt plasma concentration of oleander (using Oleandrin as the marker) during 24 hours after administration.
Measured: 0-24 hours
half-life (t1/2)
half-life (t1/2) of oleander extract (using Oleandrin as the marker) during 24 hours after administration.
Measured: 0-24 hours
maximum and minimum plasma concentration
maximum and minimum plasma concentration of oleander extract (using Oleandrin as the marker) during 24 hours after administration.
Measured: 0-24 hours
total body clearance (Cltot)
total body clearance (Cltot) of oleander extract (using Oleandrin as the marker) during 24 hours after administration.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start24 Nov 2020
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu-like SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled Phase I study that will investigate the safety and efficacy of OLEANDER 4X HPUS in Healthy Volunteers.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avila Herbals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa G Obiso, PhD, Study director, Avila Herbals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674709
- Sponsor's protocol ID
- AH-O4X-11-2020-01
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Oleander 4X in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04674709
- Acronym / sponsor ID
- AH-O4X-11-2020-01
- Conditions
- Flu-like Symptoms
- Keywords
- Flu-like symptoms, Avila Herbals, Phoenix Biotechnology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Avila HerbalsIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled Phase I study that will investigate the safety and efficacy of OLEANDER 4X HPUS in Healthy Volunteers.
| Arm | Type | Receives |
|---|---|---|
| Safety of Oleander 4X HPUS | Placebo comparator | Drug: Oleander 4X - single, Drug: Oleander 4X - double, Drug: Oleander 4X - quadruple, Drug: Placebo: To evaluate the clinical safety of OLEANDER 4X HPUS in healthy volunteers relative to the control arm (placebo group). |
| Pharmacokinetics evaluation of Oleander 4X HPUS | Experimental | Drug: Oleander 4X - single, Drug: Oleander 4X - double, Drug: Oleander 4X - quadruple, Drug: PlaceboTo evaluate the pharmacokinetics of OLEANDER 4X HPUS versus placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleander 4X - singleCohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days. | Drug | Pharmacokinetics evaluation of Oleander 4X HPUS, Safety of Oleander 4X HPUS |
| Oleander 4X - doubleCohort 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. | Drug | Pharmacokinetics evaluation of Oleander 4X HPUS, Safety of Oleander 4X HPUS |
| Oleander 4X - quadrupleCohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days. | Drug | Pharmacokinetics evaluation of Oleander 4X HPUS, Safety of Oleander 4X HPUS |
| PlaceboThe placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days | Drug | Pharmacokinetics evaluation of Oleander 4X HPUS, Safety of Oleander 4X HPUS |
Primary outcome
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
Safety evaluation
4 secondary outcomes
pharmacokinetic parameters - AreaUnderCUrve (AUCt) [Time Frame: 24 hours]
Time frame: 0-24 hours
half-life (t1/2)
Time frame: 0-24 hours
maximum and minimum plasma concentration
Time frame: 0-24 hours
total body clearance (Cltot)
Time frame: 0-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa G Obiso, PhD study director
Avila Herbals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oleander 4X - single, Oleander 4X - double and Oleander 4X - quadruple in people with Flu-like Symptoms, run by Avila Herbals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard J Obiso, PhD (800-936-0197, rik@obisoco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.