NeutrophilNCT05206058
To Exam the Effects of Phyllanthus Niruri Extracts on Human Neutrophils
An observational study of Neutrophil and Phyllanthus Abnormis Poisoning, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neutrophil, Phyllanthus Abnormis Poisoning
- What is being tested?
- venipuncture
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Jul 2023
- Phase
- Observational
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Voluntary healthy donor (20-35 years old) do not have coagulopathy, systemic infective disease and severe liver and renal function impairment.
Who may be able to join
- Healthy volunteers who aged 20-35 years.
- Do not have coagulopathy, systemic infection disease and severe liver and renal function impairment
- Accept venipuncture
Who cannot join
- Healthy volunteers who aged over 35 years.
- Have coagulopathy, systemic infection disease and severe liver and renal function impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Exam the Effects of Phyllanthus Niruri Extracts (Corilagin, Phyllanthin and Brevifolin) on Human Neutrophils
To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils
Read the detailed description
Phyllanthus niruri extracts have anti-inflammatory effects in various cellular systems (monocytes, neutrophil). However, the underlying effects and mechanisms of Phyllanthus niruri extracts on neutrophils have not yet been investigated in detail.
In this study, first we would like to systemic exam the effects of corilagin, phyllanthin and brevifolin, three major active components, on human neutrophils.
Further to clarify whether Phyllanthus niruri extracts have any effect on neutrophils that may provide some insights on the ability of these compounds to modulate the innate immune response in acute organ injury.
- Conditions
- Neutrophil, Phyllanthus Abnormis Poisoning
- Being tested
- venipuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venipunctureProcedure or surgery
Plan to enroll 240 health people who are 20-35 years of age. People with received veinpuncture. Blood will be collected at time and drawn into Heparin-coated tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of superoxide anion release
Superoxide anion released from human neutrophils were determined by measuring ferricytochrome c reduction.The neutrophils were activated with fMLF (30 nM) and cytochalasin B(0.5 μg/mL) (fMLF/CB). Changes in absorbance that occurred at 550 nm were observed continuously using a double beam spectrophotometer. Superoxide anion level was calculated using the methods described in previous report.
Measured: After neutrophil isolation, an average of 3 months
Measurement of intracellular ROS formation
Neutrophil ROS production was determined from the conversion of non-fluorescent DHR 123 to fluorescent rhodamine 123, detected using flow cytometry. Neutrophils (2 × 106 cells/ml) were incubated with DHR 123 (2 μM) for 15 min at 37°C, and then treated with honokiol (0.1-10 μM) for 5 min before the addition of fMLP/CB (0.5 μg/ml) for a further 5 min. The change in fluorescence was analysed using flow cytometry
Measured: After neutrophil isolation, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutrophilStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206058
- Sponsor's protocol ID
- 202002189B0
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Exam the Effects of Phyllanthus Niruri Extracts (Corilagin, Phyllanthin and Brevifolin) on Human Neutrophils
- ClinicalTrials.gov ID
- NCT05206058
- Acronym / sponsor ID
- 202002189B0
- Conditions
- Neutrophil, Phyllanthus Abnormis Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Jan 2022 (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.
To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils
Detailed description
Phyllanthus niruri extracts have anti-inflammatory effects in various cellular systems (monocytes, neutrophil). However, the underlying effects and mechanisms of Phyllanthus niruri extracts on neutrophils have not yet been investigated in detail.
In this study, first we would like to systemic exam the effects of corilagin, phyllanthin and brevifolin, three major active components, on human neutrophils.
Further to clarify whether Phyllanthus niruri extracts have any effect on neutrophils that may provide some insights on the ability of these compounds to modulate the innate immune response in acute organ injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Voluntary healthy donor (20-35 years old) do not have coagulopathy, systemic infective disease and severe liver and renal function impairment.
Key inclusion criteria (3 listed)
- Healthy volunteers who aged 20-35 years.
- Do not have coagulopathy, systemic infection disease and severe liver and renal function impairment
- Accept venipuncture
Key exclusion criteria (2 listed)
- Healthy volunteers who aged over 35 years.
- Have coagulopathy, systemic infection disease and severe liver and renal function impairment
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 |
|---|---|---|
| venipuncturePlan to enroll 240 health people who are 20-35 years of age. People with received veinpuncture. Blood will be collected at time and drawn into Heparin-coated tube. | Procedure or surgery | – |
Primary outcome
Measurement of superoxide anion release
Time frame: After neutrophil isolation, an average of 3 months
Superoxide anion released from human neutrophils were determined by measuring ferricytochrome c reduction.The neutrophils were activated with fMLF (30 nM) and cytochalasin B(0.5 μg/mL) (fMLF/CB). Changes in absorbance that occurred at 550 nm were observed continuously using a double beam spectrophotometer. Superoxide anion level was calculated using the methods described in previous report.
Measurement of intracellular ROS formation
Time frame: After neutrophil isolation, an average of 3 months
Neutrophil ROS production was determined from the conversion of non-fluorescent DHR 123 to fluorescent rhodamine 123, detected using flow cytometry. Neutrophils (2 × 106 cells/ml) were incubated with DHR 123 (2 μM) for 15 min at 37°C, and then treated with honokiol (0.1-10 μM) for 5 min before the addition of fMLP/CB (0.5 μg/ml) for a further 5 min. The change in fluorescence was analysed using flow cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutrophil and Phyllanthus Abnormis Poisoning, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Sep 2023. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of superoxide anion release (time frame: After neutrophil isolation, an average of 3 months). 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 1 Sep 2023.