NCT05206058

Brief Summary

To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

September 1, 2023

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

January 23, 2022

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    After neutrophil isolation, an average of 3 months

Interventions

venipuncturePROCEDURE

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.

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Voluntary healthy donor (20-35 years old) do not have coagulopathy, systemic infective disease and severe liver and renal function impairment.

You may qualify if:

  • Healthy volunteers who aged 20-35 years.
  • Do not have coagulopathy, systemic infection disease and severe liver and renal function impairment
  • Accept venipuncture

You may not qualify if:

  • Healthy volunteers who aged over 35 years.
  • Have coagulopathy, systemic infection disease and severe liver and renal function impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Seperation of human neutrophils were according to a standardized procedures and following steps: using 3%(w/v) dextran sedimentation for 30 min, then gradient centrifugation in Ficoll-Hypaque, and hypotonic lysis of erythrocytes. The purified neutrophils were determined by the Trypan blue exclusion method and need to contained \>98% viable cells. Then they were suspended in without calcium ion HBSS buffer (pH 7.4), and stored at 4 °C for analysis

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

January 25, 2022

Study Start

January 1, 2022

Primary Completion

September 30, 2022

Study Completion

July 31, 2023

Last Updated

September 1, 2023

Record last verified: 2022-01

Locations