NCT05304299

Brief Summary

This study will investigate the effects of lowering intraocular pressure by oral intake of Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure relief.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

March 4, 2022

Last Update Submit

March 22, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Intraocular pressure

    Intraocular pressure of both eyes will be assessed

    0 minutes (before given Cordyceps Cicadae Mycelia)

  • Intraocular pressure

    Intraocular pressure of both eyes will be assessed

    90 minutes after given Cordyceps Cicadae Mycelia

  • Blood pressure

    Both systolic and diastolic blood pressures will be assessed

    0 minutes (before given Cordyceps Cicadae Mycelia)

  • Blood pressure

    Both systolic and diastolic blood pressures will be assessed

    90 minutes after given Cordyceps Cicadae Mycelia

Study Arms (2)

Cordyceps Cicadae Mycelia only

EXPERIMENTAL

Only Cordyceps Cicadae Mycelia will be given.

Dietary Supplement: Cordyceps Cicadae Mycelia

Cordyceps Cicadae Mycelia with Taflotan (saflutan)

EXPERIMENTAL

Cordyceps Cicadae Mycelia with Taflotan (saflutan) will be given.

Dietary Supplement: Cordyceps Cicadae Mycelia

Interventions

Cordyceps Cicadae MyceliaDIETARY_SUPPLEMENT

Cordyceps Cicadae Mycelia will be given to test its potential for alleviation of high intraocular pressure.

Cordyceps Cicadae Mycelia onlyCordyceps Cicadae Mycelia with Taflotan (saflutan)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20 and 75 years old, regardless of gender.
  • Pre-test confirmation of high intraocular pressure.
  • Subjects should understand the trial and agree to join the project.

You may not qualify if:

  • Age under 20 or over 75 years.
  • Use intraocular pressure lowering drugs other than Taflotan (saflutan).
  • Using beta-blockers or diuretics.
  • Being pregnant.
  • Disabled individuals with specific diseases or malfunction, for example tumours at terminal stage, blindness.
  • Loss of self-consciousness and behavioral capacity.
  • Patients with major diseases.
  • Withdrawal criteria All subjects may withdraw at any time without any reason. The act of withdraw does not affect rights for them to seek medical advice or treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Han-Hsin Chang

Taichung, Taiwan

Location

Study Officials

  • Han-Hsin Chang, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 31, 2022

Study Start

March 10, 2020

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations