Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia

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.

Study Overview

• Status: Completed
• Conditions: Supplement
• Intervention / Treatment: Dietary supplement: Cordyceps Cicadae Mycelia

Detailed Description

Study purpose This study investigated the effeicacy of oral Cordyceps cicadae mycelia for the relief of high intraocular pressure.

Subjects

1. The total recruitment of subjects is 60 people, aged between 20 to 75 years.
2. Subjects with intraocular pressure more than or equal to 21 mmHg are included, irrespective of whether on us of Taflotan (saflutan).

Methods

1. Informed consents will be obtained from subjects first. The subjects with pre-test intraocular pressure over or equal 21 mm Hg are advised to orally take two capsules containing a total of 500 mg of Cordyceps cicadae mycelia. After 90 minutes, the subjects are evaluated for intraocular pressure.

The pre-test and and post-intake intraocualr pressure and blood pressure data will be compared by paired t test for significant differences if any.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Han-Hsin Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Age under 20 or over 75 years.
2. Use intraocular pressure lowering drugs other than Taflotan (saflutan).
3. Using beta-blockers or diuretics.
4. Being pregnant.
5. Disabled individuals with specific diseases or malfunction, for example tumours at terminal stage, blindness.
6. Loss of self-consciousness and behavioral capacity.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cordyceps Cicadae Mycelia only; Only Cordyceps Cicadae Mycelia will be given.	Dietary supplement: Cordyceps Cicadae Mycelia; Cordyceps Cicadae Mycelia will be given to test its potential for alleviation of high intraocular pressure.
Experimental: Cordyceps Cicadae Mycelia with Taflotan (saflutan); Cordyceps Cicadae Mycelia with Taflotan (saflutan) will be given.	Dietary supplement: Cordyceps Cicadae Mycelia; Cordyceps Cicadae Mycelia will be given to test its potential for alleviation of high intraocular pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Han-Hsin Chang
• Collaborators: Grape King Bio Ltd.
• Investigators: Principal Investigator: Han-Hsin Chang, PhD, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension
• Other Study ID Numbers: IRB-19-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No