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

Supplement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304299
• Other study ID #: IRB-19-024
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Hypertension
• Supplement

Intervention

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

Locations

Country	Name	City	State
Taiwan	Han-Hsin Chang	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Han-Hsin Chang	Grape King Bio Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	Intraocular pressure of both eyes will be assessed	0 minutes (before given Cordyceps Cicadae Mycelia)
Primary	Intraocular pressure	Intraocular pressure of both eyes will be assessed	90 minutes after given Cordyceps Cicadae Mycelia
Primary	Blood pressure	Both systolic and diastolic blood pressures will be assessed	0 minutes (before given Cordyceps Cicadae Mycelia)
Primary	Blood pressure	Both systolic and diastolic blood pressures will be assessed	90 minutes after given Cordyceps Cicadae Mycelia