Clinical trial NCT05304299: Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia
Official title: Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplement
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2022-03-31
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 0 minutes (before given Cordyceps Cicadae Mycelia)
measure: Intraocular pressure
timeFrame: 90 minutes after given Cordyceps Cicadae Mycelia
measure: Blood pressure
timeFrame: 0 minutes (before given Cordyceps Cicadae Mycelia)
measure: Blood pressure
timeFrame: 90 minutes after given Cordyceps Cicadae Mycelia
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Han-Hsin Chang
Study officials:
affiliation: Chung Shan Medical University
name: Han-Hsin Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: