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

Primary Purpose

Supplement

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cordyceps Cicadae Mycelia
Sponsored by
Han-Hsin Chang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Supplement

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Han-Hsin Chang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cordyceps Cicadae Mycelia only

Cordyceps Cicadae Mycelia with Taflotan (saflutan)

Arm Description

Only Cordyceps Cicadae Mycelia will be given.

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

Outcomes

Primary Outcome Measures

Intraocular pressure
Intraocular pressure of both eyes will be assessed
Intraocular pressure
Intraocular pressure of both eyes will be assessed
Blood pressure
Both systolic and diastolic blood pressures will be assessed
Blood pressure
Both systolic and diastolic blood pressures will be assessed

Secondary Outcome Measures

Full Information

First Posted
March 4, 2022
Last Updated
March 22, 2022
Sponsor
Han-Hsin Chang
Collaborators
Grape King Bio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05304299
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han-Hsin Chang
Collaborators
Grape King Bio Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 The total recruitment of subjects is 60 people, aged between 20 to 75 years. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supplement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cordyceps Cicadae Mycelia only
Arm Type
Experimental
Arm Description
Only Cordyceps Cicadae Mycelia will be given.
Arm Title
Cordyceps Cicadae Mycelia with Taflotan (saflutan)
Arm Type
Experimental
Arm Description
Cordyceps Cicadae Mycelia with Taflotan (saflutan) will be given.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cordyceps Cicadae Mycelia
Intervention Description
Cordyceps Cicadae Mycelia will be given to test its potential for alleviation of high intraocular pressure.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Intraocular pressure of both eyes will be assessed
Time Frame
0 minutes (before given Cordyceps Cicadae Mycelia)
Title
Intraocular pressure
Description
Intraocular pressure of both eyes will be assessed
Time Frame
90 minutes after given Cordyceps Cicadae Mycelia
Title
Blood pressure
Description
Both systolic and diastolic blood pressures will be assessed
Time Frame
0 minutes (before given Cordyceps Cicadae Mycelia)
Title
Blood pressure
Description
Both systolic and diastolic blood pressures will be assessed
Time Frame
90 minutes after given Cordyceps Cicadae Mycelia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Hsin Chang, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Han-Hsin Chang
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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