Investigating the Effects of Mikei® Red Reishi Essence EX on the Immune System of Prostate Cancer Patients and Patients With Non-cancerous Conditions of the Prostate
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|ClinicalTrials.gov Identifier: NCT03589781|
Recruitment Status : Withdrawn (Covid 19 Pandemic - Unable to enroll patients)
First Posted : July 18, 2018
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: Mikei Red Reishi Essence EX Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Investigating the Effects of Mikei® Red Reishi Essence EX on the Immune System of Prostate Cancer Patients and Patients With Non-cancerous Conditions of the Prostate|
|Estimated Study Start Date :||November 5, 2020|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||March 1, 2021|
Experimental: Mikei Red Reishi Essence EX
There are two groups (50 participants total) in this clinical study, one group (35 participants) will be given Mikei® Red Reishi Essence EX product (Product Group).
Dietary Supplement: Mikei Red Reishi Essence EX
Dosage is 490 mg per capsule, 3 capsules twice a day with food or water. Total of 6 capsules per day.
Placebo Comparator: Placebo
Another group (15 participants) will be given the placebo (Placebo Group). Placebo is a pill that looks like a drug but has no drug or other active ingredients.
Dietary Supplement: Placebo
Matching placebo. Consume 3 capsules twice a day with food or water. Total of 6 capsules per day.
- Changes in the immune function of the prostate cancer patients and patients with non-cancerous prostate conditions by taking reishi extract product. The immune function will be analyzed using D2Dx test by measuring the relative IgG level in the blood. [ Time Frame: 6 months ]D2Dx test is a two-step blood test that can measure the amount of IgG antibody adsorbed to a gold nanoparticle. Using a goat anti-human IgG antibody, the relative amount of IgG against autoantibodies is detected.
- Correlation between the immune function as expressed in the IgG level in the blood and the disease status (determined by PSA, DRE changes, and Gleason score) of prostate cancer patients. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589781
|United States, Florida|
|Orlando Health Medical Group Urology|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Inoel Rivera, MD||Orlando Health Medical Group Urology|
|Principal Investigator:||Qun Huo, Ph.D.||University of Central Florida|