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Trial record 26 of 247 for:    essential oil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589781
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nikkei (Canada) Marketing Limited

Brief Summary:
The primary objective of this study is to determine the effects of Mikei® Red Reishi Essence EX extract powder on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Mikei Red Reishi Essence EX Dietary Supplement: Placebo Not Applicable

Detailed Description:
The purpose of this study is to determine the effects of Mikei® Red Reishi Essence EX, a natural supplementary dietary product, on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate. According to limited published scientific research and clinical studies, Reishi mushroom extract may support the body's immune function. According to cancer immunology research, at early stage of tumor development, the immune system can mount defensive actions to eliminate or inhibit tumor growth. This study is to examine the specific effect of Mikei® Red Reishi Essence EX on the immune function of prostate cancer patients and patients with non-cancerous conditions of the prostate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Other Names:
  • Ganoderma lucidum (fruiting body) extract
  • lingzhi

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male age between 50-85
  2. Diagnosed with prostate cancer or high-grade PIN within the last 24 months through the most recent biopsy; or patients who have a total PSA level above 4.0 but have not been diagnosed with prostate cancer yet
  3. Has not received any prostate cancer therapy including surgery, chemotherapy, hormone therapy, or radiation therapy
  4. Clinical Gleason score of the tumor is ≤6 for patients ≤70 years or ≤7 for >70 years; (non-applicable for non-cancer patients with elevated PSA or high-grade PIN)
  5. The clinical stage of the cancer is T1c or below (non-applicable for non-cancer patients with elevated PSA or high-grade PIN)
  6. The patients have been recommended for and placed under active surveillance without immediate treatment
  7. Able to provide written informed consent

Exclusion Criteria:

  1. Patients taking mushroom (including reishi) or other herbal products/natural supplements
  2. Patients with a known allergy to mushrooms
  3. Prisoners
  4. Patients who receive treatment with 5-alpha reductase inhibitors (finasteride [Propecia®, Proscar®,], or dutasteride [Avodart®) within 28 days prior to randomization are not eligible. The use of these drugs is not allowed during the patients' study participation.
  5. Patients with a history of non-cutaneous malignancy in the previous 5 years are not eligible.
  6. Patients taking warfarin, heparin, Aspirin >81mg/day, or other prescribed blood thinners: Reishi may increase the risk of bleeding.
  7. Patients with platelets levels below 139 X 103/ul or history of bleeding disorders
  8. Patients undergoing chemotherapy: Reishi may make some chemotherapy drugs less effective.
  9. Patients with any known immune disorder, including but not limited to HIV or other primary or secondary immune deficiency diseases, autoimmune diseases, history of or being considered for organ transplants, etc.
  10. Patients taking immunosuppressants (Corticosteroids, Calcineurin inhibitors, mTOR inhibitors, IMDH inhibitors, Biologics, Monoclonal antibodies): Reishi can stimulate immune responses.
  11. Patients taking cytochrome P450 2E1, 1A2, and 3A sensitive substrate drugs: Reishi may increase the risk of side effects of these drugs.
  12. Patient has total bilirubin >1.5 MG/DL, alanine aminotransferase (ALT) >51 U/L or aspartate aminotransferase (AST) >46 U/L.

Information from the National Library of Medicine

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


Contacts
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Contact: Belinda Wong 1-866-606-5342 research@nikkeicanada.com

Locations
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United States, Florida
AdventHealth Medical Group Urology Recruiting
Orlando, Florida, United States, 328031834
Contact: Felipe Valerio         
Contact: Kim Hartley         
Sponsors and Collaborators
Nikkei (Canada) Marketing Limited
Investigators
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Principal Investigator: Inoel Rivera, MD AdventHealth Medical Group Urology
Principal Investigator: Qun Huo, Ph.D. University of Central Florida

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Responsible Party: Nikkei (Canada) Marketing Limited
ClinicalTrials.gov Identifier: NCT03589781    
Other Study ID Numbers: RM5160
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases