Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
|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: NCT04599348|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia CFS||Dietary Supplement: HRG 80 Red Ginseng||Early Phase 1|
Ginseng has been shown in earlier studies to help fatigue in a number of conditions. But because of overharvesting, most ginseng is no longer have optimal levels of the active ginsenosides. A new technique has been developed to restore the level of active ginseng components those found in the wild ginseng used in earlier studies. This is available in a form called HRG 80 Red Ginseng.
The study is an open pilot study to explore whether this treatment would be helpful for improving clinical function and symptomatology in chronic fatigue syndrome and fibromyalgia. Current clinical experience is suggesting that it may be.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label study|
|Masking:||None (Open Label)|
|Official Title:||Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng|
|Actual Study Start Date :||October 14, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Active Ginseng treatment
People with CFS or Fibromyalgia will receive HRG 80 Red GInseng
Dietary Supplement: HRG 80 Red Ginseng
A unique form of ginseng with the high level of active ginseng components similar to those found in the wild ginseng used in earlier studies.
- Composite Visual analog scale of symptoms [ Time Frame: 6 weeks ]Composite Score visual analog scale (0 - 30 Visual analog scale units , with 30 VAS units representing optimal function) of energy, cognition, and overall well-being. Each on a 0-10 scale with 10 being healthy. The units are the same for all 3 allowing them to be combined into a single composite total score. This total score (0-30 with 30 being the best outcome ) is the primary outcome measure
- VAS of pain and sleep [ Time Frame: 6 weeks ]VAS of pain and sleep
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): NCT04599348
|Contact: Jacob Teitelbaum, MD||4105627409||FatigueDoc@gmail.com|
|United States, Hawaii|
|Kona Research Center||Recruiting|
|Kailua, Hawaii, United States, 96740|
|Contact: Jacob Teitelbaum 410-562-7409 FatigueDoc@gmail.com|
|Principal Investigator:||Jacob Teitelbaum||FFTF LLC|