- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599348
Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Jacob Teitelbaum, MD
- Phone Number: 4105627409
- Email: FatigueDoc@gmail.com
Study Locations
-
-
Hawaii
-
Kailua, Hawaii, United States, 96740
- Recruiting
- Kona Research Center
-
Contact:
- Jacob Teitelbaum
- Phone Number: 410-562-7409
- Email: FatigueDoc@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be diagnosed with CFS and/or fibromyalgia
- live in the United States 3 - be over 18 years of age
Exclusion Criteria:
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Ginseng treatment
People with CFS or Fibromyalgia will receive 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS of pain and sleep
Time Frame: 6 weeks
|
VAS of pain and sleep
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacob Teitelbaum, FFTF LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAN-HRG80-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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