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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
Sponsor:
Information provided by (Responsible Party):
Jacob Teitelbaum, Practitioners Alliance Network

Study Description
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Brief Summary:
Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?

Condition or disease Intervention/treatment Phase
Fibromyalgia CFS Dietary Supplement: HRG 80 Red Ginseng Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Ginseng

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. VAS of pain and sleep [ Time Frame: 6 weeks ]
    VAS of pain and sleep


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be diagnosed with CFS and/or fibromyalgia
  2. live in the United States 3 - be over 18 years of age

Exclusion Criteria:

  • Pregnancy
Contacts and Locations
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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): NCT04599348


Contacts
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Contact: Jacob Teitelbaum, MD 4105627409 FatigueDoc@gmail.com

Locations
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United States, Hawaii
Kona Research Center Recruiting
Kailua, Hawaii, United States, 96740
Contact: Jacob Teitelbaum    410-562-7409    FatigueDoc@gmail.com   
Sponsors and Collaborators
Practitioners Alliance Network
Investigators
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Principal Investigator: Jacob Teitelbaum FFTF LLC
More Information
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Responsible Party: Jacob Teitelbaum, Principal investigator, Practitioners Alliance Network
ClinicalTrials.gov Identifier: NCT04599348    
Other Study ID Numbers: PAN-HRG80-2020
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacob Teitelbaum, Practitioners Alliance Network:
Ginseng
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases