Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Overview

Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 30, 2021

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.

Interventions

• 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.

Arms, Groups and Cohorts

• Experimental: Active Ginseng treatment
  • People with CFS or Fibromyalgia will receive HRG 80 Red GInseng

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• VAS of pain and sleep
  • Time Frame: 6 weeks
  • VAS of pain and sleep

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Practitioners Alliance Network
• Provider of Information About this Clinical Study
  • Principal Investigator: Jacob Teitelbaum, Principal investigator – Practitioners Alliance Network
• Overall Official(s)
  • Jacob Teitelbaum, Principal Investigator, FFTF LLC
• Overall Contact(s)
  • Jacob Teitelbaum, MD, 4105627409, FatigueDoc@gmail.com