Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

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

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia; CFS
• Intervention / Treatment: Dietary supplement: HRG 80 Red Ginseng

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Visual analog scale of symptoms	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	VAS of pain and sleep	6 weeks

Collaborators and Investigators

• Sponsor: Practitioners Alliance Network
• Investigators: Principal Investigator: Jacob Teitelbaum, FFTF LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Ginseng
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PAN-HRG80-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No