Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Fibromyalgia Clinical Trial

Official title:

Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04599348
• Other study ID #: PAN-HRG80-2020
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 14, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2020
• Source: Practitioners Alliance Network
• Contact: Jacob Teitelbaum, MD
• Phone: 4105627409
• Email: FatigueDoc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CFS
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Kona Research Center	Kailua	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Practitioners Alliance Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	VAS of pain and sleep	VAS of pain and sleep	6 weeks