Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Early Phase 1

• Conditions: Fibromyalgia; CFS
• Interventions: Dietary Supplement: HRG 80 Red Ginseng

• Registration Number: NCT04599348
• Lead Sponsor: Practitioners Alliance Network

Brief Summary

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

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 Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-14
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Ginseng treatment	HRG 80 Red Ginseng	People with CFS or Fibromyalgia will receive HRG 80 Red GInseng

Primary Outcome Measures

Name	Time	Method
Composite Visual analog scale of symptoms	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

Name	Time	Method
VAS of pain and sleep	6 weeks	VAS of pain and sleep

Trial Locations

Locations (1)

Kona Research Center; 🇺🇸 Kailua, Hawaii, United States