Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

NCT04599348 | Unknown Early Phase 1

• 1 other identifier: PAN-HRG80-2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia; CFS

Keywords

Ginseng

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• VAS of pain and sleep

  6 weeks

Study Arms (1)

Active Ginseng treatment

EXPERIMENTAL

People with CFS or Fibromyalgia will receive HRG 80 Red GInseng

Dietary Supplement: HRG 80 Red Ginseng

Interventions

HRG 80 Red Ginseng DIETARY_SUPPLEMENT

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.

Active Ginseng treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Practitioners Alliance Network: lead

Study Sites (1)

Kona Research Center

Kailua, Hawaii, 96740, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jacob Teitelbaum

  FFTF LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Teitelbaum, MD

CONTACT

4105627409; FatigueDoc@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Open label study

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: October 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)