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Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Primary Purpose

Fibromyalgia, CFS

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
HRG 80 Red Ginseng
Sponsored by
Practitioners Alliance Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Ginseng

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kona Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Ginseng treatment

Arm Description

People with CFS or Fibromyalgia will receive HRG 80 Red GInseng

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS of pain and sleep
VAS of pain and sleep

Full Information

First Posted
October 15, 2020
Last Updated
October 21, 2020
Sponsor
Practitioners Alliance Network
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1. Study Identification

Unique Protocol Identification Number
NCT04599348
Brief Title
Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
Official Title
Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Practitioners Alliance Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, CFS
Keywords
Ginseng

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Ginseng treatment
Arm Type
Experimental
Arm Description
People with CFS or Fibromyalgia will receive HRG 80 Red GInseng
Intervention Type
Dietary Supplement
Intervention Name(s)
HRG 80 Red Ginseng
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Visual analog scale of symptoms
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
VAS of pain and sleep
Description
VAS of pain and sleep
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be diagnosed with CFS and/or fibromyalgia live in the United States 3 - be over 18 years of age Exclusion Criteria: Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Teitelbaum, MD
Phone
4105627409
Email
FatigueDoc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Teitelbaum
Organizational Affiliation
FFTF LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kona Research Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Teitelbaum
Phone
410-562-7409
Email
FatigueDoc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

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