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Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

Primary Purpose

Fibromyalgia, CFS

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smart Energy System
Sponsored by
Practitioners Alliance Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

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:

  1. pregnancy
  2. Diabetes
  3. Hypertension

Sites / Locations

  • Kona Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of CFS/FMS with the nutritional combination

Arm Description

Outcomes

Primary Outcome Measures

VAS
A composite VAS of Fatigue, Pain, Sleep, Cognition and overall well-being. These are each on a 1-10 scale with the same units, with 10 being healthy. The composite sum total of all of these (0-50) will be used as a single outcome measure

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
October 20, 2020
Sponsor
Practitioners Alliance Network
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1. Study Identification

Unique Protocol Identification Number
NCT04598243
Brief Title
Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract
Official Title
Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract
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
July 4, 2021 (Anticipated)
Study Completion Date
July 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?
Detailed Description
Ribose has been shown to be very helpful in CFS and fibromyalgia. Many studies have also shown benefit for the symptoms of these conditions from Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract. The study is undertaken as an early open label study to check for the efficacy of a proprietary combination of these

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment of CFS/FMS with the nutritional combination
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Smart Energy System
Intervention Description
A nutritional /herbal combination
Primary Outcome Measure Information:
Title
VAS
Description
A composite VAS of Fatigue, Pain, Sleep, Cognition and overall well-being. These are each on a 1-10 scale with the same units, with 10 being healthy. The composite sum total of all of these (0-50) will be used as a single outcome measure
Time Frame
4-6 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 Diabetes Hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Teitelbaum, MD
Phone
4105627409
Email
FatigueDoc@gmail.com
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 Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

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