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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598243
Recruitment Status : Unknown
Verified October 2020 by Practitioners Alliance Network.
Recruitment status was:  Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Practitioners Alliance Network

Study Description
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Brief Summary:
Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Condition or disease Intervention/treatment Phase
Fibromyalgia CFS Dietary Supplement: Smart Energy System Early Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : July 4, 2021
Estimated Study Completion Date : July 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment of CFS/FMS with the nutritional combination Dietary Supplement: Smart Energy System
A nutritional /herbal combination


Outcome Measures
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Primary Outcome Measures :
  1. VAS [ Time Frame: 4-6 weeks ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598243


Contacts
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Contact: Jacob Teitelbaum, MD 4105627409 FatigueDoc@gmail.com

Locations
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United States, Hawaii
Kona Research Center Recruiting
Kailua, Hawaii, United States, 96740
Contact: Jacob Teitelbaum    410-562-7409    FatigueDoc@gmail.com   
Sponsors and Collaborators
Practitioners Alliance Network
More Information
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Responsible Party: Practitioners Alliance Network
ClinicalTrials.gov Identifier: NCT04598243    
Other Study ID Numbers: PAN-SES 1-2020
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases