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

October 20, 2020 updated by: Practitioners Alliance Network
Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Hawaii
      • Kailua, Hawaii, United States, 96740
        • Recruiting
        • Kona Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment of CFS/FMS with the nutritional combination
Dietary supplement: Smart Energy System
A nutritional /herbal combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Practitioners Alliance Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Anticipated)

July 4, 2021

Study Completion (Anticipated)

July 4, 2021

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-SES 1-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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