NCT04598243

Brief Summary

Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 15, 2020

Last Update Submit

October 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    4-6 weeks

Study Arms (1)

Treatment of CFS/FMS with the nutritional combination

EXPERIMENTAL
Dietary Supplement: Smart Energy System

Interventions

Smart Energy SystemDIETARY_SUPPLEMENT

A nutritional /herbal combination

Treatment of CFS/FMS with the nutritional combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Diabetes
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kona Research Center

Kailua, Hawaii, 96740, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Jacob Teitelbaum, MD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

October 14, 2020

Primary Completion

July 4, 2021

Study Completion

July 4, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations