FibromyalgiaEarly Phase 1NCT04599348
Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
A Early Phase 1 study testing HRG 80 Red Ginseng in people with Fibromyalgia and CFS, run by Practitioners Alliance Network at 1 site in United States.
Trial summary
Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, CFS
- What is being tested?
- HRG 80 Red Ginseng
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 30 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be diagnosed with CFS and/or fibromyalgia
- live in the United States 3 - be over 18 years of age
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kona Research Center
Kailua, Hawaii, 96740
Jacob Teitelbaum, 410-562-7409, FatigueDoc@gmail.com
About this study
Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?
Read the 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.
- Conditions
- Fibromyalgia, CFS
- Being tested
- HRG 80 Red Ginseng
- Keywords
- Ginseng
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG 80 Red GinsengDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Ginseng treatment | Experimental | People with CFS or Fibromyalgia will receive HRG 80 Red GInseng Receives: Dietary Supplement: HRG 80 Red Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
VAS of pain and sleep
VAS of pain and sleep
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start14 Oct 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Practitioners Alliance Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Teitelbaum, Practitioners Alliance Network
- Investigators
- Jacob Teitelbaum, Principal investigator, FFTF LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599348
- Sponsor's protocol ID
- PAN-HRG80-2020
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
- ClinicalTrials.gov ID
- NCT04599348
- Acronym / sponsor ID
- PAN-HRG80-2020
- Conditions
- Fibromyalgia, CFS
- Keywords
- Ginseng
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Practitioners Alliance NetworkUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| Active Ginseng treatment | Experimental | Dietary Supplement: HRG 80 Red GinsengPeople with CFS or Fibromyalgia will receive HRG 80 Red GInseng |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be diagnosed with CFS and/or fibromyalgia
- live in the United States 3 - be over 18 years of age
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRG 80 Red GinsengA unique form of ginseng with the high level of active ginseng components similar to those found in the wild ginseng used in earlier studies. | Dietary supplement | Active Ginseng treatment |
Primary outcome
Composite Visual analog scale of symptoms
Time frame: 6 weeks
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
1 secondary outcome
VAS of pain and sleep
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Teitelbaum principal investigator
FFTF LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HRG 80 Red Ginseng in people with Fibromyalgia and CFS, run by Practitioners Alliance Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Teitelbaum, MD (4105627409, FatigueDoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Visual analog scale of symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.