Patient ActivationNCT05689697
Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
A study testing PanTrek in people with Patient Activation, run by Ketonic Pharm LLC at 1 site in Russia.
Trial summary
The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\or mental exertion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient Activation
- What is being tested?
- PanTrek
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2023to 15 Aug 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- diagnosis of astenia and/or decreased tolerance to physical and\or mental exertion
- ability of patients to understand assessment procedures
Who cannot join
- intollerance of components of PanTrek
- participation in other trials
Trial locations and contacts
1 site in 1 country.
Russia1 site
Laboratory of psychopharmacology Research center of mental health
Moscow, 115522
Denis Burminsiy, MD, PhD, +79262344633, desbur@gmail.com
Allan Beniashvili, MD, PhD, +79859259676, beniashvilia@yandex.ru
About this study
Official title: Efficacy of Physiological Ketosis Induced by Liquid Technology Formula PanTrek in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion (Double-blind, Placebo-controlled Study)
The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.
Read the detailed description
It will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. Patients will be randomly assigned to one of two groups: placebo or IP group in 1:1 proportion. Study instruments: D-Fis, MoCA, TMT, VAS, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or PanTrek. PanTrek will be served in ampuls, 25 ml per ampule.
The duration of the study will be 15 days of treatment and 15 days of follow-up observation.
Patients will be assessed at screening/baseline, after 15 days and after 30 days.
The dose regimen: the shot of PanTrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.
- Conditions
- Patient Activation
- Being tested
- PanTrek
- Keywords
- Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid
- Medical subject headings
- Patient Participation, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanTrekDietary supplement
administration of exogenouse keton body
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients will recieve matched by taste and color shot of 25 ml liquid in ampules Receives: Dietary Supplement: PanTrek |
| Active treatment group | Experimental | Patients will recieve shot of PanTrek 25 ml in anpules Receives: Dietary Supplement: PanTrek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Difference of changes of visual analog scale (VAS) indices between active treament and placebo groups. Minimum value - 0, maximum value - 100 scores. The higher score means the better condition. The major difference means better outcome.
Measured: 15 days
Secondary outcomes (1)
indused ketosis
increase of ketons level from baseline to the end of the active treatment period of the study
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ActivationStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ketonic Pharm LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Burminskiy, MD, PhD, Study director, Mental health research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689697
- Sponsor's protocol ID
- KetonicPharm
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2022
- Last updated
- 19 Jan 2023
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physiological Ketosis Induced by Liquid Technology Formula PanTrek in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion (Double-blind, Placebo-controlled Study)
- ClinicalTrials.gov ID
- NCT05689697
- Acronym / sponsor ID
- KetonicPharm
- Conditions
- Patient Activation
- Keywords
- Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ketonic Pharm LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 19 Jan 2023 (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.
The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.
Detailed description
It will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. Patients will be randomly assigned to one of two groups: placebo or IP group in 1:1 proportion. Study instruments: D-Fis, MoCA, TMT, VAS, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or PanTrek. PanTrek will be served in ampuls, 25 ml per ampule.
The duration of the study will be 15 days of treatment and 15 days of follow-up observation.
Patients will be assessed at screening/baseline, after 15 days and after 30 days.
The dose regimen: the shot of PanTrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: PanTrekPatients will recieve matched by taste and color shot of 25 ml liquid in ampules |
| Active treatment group | Experimental | Dietary Supplement: PanTrekPatients will recieve shot of PanTrek 25 ml in anpules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- diagnosis of astenia and/or decreased tolerance to physical and\or mental exertion
- ability of patients to understand assessment procedures
Key exclusion criteria (2 listed)
- intollerance of components of PanTrek
- participation in other trials
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 |
|---|---|---|
| PanTrekadministration of exogenouse keton body | Dietary supplement | Active treatment group, Placebo group |
Primary outcome
Primary outcome
Time frame: 15 days
Difference of changes of visual analog scale (VAS) indices between active treament and placebo groups. Minimum value - 0, maximum value - 100 scores. The higher score means the better condition. The major difference means better outcome.
1 secondary outcome
indused ketosis
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- 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.
Denis Burminskiy, MD, PhD study director
Mental health research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PanTrek in people with Patient Activation, run by Ketonic Pharm LLC at 1 site in Russia.
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 3 inclusion and 2 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 19 Jan 2023. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Denis Burminskiy, MD, PhD (+79262344633, desbur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 15 days). 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 19 Jan 2023.