Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
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)
1 other identifier
interventional
88
1 country
1
Brief 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. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedJanuary 19, 2023
December 1, 2022
6 months
December 23, 2022
January 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 days
Secondary Outcomes (1)
indused ketosis
15 days
Other Outcomes (4)
Improvement in cognitive function
15 days
Improvement in visual attention and task switching.
15 days
Improvement in physical function
15 days
- +1 more other outcomes
Study Arms (2)
Placebo group
PLACEBO COMPARATORPatients will recieve matched by taste and color shot of 25 ml liquid in ampules
Active treatment group
EXPERIMENTALPatients will recieve shot of PanTrek 25 ml in anpules
Interventions
Eligibility Criteria
You may qualify if:
- informed consent
- diagnosis of astenia and/or decreased tolerance to physical and\\or mental exertion
- ability of patients to understand assessment procedures
You may not qualify if:
- intollerance of components of PanTrek
- participation in other trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of psychopharmacology Research center of mental health
Moscow, 115522, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Denis Burminskiy, MD, PhD
Mental health research center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- randomized asignment to placebo or IP group, double-blind design
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2022
First Posted
January 19, 2023
Study Start
January 9, 2023
Primary Completion
June 30, 2023
Study Completion
August 15, 2023
Last Updated
January 19, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share