An interventional study of PanTrek in Patient Activation, sponsored by Ketonic Pharm LLC. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Ketonic Pharm LLC · Not applicable, Interventional, and Treatment
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.
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.
181 studies on the registry are indexed under Ketosis; 37 are open to participants now.
This study's planned enrollment of 88 is above the median of 25 across 144 interventional studies indexed under Ketosis.
Browse Ketosis studies →This is the only study on the registry with Ketonic Pharm LLC as lead sponsor.
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Exclusion Criteria:
Patients will recieve matched by taste and color shot of 25 ml liquid in ampules
Dietary Supplement: PanTrek
Patients will recieve shot of PanTrek 25 ml in anpules
Dietary Supplement: PanTrek
administration of exogenouse keton body
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.
Time frame: 15 days
indused ketosis
increase of ketons level from baseline to the end of the active treatment period of the study
Time frame: 15 days
Improvement in cognitive function
Difference in improvement in total scores of Montreal Cognitive Assessment (MoCA) between the treatment and placebo groups. Minimum value - 0, maximum value - 30 scores. The higher score means the better condition. The major difference means better outcome.
Time frame: 15 days
Improvement in visual attention and task switching.
Difference in improvement of total time of Trial Making Test (TMT) execution between the treatment and placebo groups. Normal value - 29 seconds for A part and 75 seconds for B part. The higher time means worse condition. Decrease of spended time means improvement or negative score, if the last result is substractes from the first result, means improvement.
Time frame: 15 days
Improvement in physical function
Difference in improvement in total scores of Daily Fatigue Investigation Scale (D-Fis) between the treatment and placebo groups. Minimum value - 0, maximum value - 32 scores. The higher score means the worse condition. The major difference means better outcome.
Time frame: 15 days
Safety profile in active and follow-up period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 on the first, 15th and 30th day.
Time frame: 30 days
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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