Patient Activation
Conditions
Keywords
Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid
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.
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.
Interventions
DIETARY_SUPPLEMENTPanTrek
administration of exogenouse keton body
Sponsors
Ketonic Pharm LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
randomized asignment to placebo or IP group, double-blind design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* informed consent * diagnosis of astenia and/or decreased tolerance to physical and\\or mental exertion * ability of patients to understand assessment procedures
Exclusion criteria
* intollerance of components of PanTrek * participation in other trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| indused ketosis | 15 days | increase of ketons level from baseline to the end of the active treatment period of the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvement in cognitive function | 15 days | 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. |
| Improvement in visual attention and task switching. | 15 days | 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. |
| Improvement in physical function | 15 days | 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. |
| Safety profile in active and follow-up period | 30 days | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 on the first, 15th and 30th day. |
Countries
Russia
Contacts
Primary ContactDenis Burminskiy, MD, PhD
Backup ContactAllan Beniashvili, MD, PhD
Outcome results
None listed