Patient Activation Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | August 15, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Laboratory of psychopharmacology Research center of mental health | Moscow |
Lead Sponsor | Collaborator |
---|---|
Ketonic Pharm LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 15 days | |
Other | 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. | 15 days | |
Other | 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. | 15 days | |
Other | 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. | 30 days | |
Primary | 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 | indused ketosis | increase of ketons level from baseline to the end of the active treatment period of the study | 15 days |
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