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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05689697
Other study ID # KetonicPharm
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date August 15, 2023

Study information

Verified date December 2022
Source Ketonic Pharm LLC
Contact Denis Burminskiy, MD, PhD
Phone +79262344633
Email desbur@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PanTrek
administration of exogenouse keton body

Locations

Country Name City State
Russian Federation Laboratory of psychopharmacology Research center of mental health Moscow

Sponsors (1)

Lead Sponsor Collaborator
Ketonic Pharm LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

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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