Back to resultsInduced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
Primary Purpose
Patient Activation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
PanTrek
Sponsored by
About this trial
This is an interventional treatment trial for Patient Activation focused on measuring Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid
Eligibility Criteria
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
Sites / Locations
- Laboratory of psychopharmacology Research center of mental health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Active treatment group
Arm Description
Patients will recieve matched by taste and color shot of 25 ml liquid in ampules
Patients will recieve shot of PanTrek 25 ml in anpules
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
indused ketosis
increase of ketons level from baseline to the end of the active treatment period of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05689697
Brief Title
Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ketonic Pharm LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Activation
Keywords
Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
randomized asignment to placebo or IP group, double-blind design
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients will recieve matched by taste and color shot of 25 ml liquid in ampules
Arm Title
Active treatment group
Arm Type
Experimental
Arm Description
Patients will recieve shot of PanTrek 25 ml in anpules
Intervention Type
Dietary Supplement
Intervention Name(s)
PanTrek
Intervention Description
administration of exogenouse keton body
Primary Outcome Measure Information:
Title
Primary outcome
Description
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
Secondary Outcome Measure Information:
Title
indused ketosis
Description
increase of ketons level from baseline to the end of the active treatment period of the study
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
Improvement in cognitive function
Description
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
Title
Improvement in visual attention and task switching.
Description
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
Title
Improvement in physical function
Description
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
Title
Safety profile in active and follow-up period
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Burminskiy, MD, PhD
Phone
+79262344633
Email
desbur@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Beniashvili, MD, PhD
Phone
+79859259676
Email
beniashvilia@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Burminskiy, MD, PhD
Organizational Affiliation
Mental health research center
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory of psychopharmacology Research center of mental health
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Burminsiy, MD, PhD
Phone
+79262344633
Email
desbur@gmail.com
First Name & Middle Initial & Last Name & Degree
Allan Beniashvili, MD, PhD
Phone
+79859259676
Email
beniashvilia@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
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