Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion

Not Applicable

Not yet recruiting

• Conditions: Patient Activation
• Interventions: Dietary Supplement: PanTrek

• Registration Number: NCT05689697
• Lead Sponsor: Ketonic Pharm LLC

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.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-23
• Study Start: 2023-01-09
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	PanTrek	Patients will recieve matched by taste and color shot of 25 ml liquid in ampules
Active treatment group	PanTrek	Patients will recieve shot of PanTrek 25 ml in anpules

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
indused ketosis	15 days	increase of ketons level from baseline to the end of the active treatment period of the study

Trial Locations

Locations (1)

Laboratory of psychopharmacology Research center of mental health; 🇷🇺 Moscow, Russian Federation