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

Ketonic Pharm

Status: Not yet enrolling

Conditions: Patient Activation

Treatments: Dietary Supplement: PanTrek

Study type: Interventional

Funder types: Industry

Identifiers

NCT05689697

KetonicPharm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Patients will recieve matched by taste and color shot of 25 ml liquid in ampules

Treatment:

Dietary Supplement: PanTrek

Active treatment group

Experimental group

Description:

Patients will recieve shot of PanTrek 25 ml in anpules

Treatment:

Dietary Supplement: PanTrek