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

NCT ID: NCT05689697

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2023-08-15

Brief Summary

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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

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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.

Conditions

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Patient Activation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
randomized asignment to placebo or IP group, double-blind design

Study Groups

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Placebo group

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

Group Type PLACEBO_COMPARATOR

PanTrek

Intervention Type DIETARY_SUPPLEMENT

administration of exogenouse keton body

Active treatment group

Patients will recieve shot of PanTrek 25 ml in anpules

Group Type EXPERIMENTAL

PanTrek

Intervention Type DIETARY_SUPPLEMENT

administration of exogenouse keton body

Interventions

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PanTrek

administration of exogenouse keton body

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ketonic Pharm LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis Burminskiy, MD, PhD

Role: STUDY_DIRECTOR

Mental health research center

Locations

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Laboratory of psychopharmacology Research center of mental health

Moscow, , Russia

Site Status

Countries

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Russia

Central Contacts

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Denis Burminskiy, MD, PhD

Role: CONTACT

+79262344633

Allan Beniashvili, MD, PhD

Role: CONTACT

+79859259676

Facility Contacts

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Denis Burminsiy, MD, PhD

Role: primary

+79262344633

Allan Beniashvili, MD, PhD

Role: backup

+79859259676

Other Identifiers

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KetonicPharm

Identifier Type: -

Identifier Source: org_study_id

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