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Efficacy of Adaptogens in Patients With Long COVID-19

NCT04795557 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-28

No results posted yet for this study

Summary

The aim of this clinical trial of a fixed combination of standardized extracts from Rhodiola rosea roots, Schisandra chinensis berry and Eleutherococcus senticosus root (ADAPT-232) in COVID-19 patients is to demonstrate possible efficacy of adjuvant treatment with ADAPT-232 in decreasing the duration of the convalescence, alleviation of fatigue, headache, attention deficit, difficult and rapid respiration, depression, anxiety and other symptoms of Long COVID-19 during rehabilitation period.

Conditions

  • Covid19

Interventions

DIETARY_SUPPLEMENT

ADAPT-232 oral solution

One ml of ADAPT 232/CHISAN oral solution contains: Fructus Schizandrae native extract DERnative 2-4:1, (extraction solvent . 95% ethanol) - 10 mg corresponding to 20-40 mg dried fruit; Radix Eleutherococci native extract DERnative 17-30:1 (extraction solvent - 70% ethanol) - 2.6 mg corresponding to 44-78 mg dried rhizomes, and Radix Rhodiolae native extract DERnative 2-5:1 (extraction solvent - 70% ethanol) - 3 mg corresponding to 6-30 mg dried rhizomes. Excipients

OTHER

Placebo oral solution

Excipients

Sponsors & Collaborators

  • National Family Medicine Training Centre, Georgia

    collaborator UNKNOWN

  • Tbilisi State Medical University

    collaborator OTHER

  • Phytomed AB

    collaborator OTHER

  • Swedish Herbal Institute AB

    lead INDUSTRY

Principal Investigators

  • Irina Karosanidze, PhD, MD · Director of National Family Medicine Training Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-11-11
Completion
2021-12-26

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795557 on ClinicalTrials.gov