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Assessment of Efficacy of KAN-JANG® in Mild COVID-19

NCT04847518 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-09-22

No results posted yet for this study

Summary

The complexity of COVID-19 suggests a potential need for a range of therapies, including antiviral agents, immunostimulants, immunosuppressants, adaptogens, and anticoagulants. In this context, implementation of polyvalency drugs, which exhibit a wide range of biological activities and multitarget effects that is common for herbal medicines and specifically for Kan Jang, the fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. \& Maxim.) Maxim which are known to exhibit antiviral, immunomodulatory, and anti-inflammatory effects and clinical efficacy in the respiratory tract of patients with infectious diseases. The purpose of this study is to provide scientific evidence on the effectiveness of Kan Jang for the treatment of mild COVID-19. We hypothesize that Kan Jang will have superior efficacy in amelioration COVID symptoms compared to placebo with a comparable safety profile to placebo. We hypothesize that Kan Jang will increase patients' recovery rate and decrease the duration of illness.

The objective of the study is to assess the efficacy and tolerability of adjuvant treatment with Kan Jang for alleviating the severity of inflammatory symptoms (headache, loss of smell, gustatory dysfunction, rhinorrhea, nasal congestions, cough, sore throat, asthenia, myalgia, and fever) and shortening of their duration in mild COVID-19 patients.

Conditions

  • Covid19

Interventions

DRUG

Kan Jang capsules

One capsule contains a fixed combination of proprietary * Andrographis paniculata Nees. herb, native extract, DER native 4,5-8,0 :1 260 mg (Diterpene lactones andrographolide and 14-deoxy, 11,12- didehydroadnrograholide) 15-20 mg * Eleutherococcus senticosus (Rupr. et Maxim) Harms, root, native extract DER native 17-30:1 : 11.4 mg and other inactive excipients (Polycristalline cellulose, Magnesium stearate).

OTHER

Placebo capsules

Inactive excipients

Sponsors & Collaborators

  • Tbilisi State Medical University

    collaborator OTHER

  • Phytomed AB

    collaborator OTHER

  • Swedish Herbal Institute AB

    lead INDUSTRY

Principal Investigators

  • Levan Ratiani, PhD, MD · The First University Clinic of Tbilisi State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2022-01-31
Completion
2022-03-31

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 NCT04847518 on ClinicalTrials.gov