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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Herbal Institute AB
• Collaborators: Phytomed AB; Tbilisi State Medical University

Criteria

Inclusion Criteria:

• Laboratory confirmed (SARS-Cov-2 PCR-positive test) mild COVID-19 infection (in the last three days),

• COVID-19 patient in stable, moderate condition (i.e., not requiring Intensive Care Unit (ICU) admission).

• Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).

• Able to take medication alone

• Able to give informed consent.

Exclusion Criteria:

• Pulmonary diseases

• Chronic pulmonary diseases

• Chronic rhinosinusitis

• Patient admitted already under invasive mechanical ventilation;

• The patient admitted with the severe acute respiratory syndrome and diagnosed with an etiologic agent other than Covid 19;

• Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;

• Tube feeding or parenteral nutrition.

• Respiratory decompensation requiring mechanical ventilation.

• Uncontrolled diabetes type 2.

• Hypertension stage 3,

• Autoimmune disease.

• Pregnant or lactating women.

• Patients are taking antibiotics for a reason other than COVID-19 at enrollment.

• Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);

• Patients treated with chemo-radio-corticosteroid therapy in the last six months.

• Patients with active cancer.

• Taking immunosuppressive drugs (e.g., anti-rejection treatment after organ transplant);

• Already participating in another clinical trial;

• Has any other condition that would prevent safe participation in the study.