Efficacy of Kan Jang® in Patients with Mild COVID-19: Interim Analysis of a Randomized, Quadruple-Blind, Placebo-Controlled Trial

Abstract

Kan Jang®, the fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. & Maxim.) Maxim extracts, is a herbal medicinal product for relieving symptoms of upper respiratory tract infections. This study aimed to assess the efficacy of Kan Jang®/Nergecov® on duration and the relief of inflammatory symptoms in adults with mild COVID-19. 86 patients with laboratory-confirmed COVID-19 and mild symptoms for one to three days received supportive treatment (paracetamol) and six Kan Jang® (daily dose of andrographolides—90 mg) or placebo capsules a day for 14 consecutive days in this randomized, quadruple-blinded, placebo-controlled, two-parallel-group study. The primary efficacy outcomes were the decrease in the acute-phase duration and the severity of symptoms score (sore throat, runny nose, cough, headache, fatigue, loss of smell, taste, pain in muscles), an increase in cognitive functions, physical performance, quality of life, and decrease in IL-6, c-reactive protein, and D-dimer in blood. Kan Jang®/Nergecov® was effective in reducing the risk of progression to severe COVID-19, decreasing the disease progression rate by almost 2.5-fold compared to placebo. Absolute risk reduction by Kan Jang treatment is 14%, the relative risk reduction is 243.9%, and the number Needed to Treat is 7.14. Kan Jang®/Nergecov® reduces the duration of disease, virus clearance, and days of hospitalization and accelerates recovery of patients, relief of sore throat, muscle pain, runny nose, and normalization of body temperature. Kan Jang®/Nergecov® significantly relieves the severity of inflammatory symptoms such as sore throat, runny nose, and muscle pain, decreases pro-inflammatory cytokine IL-6 level in the blood, and increases patients’ physical performance (workout) compared to placebo. In this study, for the first time we demonstrate that Kan Jang®/Nergecov® is effective in treating mild COVID-19.

Andrographis paniculata Dosage Forms and Advances in Nanoparticulate Delivery Systems: An Overview

“…In these cases, we notice the amount of dose consumed by patients is about 3–4 tablets (85–500 mg) 3–4 times daily, especially if it is in the extract form. Hence, the daily intake is between 255 mg to 2000 mg, which may cause side effects [ 38 ].…”

Development and Optimization of Andrographis paniculata Extract-Loaded Self-Microemulsifying Drug Delivery System Using Experimental Design Model

“…Research from Sa-ngiamsuntorn et al, (2021) showed that AGP has a potent anti-SARS-CoV-2 activity with an IC 50 equivalent to the antiviral agent remdesivir [ 6 ]. A. paniculata also showed clinical efficacy, safety, and improved overall health in the acute phase of mild COVID-19 [ 7 ].…”

“…The highest amount of AGP that can possibly be found is 6% of the dried leaves weight and even lower in the stem (0.8–1.2%), while only 4% is contained in the whole plant [ 10 ]. Moreover, the recommended daily dose of A. paniculata crude or even the plant extract would require multiple tablets or capsules per dose to achieve an effective treatment (varied according to illness) due to the low amount of active compound by its weight and low bioavailability of AGP [ 7 , 11 , 12 ]. Commercially available dosage forms of A. paniculata crude or extract are mainly composed of solid dosage forms such as capsules and tablets; liquid dosage forms as in syrups, tinctures, and injectables; or semisolid dosage forms, e.g., creams and ointments [ 13 ].…”

Efficacy of Kan Jang® in Patients with Mild COVID-19: A Randomized, Quadruple-Blind, Placebo-Controlled Trial

“…& Maxim.) Maxim, known in Scandinavia under the proprietary name Kan Jang, was demonstrated to be effective in several clinical trials treating various viral upper-respiratory-tract infections (URTIs) [ 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 ]. It should be emphasized that Kan Jang and A. paniculata are two entirely different active substances of two different chemical compositions, with two unique pharmacological and toxicological profiles (biological signatures; Figure 2 ), which are different from their ingredients and purified compounds, e.g., andrographolides and eleutherosides [ 9 ].…”

“…Recently, we published the results of an interim analysis of this clinical trial in 86 patients recruited in Georgia during three waves of COVID-19 ( Figure 3 ) [ 18 ].…”