Dataset Information

Early intervention with Kan Jang® to treat upper-respiratory tract infections: A randomized, quadruple-blind study

ABSTRACT:

Background and aim

Andrographis paniculata and Eleutherococcus senticosus preparations and their fixed combination, called Kan Jang®, are traditionally used for relieving symptoms of upper-respiratory tract infections (URTIs). This study aimed to assess the efficacy of early intervention with Kan Jang® on the relief and duration of inflammatory symptoms during the acute phase of the disease.

Experimental procedure

A total of 179 patients with URTI symptoms received six Kan Jang® (daily dose of andrographolides: 60 mg) or placebo capsules a day for five consecutive days in this randomized, quadruple-blinded, placebo-controlled, two-parallel-group phase II study. The primary efficacy outcomes were the decrease in the acute-phase duration and the mean URTI symptoms score (sore throat, runny nose, nasal congestion, hoarseness, cough, headache, and fatigue).

Results

Early intervention with Kan Jang® significantly increased the recovery rate and reduced the number of sick leave days by >21% (0.64/day) relative to that observed in the placebo group (2.38 vs. 3.02 days, p = 0.0053). Kan Jang® significantly alleviated all URTI symptoms starting from the second day of treatment. A superior anti-inflammatory effect of Kan Jang® to that of placebo was also observed on the white blood cell count (p = 0.007) and erythrocyte sedimentation rate (p = 0.0258). Treatment with Kan Jang® was tolerated well.

Conclusion

This study demonstrates that early intervention with Kan Jang® capsules reduces the recovery duration of patients by 21% and significantly relieves the severity of typical URTI symptoms. Graphical abstract Image 1 Highlights Early intervention with Kan Jang® capsules, a fixed combination of Andrographis paniculata and Eleutherococcus senticosus extracts:• Significantly increased patients' recovery rate on days 2, 3, and 4 compared to placebo.• Increased the number of recovered patients by 24% on day 3 compared to placebo control.• Reduced the time to major improvement, defined as the number of sick leave days at home.• Reduced the overall recovery duration time of patients by 21%.• Significantly relieved typical URTI symptoms severity.

SUBMITTER: Narimanyan M

PROVIDER: S-EPMC8572720 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and aim. This study aimed to assess the efficacy of the treatment of Kan Jang®, a fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. & Maxim.) Maxim extracts in patients with mild symptoms of COVID-19. Methods. One hundred and forty patients received six capsules of Kan Jang® (n = 68, daily dose of andrographolides-90 mg) or placebo (n = 72) and supportive treatment (paracetamol) for 14 consecutive days in a randomized, quadruple-blinded, placebo-controlled, two-parallel-group design. The efficacy outcomes were the rate of cases turning to severe, the detection rate of coronavirus SARS-CoV-2 over the time of treatment, the duration, and the severity of symptoms (sore throat, runny nose, cough, headache, fatigue, loss of smell, taste, pain in muscles) in the acute phase of the disease. Other efficacy measures included improving cognitive and physical performance, quality of life, and the levels of inflammatory blood markers-interleukin 6 (IL-6), C-reactive protein, and D-dimer. Results. Kan Jang® significantly (p < 0.05) reduced the rate of cases turning to severe (5.36%) compared to the placebo (17.86%) and decreased the detection rate of SARS-CoV-2 virus over the time of the treatment. The statistical difference in the rates of patients with clinical deterioration in the Kan Jang treatment and placebo control groups was significant (p = 0.0176) both in the 112 patients in the included-per-protocol (IPP) analysis and in the 140 patients in the intended-to-treat (ITT) analysis (p = 0.0236); the absolute risk reduction in cases thanks to the Kan Jang treatment was 12.5%, and the number we needed to treat with Kan Jang was 8. The patient's recovery time (number of sick days at the home/clinic) was shorter in the Kan Jang group compared with the placebo group. The rate of attenuation of inflammatory symptoms in the Kan Jang® group was significantly higher, decreasing the severity of cough, sore throat/pain, runny nose, and muscle soreness compared with the placebo group. Kan Jang® significantly decreased the Wisconsin Upper Respiratory Symptoms scores compared to the placebo in the sample size of 140 patients. However, the relief of fatigue and headache and the decrease in IL-6 in the blood were observed only in a subset of 86 patients infected during the second three waves of the pandemic. Kan Jang® significantly increased physical activity and workout; however, it did not affect cognitive functions (attention and memory), quality of life score, inflammatory marker D-dimer, and C-reactive protein compared with the placebo group. Conclusions. Overall, the results of this study suggest that Kan Jang® is effective in treating mild and moderate COVID-19 irrespective of the SARS-CoV-2 variant of infection.