Background: The efficacy and safety of Andrographis paniculata (Burn.f.) Wall. ex Nees in the treatment of acute nonspecific upper respiratory tract infection (NS-URI) are still less clear due to the diversity of herbal preparations, dosages, and few large clinical trials. The authors aimed to investigate the therapeutic efficacy and safety of the crude extract from A. paniculata in acute NS-URI.

Materials and Methods: Patients aged 18 to 60 years old from government hospitals, with acute NS-URI were enrolled between January 2018 and August 2019. Drug allocation was randomized in block of six. The crude extract of A. paniculata was packed in capsules containing 20 mg of andrographolide andgiven thrice daily for four days. The placebo capsules were physically identical. Ten tablets of paracetamol were also given as symptom-rescue drug. They were followed at days 4 to 7, and 14 to 30.

Results: Eight hundred sixty-two patients were enrolled between January 2018 and August 2019. Thirty-three patients withdrew from the study, therefore, 829 patients remained in the final analysis. Four hundred nineteen cases (50.5%) received the crude extract, and 410 cases (49.5%) received the placebo. The demographic data, clinical manifestation, and laboratory findings at the enrollment were similar in both groups. At the first follow-up, the rates of severity of each and combined symptoms decreased similarly, and almost all patients felt much better or recovered on day 7. Paracetamol was used by 205 (48.9%) and 185 (45.1%) patients in the experimental and control groups, respectively, and about three tablets taken in each group. Patient satisfaction rates were also similar in both groups. Adverse effects were mild and self-limited in 18 (4.3%) and 9 (2.2%) patients in the experimental and control groups, respectively.

Conclusion: The therapeutic efficacy of the crude extract or active ingredient from A. paniculata for acute NS-URI was not confirmed. Both groups showed similarly mild and few adverse drug reactions.