Efficacy Evaluation of Shen Cao Gan Jiang Tang on Mild and Moderate COVID-19 Patients
Condition: COVID-19 Respiratory Infection; Herbal Medicine
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes
      COVID-19 (coronavirus disease 2019). Patients with COVID-19 may experience various clinical
      manifestations, from no symptoms to critical illness such as severe pneumonia and acute
      respiratory distress syndrome (ADRS). So far, there is no specific medication for COVID-19;
      hence, the current available treatments mostly aim at symptoms management and supportive
      care. From traditional medicine perspective, COVID-19 is classified as warm-disease (Wen-yi).
      The main points of treatment for COVID-19 in early stage based on traditional medicine
      perspective are strengthen the Protective Qi (Wei Qi - the body immune system), and restore
      the balance of Qi, which is vital biological energy to prevent the invasion of external
      pathogens, including the SARS-CoV-2 virus. The Shen Cao Gan Jiang Tang have including Gan Cao
      Gan Jiang Tang (GGT) with the addition of Ginseng. This formula is originated from Shang Han
      Lun (Treatise on Febrile Diseases Caused by Cold) by Zhang Zhong-jing, used to enhance the
      Protective Qi, treat the early stage of Febrile Diseases, This clinical trial aims to
      evaluate the efficacy of the Shen Cao Gan Jiang Tang on mild and moderate COVID-19 patients
    

Detailed description: 
      The main objectives of this clinical trial:

        1. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in
           addition to the standard of care on reducing duration and severity of symptoms compared
           with the standard of care in mild and moderate COVID-19 patients.

        2. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in
           addition to the standard of care on reducing the proportion of patients progressed to
           severe level compared with the standard of care in mild and moderate COVID-19 patients.

        3. Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in
           addition to the standard of care on reducing the time required to meet discharge
           standards compared with the standard of care in mild and moderate COVID-19 patients.

      This study is investigated by the following hypotheses: combining Shen Cao Gan Jiang Tang
      (Gan Cao Gan Jiang Tang with Ginseng) with the standard of care is effective in reducing the
      duration and severity of symptoms, reducing the proportion of patients progressed to severe
      level, and reducing the length of hospital stay on mild and moderate COVID-19 patients
    

Intervention name(s): Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)
Intervention type(s): Drug
Intervention description(s): Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days. In additional, patients also receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
Ingredients per formula (tang): 12 grams of honey-fried Radix Glycyrrhizae, 6 grams of Rhizoma Zingiberis (stir-baked), 6 grams of Panax Ginseng. The decoction of concentrated extract is packed into aluminum foil vacuum bag, 90ml per bag, 1 formula (tang) is equivalent to 2 bags. Patients use the decoction directly from the bag.
Daily dose: 1 bag per time, 2 times per day
Other intervention name(s): "Sâm Thảo Can khương thang (Cam thảo Can khương gia Nhân sâm)"
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, open-label, randomized controlled trial, we recruited patients with Covid-19 from five temporary for COVID-19 treatment in Ho Chi Minh City, Viet Nam.
The protocol was designed based on the Good Clinical Practice guidelines and The Declaration of Helsinki. Number of Participants have 150 mild COVID-19 patient and 150 moderate COVID-19 patient. In each group of mild or moderate patients, we plan to randomize in a 1:1 ratio. Subjects in the investigational group will receive Shen Cao Gan Jiang Tang in addition to the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline. Subjects in the controlled group will receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
Masking: None (Open Label)
Primary purpose: Treatment