Evaluation of curative effect of traditional Chinese medicine on chronic kidney disease and dialysis patients with severe new coronavirus infection: a multicenter, prospective, open label, blank control, blind evaluation and randomized controlled trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Control group:Basic western medicine treatment;test team:Basic western medicine treatment+traditional Chinese medicine intervention treatment(Huashi Paidu Yishen recipe/Hushen Jiedu recipe); CONDITION: COVID‐19 diseases PRIMARY OUTCOME: Time interval and proportion from random to clinical improvement (clinical symptoms include respiratory rate, skin oxygen, oxygenation index PaO2/FiO2, CT imaging changes, subject to the improvement time of the last index);Improvement time of chest CT and the proportion of patients; SECONDARY OUTCOME: The proportion of subjects whose disease progressed to critical condition during the observation period of 28 days after randomization.;All‐cause mortality of the subjects in the observation period of 28 days after randomization;Time interval from random to discharge;The proportion of patients whose TCM syndrome score decreased by =30% during the observation period of 14 days after randomization;Inflammation index;Tcm syndrome curative effect score; INCLUSION CRITERIA: 1. The diagnosis of western medicine conforms to novel coronavirus's criteria for diagnosis and severe typing of infection, CKD's criteria for diagnosis and staging CKD stage 4‐5 (GFR < 30ml/min/1.73m2) and dialysis patients. 2. TCM syndrome differentiation conforms to the syndrome of epidemic toxin closing lung or yang deficiency and epidemic toxin invading lung. 3. The age is between 18 and 85; 4. The subjects agreed and signed the informed consent form.
Epistemonikos ID: db04a1e09cf912e119848703d72ae9e0cbd62477
First added on: Oct 02, 2023