Pneumonia Clinical Trial
Official title:
Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases
The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.
The retrospective case study has been finished at the National clinical research base of
traditional Chinese medicine for major disease pediatric pneumonia, and the research center
organized the field training of prospective-study to coordinated units. Based on the primary
statistical outcomes of retrospective case study and the discussion around prospective-study
during the training, investigators found it difficult to include simplex viral infection,
therefore, investigators revised the inclusion criteria and treatment protocol of the
pragmatic randomized controlled trial.
The block randomization is used in this trial. Random numbers are generated by SPSS
software. Statistical analysis staff and those who perform the follow-up are blinded. Sample
size calculation was performed, which was 369, and considering drop-out or withdrawal,
investigators plan to enroll 450 patients (300 in experimental group, 150 in control).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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