OBJECTIVES: Phlegm syndrome is frequent in TCM clinical trials. Although the diagnosis of phlegm syndrome has been clear, it is difficult to evaluate the clinical efficacy of TCM on it properly. Therefore, a patients reported scale is needed. This study aims to establish the theoretical framework for A Patient Reported Syndrome Scale: Phlegm Syndrome (PRS-PS). METHODS: The study was conducted in three steps. Firstly, the concept and manifestation of phlegm syndrome were determined by literature research. Secondly, patients diagnosed with phlegm syndrome and with different diseases were included in an in-depth interview to collect information. Finally, we invited 8 experts to form a focus group into discussionfor the theoretical framework. RESULTS: Through literature review, phlegm syndrome is characterized by phlegm stasis in the body and mainly showed copius sputum production, poor appetite, abdominal distension, greasy mouth, heaviness in the body, sticky greasy coating and slippery pulse. Secondly, a total of 32 eligible patients (average age: 63, 5 males) covering variety of diseasesparticipated in the interview. Patients' concerning concentrated in nine dimensions, namely poor appetite, abdominal distension, greasy mouth, expectoration, heaviness in the body, daytime somnolence, dizziness, sticky stool and sticky greasy coating. Finally, nine dimensions were clasified into 11 items related to patients’ quality of life, and only the dimensions of poor appetite (poor appetite and tastelessness) and abdominal distension (bloatingand being afraid of eating because of abdominal distention) had two items and the others had only one, expectively. Patients didn’t pay much attention to a lump in pharynx sensation, inadaptability to rainy and wet weather and snoring, which were a little lack of universality. CONCLUSIONS: The framework for PRS-PS were preliminarily established and nine dimensions including 11 items were covered.