Efficacy, Safety and Mechanism of Modified Xianyaoyin in Patients with Mild to Moderate Hypertriglyceridemia: A Study Protocol for a Multicenter and Randomized Controlled Trial

INTERVENTION: 01020000 CONTROL:treated with placebo, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 12 weeks.;TEST:treated with modified Xianyaoyin granules, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 12 weeks.;TEST:lifestyle;CONTROL:lifestyle; CONDITION: Hypertriglyceridemia PRIMARY OUTCOME: fasting triglycerides; SECONDARY OUTCOME: fasting low‐density lipoprotein cholesterol;fasting high‐density lipoprotein cholesterol;body mass index;fasting total cholesterol;TCM Syndromes Scale;lipoprotein a;degree of fatty liver; INCLUSION CRITERIA: (1)Aged from 18 to 65 years old. (2)1.7=TG<5.7mmol/l, LDL‐C<4.9mmol/l, TC<7.2mmol/l. (3)Meet the diagnostic criteria of TCM syndrome of phlegm and blood stasis based on the Guiding Principles for Clinical Research of New Traditional Chinese Medicine (2002). Main symptoms: obesity, heaviness of the head, vomiting of phlegm and saliva, numbness and lassitude of limbs, and chest distress. Secondary symptoms: palpitation, insomnia, anorexia and relentlessness. Tongue & pulse: enlarged tongue with slippery/slimy coating, ecchymosis and petechia. Wiry or rough pulse. Patients with 1 main symptom / 2 secondary symptoms and above tongue and pulse can be diagnosed as phlegm and blood stasis. (4)Inform consent.