Songling Xuemaikang in Hypertension and Insomnia Evaluation（SHINE）

Prior treatment

• A history of allergic diathesis or hypersensitivity to any component of the investigational product;
• Suspected or confirmed alcohol or drug abuse/dependence;
• Participation in another clinical trial within 3 months prior to screening; Any other condition deemed by the investigator to render the subject unsuitable for the trial.

Other illness

• Severe hypertension (mean SBP ≥ 180 mmHg and/or mean DBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.
• Suspected secondary hypertension (renal parenchymal hypertension, renovascular hypertension, obstructive sleep apnea, primary aldosteronism or other endocrine hypertension, drug-induced hypertension, monogenic hypertension, etc.);
• Chronic gastrointestinal disorders accompanied by frequent abdominal pain or diarrhea, or history of gastrointestinal surgery that may impair drug absorption;
• Clinically severe and unstable hepatic, renal, hematologic disease, malignant tumor, or unilateral/bilateral renal artery stenosis;
• Documented psychiatric disorder, or GAD-7 score ≥ 10 or PHQ-9 score ≥ 10;
• Insomnia due to hyperthyroidism, restless legs syndrome, narcolepsy, sleep-related movement disorders, etc.;
• Insomnia due to neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, epilepsy, etc.);
• Acute stroke;

Lab values

• Clinically significant laboratory abnormalities at screening: ALT \> 1.5 × ULN, AST \> 1.5 × ULN, or Serum creatinine ≥ 2.0 mg/dL;

Other

• Pregnant females，or those with a positive pregnancy test at screening, women planning pregnancy during the study, lactating women, or fertile women without adequate contraception protection;
• Confirmed diagnosis of OSA or STOP-BANG score ≥ 5;
• Night shift or rotating shift workers;

• Age 18-79 years (inclusive), male or female;
• Meet diagnostic criteria for essential hypertension, and satisfy one of the following conditions:
  • Grade 1 hypertension with no antihypertensive drugs in the past 2 weeks; Receiving stable treatment with one standard-dose chemical antihypertensive agent for at least 4 weeks, with blood pressure（BP）140-159/90-99 mmHg, and is willing to maintain the treatment regimen without adjustment;
• Insomnia Serverity Index (ISI) score ≥ 8, symptoms occur for at least 3 nights per week and have persisted for no less than 3 months;
• No sedative-hypnotic drugs have been taken within the preceding one month;
• Is able to complete scale assessments independently;
• Is willing and able to comply with all examinations and observations specified in the protocol; Has provided written informed consent.