Songling Xuemaikang Capsules for High Blood Pressure Together With Insomnia
Tests Songling Xuemaikang capsules against placebo in adults with hypertension and insomnia.
Plain-language title generated from the registry record
Registry title: Songling Xuemaikang in Hypertension and Insomnia Evaluation（SHINE）
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT07709442, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jing Liu
- Trial code
- NCT07709442
- Record updated
- 16 July 2026
- Original description
To evaluate the effect of Songling Xuemaikang Capsules on reducing 24-hour mean blood pressure in patients with hypertension accompanied by insomnia.Read full original descriptionShow less
Songling Xuemaikang Capsules in Hypertension and Insomnia Evaluation：a Randomized，Double-blind，Placebo-controlled Multicenter Study
To evaluate the effect of Songling Xuemaikang Capsules on reducing 24-hour mean blood pressure in patients with hypertension accompanied by insomnia.
Inclusion: 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.
Exclusion: 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; 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; Clinically significant laboratory abnormalities at screening: ALT > 1.5 × ULN, AST > 1.5 × ULN, or Serum creatinine ≥ 2.0 mg/dL; 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.