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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild (grade 1) essential hypertension who also have insomnia. It tests Songling Xuemaikang Capsules against a placebo on 24-hour mean blood pressure.
- Age
- 18 to 79 years
- Sex
- Men and women can join.
- Disease stage
- Essential hypertension, grade 1. Insomnia Severity Index (ISI) score of 8 or more, on at least 3 nights a week, for at least 3 months.
- Earlier treatment
- Either no blood pressure drugs in the past 2 weeks, or stable treatment with one standard-dose blood pressure drug for at least 4 weeks with blood pressure 140-159/90-99 mmHg. No sleeping pills (sedative-hypnotics) in the past month.
Main reasons for not taking part
- Severe or malignant hypertension, or blood pressure of 180/110 mmHg or higher
- Suspected secondary hypertension, such as kidney, hormone or sleep apnea causes
- Liver or kidney test results outside the limits set in the record
- Pregnant, breastfeeding or planning pregnancy
- Psychiatric disorder, or insomnia caused by another illness, or night or rotating shift work
Read by machine on 12 November 2026.
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, ChinaContact: Jing Liu, MDNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.