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Clinical Trials in China / NCT07709442
Starting soon Not applicable

Songling Xuemaikang in Hypertension and Insomnia Evaluation(SHINE)

NCT07709442 · tracked via the Priya Life Science China tracker
Sponsor
Jing Liu
Phase
Not applicable
Started
2026-06-30
Last updated
2026-07-16

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

Songling Xuemaikang CapsuleSongling Xuemaikang Capsule Simulant

Songling Xuemaikang Capsule: 3 capsules each time, 3 times a day, for 12 consecutive weeks.

Songling Xuemaikang Capsule Simulant: Songling Xuemaikang Capsule Simulant, 3 capsules each time, 3 times a day, for 12 consecutive weeks.

Study summary

To evaluate the effect of Songling Xuemaikang Capsules on reducing 24-hour mean blood pressure in patients with hypertension accompanied by insomnia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-79 years (inclusive), male or female; 2. 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; 3. Insomnia Serverity Index (ISI) score ≥ 8, symptoms occur for at least 3 nights per week and have persisted for no less than 3 months; 4. No sedative-hypnotic drugs have been taken within the preceding one month; 5. Is able to complete scale assessments independently; 6. Is willing and able to comply with all examinations and observations specified in the protocol; Has provided written informed consent. Exclusion Criteria: 1. Severe hypertension (mean SBP ≥ 180 mmHg and/or mean DBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc. 2. Suspected secondary hypertension (renal parenchymal hypertension, renovascular hypertension, obstructive sleep apnea, primary aldosteronism or other endocrine hypertension, drug-induced hypertension, monogenic hypertension, etc.); 3. Clinically significant laboratory abnormalities at screening: ALT \> 1.5 × ULN, AST \> 1.5 × ULN, or Serum creatinine ≥ 2.0 mg/dL; 4. Chronic gastrointestinal disorders accompanied by frequent abdominal pain or diarrhea, or history of gastrointestinal surgery that may impair drug absorption; 5. A history of allergic diathesis or hypersensitivity to any component of the investigational product; 6. 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; 7. Clinically severe and unstable hepatic, renal, hematologic disease, malignant tumor, or unilateral/bilateral renal artery stenosis; 8. Documented psychiatric disorder, or GAD-7 score ≥ 10 or PHQ-9 score ≥ 10; 9. Insomnia due to hyperthyroidism, restless legs syndrome, narcolepsy, sleep-related movement disorders, etc.; 10. Insomnia due to neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, epilepsy, etc.); 11. Acute stroke; 12. Confirmed diagnosis of OSA or STOP-BANG score ≥ 5; 13. Night shift or rotating shift workers; 14. Suspected or confirmed alcohol or drug abuse/dependence; 15. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07709442 on ClinicalTrials.gov ↗ ← All trials in China