Songling Xuemaikang in Hypertension and Insomnia Evaluation（SHINE）

NCT07709442 | Not Yet Recruiting

• 1 other identifier: SLXMKJN-20260121
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Insomnia; Hypertension; Songling Xuemaikang Capsules

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour mean systolic blood pressure at Week 12.

  From baseline to Week 12.

Secondary Outcomes (24)

• Blood pressure-related parameters

  From baseline to Weeks 4, 8, and 12.

• Other detection parameters

  From baseline to Week 12.

• Other detection parameters

  From baseline to Week 12

• Scale assessments

  From baseline to Weeks 4, 8, and 12.

• Scale assessments

  From baseline to Weeks 4, 8, and 12.

Study Arms (2)

Songling Xuemaikang Capsule

EXPERIMENTAL

Drug: Songling Xuemaikang Capsule

Songling Xuemaikang Capsule Simulant

PLACEBO COMPARATOR

Drug: Songling Xuemaikang Capsule Simulant

Interventions

Songling Xuemaikang Capsule DRUG

3 capsules each time, 3 times a day, for 12 consecutive weeks.

Songling Xuemaikang Capsule

Songling Xuemaikang Capsule Simulant DRUG

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

Songling Xuemaikang Capsule Simulant

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.);
• Clinically significant laboratory abnormalities at screening: ALT \> 1.5 × ULN, AST \> 1.5 × ULN, or Serum creatinine ≥ 2.0 mg/dL;
• Chronic gastrointestinal disorders accompanied by frequent abdominal pain or diarrhea, or history of gastrointestinal surgery that may impair drug absorption;
• A history of allergic diathesis or hypersensitivity to any component of the investigational product;
• 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;
• 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;
• Confirmed diagnosis of OSA or STOP-BANG score ≥ 5;
• Night shift or rotating shift workers;
• 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.

Sponsors & Collaborators

• Jing Liu: lead
• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders

Interventions

songling xuemaikang

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jing Liu, MD

CONTACT

+86 10 88325457; heartcenter@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Hypertension

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 16, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)