Herbal capsule aims to tackle both high blood pressure and poor sleep
NCT ID NCT07709442
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study investigates whether Songling Xuemaikang capsules, a traditional Chinese herbal formula, can help people with both high blood pressure (hypertension) and insomnia. About 260 adults aged 18–79 with mild hypertension and sleep difficulties will take either the herbal capsules or a placebo three times daily for 12 weeks. Researchers will measure changes in 24-hour blood pressure and sleep quality to see if the treatment offers dual benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Songling Xuemaikang capsules (a traditional Chinese medicine herbal formula)
- What this could lead to
- If successful, this could offer a new option for managing high blood pressure while also improving sleep quality.
- What could go wrong
- This is an early-stage study with a modest number of participants. The herbal formula may not prove more effective than placebo, and its long-term safety is not yet established.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Peking University People's Hospital
Beijing, China
Contact Email: •••••@•••••
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