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Efficacy and Visualization Analysis of Modified Zhejue Qiwei Decoction for Hypertension with Insomnia in Patients with Qi-Deficiency and Phlegm-Dampness Constitution Based on the Theory of Preventive Treatment of Disease

Efficacy and Visualization Analysis of Modified Zhejue Qiwei Decoction for Hypertension with Insomnia in Patients with Qi-Deficiency and Phlegm-Dampness Constitution Based on the Theory of Preventive Treatment of Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000649
Enrollment
Unknown
Registered
2026-03-20
Start date
2024-12-13
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension combined with insomnia

Interventions

treatment group:basic treatment combined with the modified Zhejue Qiwei decoction
control group:basic treatment

Sponsors

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with primary hypertension by relevant examinations, with stable blood pressure control and no need for adjustment of antihypertensive medication type or dosage in the recent period; 2.Meeting the diagnostic criteria for short-term insomnia; 3.Meeting the diagnostic criteria for Qi-deficiency and phlegm-dampness constitution; 4.Aged 18–65 years;5.Voluntary participation in the clinical trial with informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Sleep disorders caused by other factors such as fever, cough, dyspnea, or pain; 3. Individuals presenting with three or more constitution types and not predominantly characterized by Qi-deficiency and phlegm-dampness constitution; 4. Patients complicated with severe primary diseases of the heart, brain, liver, or hematopoietic system; 5. Patients with severe psychiatric disorders; 6. Conditions that may affect examination results, such as skin diseases of the head and face, chest, or abdomen; 7. Alcohol abuse or a history of drug abuse or dependence; 8. Pregnant or lactating womenn; 9. BMI=30 kg/m².

Design outcomes

Primary

MeasureTime frame
Infrared Thermography;Reduction rate of the Pittsburgh Sleep Quality Index (PSQI);Antihypertensive efficacy;

Secondary

MeasureTime frame
Changes in constitution transformation scores;Psychological assessment;Quality of life assessment;Adverse reactions;

Countries

China

Contacts

Public ContactLIANG Li-chang

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

173378750@qq.com13242828127

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026