Investigate the Clinical Study of 'Tongdu Tiaoshen' Acupuncture in the Intervention of Hypertension with Insomnia Based on PPSG
- Conditions
- Hypertension with insomnia
- Registration Number
- ITMCTR2200005911
- Lead Sponsor
- Jiangsu Province Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. No gender restriction, ages 18-70.
2. Meeting the ICSD-3 diagnostic criteria for insomnia;
3. 8=ISI score=22
4. Patients who meet the diagnostic criteria of essential hypertension, and the cardiovascular risk stratification is low to medium risk, the blood pressure control is relatively stable, and the types of hypertension drugs taken are CCB+ACEI/ARB, but no more than two types;
5. Voluntarily participate in this trial and sign the informed consent form, and the process of obtaining the informed consent form should comply with GCP regulations.
1. Patients with serious physical diseases;
2. HAMA score=2 or HAMD score=18
3. Caffeinealcohol or psychotropic substances dependence;
4. Other types of sleep disorders such as sleep apnea and restless legs syndrome;
5. Night shift workers
6. Stop insomnia-related interventions (including traditional Chinese medicine, acupuncture, massage, and western medicine)=2 weeks;
7. Change of antihypertensive plan within the last 1 month;
8. Pregnant and lactating women;
9. At the same time participate in other research groups.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method