Randomized, double-blind, placebo-controlled, multicenter clinical study of Acupoint Application in the treatment of essential hypertension (grade 1)

Phase 1

• Conditions: Hypertension

• Registration Number: ITMCTR2200005697
• Lead Sponsor: Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the western diagnostic criteria for essential hypertension (Grade 1);

2. Aged between 18 and 75 (including 18 and 75);

3. Patients with essential hypertension (Grade 1) determined by hypertension blood pressure level should meet any one of the following three criteria:

(1) systolic blood pressure of 140 ~ 159 mmHg and/or diastolic blood pressure of 90 ~ 99mmHg, without taking any antihypertensive drugs in the past, no complications such as heart, brain and kidney;

(2) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still below the standard of 140-159/90-99mmHg after 3 months of lifestyle improvement or other forms of non-drug treatment;

(3) Those who have been clearly diagnosed as essential hypertension and whose blood pressure has not reached the standard after improving lifestyle or other forms of non-drug therapy and taking oral antihypertensive drugs for 3 months, and who refuse to take other western antihypertensive drugs;

4. The course of the patient clearly diagnosed as essential hypertension must be longer than 3 months;

5. Those who voluntarily participate in clinical observation and sign informed consent.

Exclusion Criteria

1. Various secondary hypertension (renal essential hypertension, nephrovascular hypertension, primary aldosteronism, pheochromocytoma, cortisolism, aortic coarctation, etc.);

2. Have accepted other new drug clinical experimenter in recent 3 months;

3. Patients with serious diabetic complications (diabetic retinopathy, diabetic nephropathy, diabetic peripheral neuropathy, diabetic foot, etc.) or patients with myocardial infarction or history of stroke within six months;

4. Pregnant or trying to get pregnant and breast-feeding women;

5. People who have been allergic to multiple drugs or have an allergic constitution;

6. Persons with combined mental illness, alcoholism and/or psychoactive substance substance abuse and dependence;

7. Simultaneous combination of the following organ damage or disease: Angina pectoris, heart failure, transient cerebral insufficiency, hypertensive encephalopathy, retinopathy (with or without optic papilledema), renal failure with plasma creatinine concentration above 2.0mg/dl, liver failure, aortic dissection or aortic aneurysm, Patients with obvious symptoms of arterial occlusive diseases, malignant tumors, diseases of hematopoietic system, gastrointestinal ulcer bleeding and bleeding tendency.

8. Patients with skin trauma, ulcers, skin infection or scar at the application site and those who are allergic to the patch.

Note: any one or more of the above items should be excluded and cannot be selected.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diastolic pressure;systolic pressure;

Secondary Outcome Measures

Name	Time	Method
renin;Fasting blood glucose;Quality of life scale score;Blood catecholamine;Angiotensin;Urinary catecholamine;blood fat;aldosterone;