Hypertension
Conditions
Interventions
Mild hypertension: Experimental group.:Dendrobium officinale chewable tablets (4 tablets/time, 3 times/day). Continuous oral administration for 12 weeks,
Mild Hypertension: Positive Control Group.:Losartan (50mg per dose, once a day). Continuous oral administration for 12 weeks.
Moderate Hypertension: Test Group. : Losartan (25mg per dose, once a day) and Amlodipine (2.5mg per dose, once a day), combined with Dendrobium officinale chewable tablets (4 tablets per dose, 3 times
Moderate Hypertension: Positive Control Group. :Losartan (50mg per dose, once a day) and Amlodipine (5mg per dose, once a day). Continuous oral administration for 12 weeks
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Mild hypertension: 1. The 14-day run-in period (discontinuation of all antihypertensive traditional Chinese medicines or Western medicines) ends (during the run-in period, participants must measure their home blood pressure on average 1-2 times daily, with at least 2 home blood pressure measurements in the last 4 days; at least 7 blood pressure measurements must be completed after the end of the run-in period), and the average blood pressure meets the diagnostic criteria for primary hypertension as per standard office blood pressure measurements (referring to the "Chinese Guidelines for the Prevention and Treatment of Hypertension" and the "Guidelines for the Diagnosis and Treatment of Hypertension in Primary Care"); 2. Hypertension is classified as stage 1 (office blood pressure: 140mmHg = average seated systolic blood pressure (msSBP) = 159mmHg, and/or 90mmHg = average seated diastolic blood pressure (msDBP) = 99mmHg), individuals are at low or medium risk stratification (referring to the "Chinese Guidelines for the Prevention and Treatment of Hypertension" and those with dynamic 24-hour blood pressure = 140/90mmHg) (no other cardiovascular risk factors, such as vascular plaques, vascular sclerosis, hyperlipidaemia, hyperglycaemia, high weight, high uric acid, or significant smoking or drinking habits, should be present); 3. Untreated patients (defined as those recently diagnosed with primary hypertension or those with a history of hypertension who have not taken any antihypertensive medications for at least 2 weeks prior to screening); 4. Traditional Chinese medicine syndrome diagnosed as Yin deficiency and Yang excess; 5. Aged between 18 and 65 years, regardless of gender; 6. Willing to participate in the trial and sign an informed consent form. Moderate hypertension: 1. The 14-day induction phase (taking half the dosage of two antihypertensive medications: 25mg of Losartan and 2.5mg of Amlodipine, while stopping all other antihypertensive Chinese or Western medications) ends (during the induction phase, participants are required to measure their home blood pressure an average of 1-2 times daily, with at least 2 measurements in the last 4 days; after the induction phase, at least 7 blood pressure measurements must be completed), with average blood pressure conforming to the diagnostic criteria for primary hypertension based on standard in-office blood pressure measurements (refer to the "Chinese Hypertension Prevention and Treatment Guidelines" and the "Guidelines for Hypertension Diagnosis and Treatment at the Community Level"); 2. The grading of hypertension remains within the stage 1 blood pressure range (in-office blood pressure: 140mmHg=average sitting systolic blood pressure (msSBP)=159mmHg, and/or 90mmHg=average sitting diastolic blood pressure (msDBP)=99mmHg), with a risk stratification of low or moderate risk (refer to the "Chinese Hypertension Prevention and Treatment Guidelines" and those with dynamic 24-hour blood pressure =140/90mmHg) (excluding other cardiovascular risk factors, such as vascular plaques, vascular sclerosis, dyslipidaemia, hyperglycaemia, obesity, high uric acid, heavy smoking or drinking, etc.); 3. Untreated patients (referring to those with newly diagnosed primary hypertension or those with a history of hypertension who have not taken any antihypertensive medications for at least two weeks prior to screening); or those willing to switch to the drug regimen used during the induction phase; 4. Tra
Exclusion criteria
Exclusion criteria: 1. Patients with other risk factors: malignant hypertension, hypertensive emergencies, hypertensive crises, and hypertensive encephalopathy; or those with carotid ultrasound suggesting intimal-medial thickening (IMT=0.9mm), hypertensive ocular lesions, and other target organ damage; 2. History of angioedema, drug-related or due to other causes; 3. History or diagnostic basis of secondary hypertension, including but not limited to the following conditions: renal parenchymal hypertension, renal vascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary hyperaldosteronism, Cushing's syndrome, pheochromocytoma, cystic kidney disease, and drug-induced hypertension; 4. Hypertension combined with the following lesions: acute coronary syndrome occurring within the last 6 months, myocardial infarction, percutaneous coronary intervention, stroke; NYHA class II-IV heart failure, aortic aneurysm or dissection, third-degree AV block and second-degree AV block with heart rate 5.5mmol/L; serum ALT and/or AST >2.5× upper limit of normal (ULN); serum creatinine >1.5×ULN; any clinically significant laboratory abnormality that the investigator considers may interfere with the evaluation of the efficacy and/or safety data of this study; 6. Patients diagnosed with diabetes. 7. Patients with metabolic syndrome: A diagnosis can be made if there are 3 or more of the following criteria: 1) Abdominal obesity: Waist circumference male =90cm, female =85cm; 2) Elevated blood pressure: Blood pressure =130/85mmHg and/or previously diagnosed hypertension under treatment; 3) Dyslipidaemia: Fasting triglycerides =1.7mmol/L, fasting HDL-C 30kg/m2 (BMI = weight (kg)/height2 (m2)); 9. Patients with malignant tumours; 10. Patients on haemodialysis or those strictly undergoing salt-restricted therapy; 11. Gastrointestinal diseases or surgeries that may affect drug absorption or excretion, such as gastrointestinal resection, active gastrointestinal inflammation, ulcers, or gastrointestinal bleeding; 12. Known or suspected allergies to iron skin orchid chewing tablets or their components and related medications (CCB, ARB, ACEI, and renin inhibitors); 13. Use of various antihypertensive medications, anti-angina medications (except trimetazidine), digoxin, corticosteroids (except for topical corticosteroids), oestrogens, potassium supplements, and other chemical drugs, biological products, traditional Chinese medicine, or natural medicines deemed unsuitable by the investigator during the induction phase; 14. Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test; or subjects or their partners who cannot guarantee effective contraception during the trial period (acceptable contraceptive methods: true abstinence; intrauterine device; barrier contraceptive methods; or partner has undergone sterilisation. Unacceptable contraceptive methods: periodic abstinence, such as calendar, ovulation, or symptom tempe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic Blood Pressure Load Value.;Changes in average dynamic blood pressure and dynamic blood pressure load compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in average dynamic blood pressure and dynamic blood pressure load compared to baseline.;The difference in systolic and diastolic blood pressure from baseline.;Blood pressure control rate.;The change in the achievement rate of the ambulatory blood pressure mean compared to baseline.;Antihypertensive efficacy rate.;The change in the total score of TCM syndrome evaluations compared to baseline.; | — |
Countries
China
Contacts
Public ContactShuwei huang
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed