Chinese Medicine Treat for Hypertensive Renal Injury
Ključne riječi
Sažetak
Opis
Hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. The higher the blood pressure level, the higher the risk of these diseases. Antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. A multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of Chinese medicine (Qianyanguuyin formula) in improving urinary albumin to creatinine ratio (ACR), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). Patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (ACR of 30-300 mg/g) and eGFR of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome. It's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.
Datumi
| Posljednja provjera: | 08/31/2019 |
| Prvo podneseno: | 09/01/2019 |
| Predviđena prijava predata: | 09/01/2019 |
| Prvo objavljeno: | 09/05/2019 |
| Zadnje ažuriranje poslato: | 09/03/2019 |
| Posljednje ažuriranje objavljeno: | 09/05/2019 |
| Stvarni datum početka studija: | 09/09/2019 |
| Procijenjeni datum primarnog završetka: | 06/29/2021 |
| Predviđeni datum završetka studije: | 12/29/2021 |
Stanje ili bolest
Intervencija / liječenje
Drug: Losartan 100Mg Tab
Drug: losartan & qianyangyuyin
Drug: Losartan & Placebo
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: losartan & qianyangyuyin Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Chinese Medicine (Qianyangyuyin granule) 20g by mouth, bid for 6 months. | Drug: losartan & qianyangyuyin 20g, Granule, bid, po, 6 months |
| Placebo Comparator: Losartan & Placebo Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months. | Drug: Losartan & Placebo Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 35 Years To 35 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - Subject has primary hypertension(grades 2-3) - Subject has microalbuminuria [defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min∙1.73m2)] - Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome - Subject voluntarily participates in the trial and signs informed consent Exclusion Criteria: - Subject has secondary hypertension - Subject with pregnancy or lactating - Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia - Subject's liver function (AST or ALT) is 2 times greater than normal value - Subject has history of mental illness - Subject currently participates in other drug clinical trials |
Ishod
Primarne mjere ishoda
1. albumin-to-creatinine ratio(UACR) [6 months]
Sekundarne mjere ishoda
1. Ambulatory blood pressure level [6 months]
2. Office blood pressure level 6/5000 Office blood pressure level [6 months]
3. Traditional Chinese Medicine syndrome scores [6 months]
