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Clinical Pre-experiment for Post-market Reevaluation of Quanduzhong Capsule

Exploratory Research on Quanduzhong Capsule in Treating Essential Hypertension (nephrasthenia syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021690
Enrollment
Unknown
Registered
2019-03-05
Start date
2018-10-28
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Essential hypertension (nephrasthenia syndrome)

Interventions

Sponsors

Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medicine Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged between 40-75 years old, male or female; 2. diagnose with essential hypertension; 3. diagnose with nephrasthenia syndrome; 4. mild hypertension with Sitting Diastolic Blood Pressure 90-99mmHg and (or) Systolic Blood Pressure 140-159mmHg after introduction period; 5. Subjects are volunteered to participate in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. those who are known or suspected to be allergic to the test drug and its components; 2. those who can not withdraw all antihypertensive drugs during introduction period or those who are taking concomitant medications which are not permitted during this research or those who can not or are not willing to withdraw the concomitant medications which are not allowed to take; 3. severe hypertension or blood pressure is classified as high risk; 4. familial hypertension, malignant hypertension, hypertensive emergencies, hypertensive crisis, and hypertensive encephalopathy; 5. secondary hypertension, including but not limited to the following diseases: unilateral or double renal artery, polycystic kidney disease, hyperaldosteronism, aortic coarctation, Cushing's syndrome, pheochromocytoma; 6. combined with the following lesions: acute myocardial infarction within 6 months, cerebrovascular accident, transient ischemic attack, large aneurysm or dissection aneurysm, unstable angina, grade II-IV (NYHA classification) history of heart failure, grade II or above atrioventricular block, sick sinus syndrome, bradycardia (heart rate <50 beats/min), or ther malignant or potentially malignant arrhythmias such as atrial fibrillation; 7. those with serious liver,kidney or blood system diseases or malignant tumors; 8. those with gastrointestinal lesions or gastrointestinal surgery such as gastrointestinal resection, active gastrointestinal inflammation,ulcers or gastrointestinal bleeding in the past 1 year; 9. those with a reversed lifestyle or irregular sleep pattern; 10. woman during pregnancy or lactation or those who have a birth plan in the near future; 11. history of alcohol or drug abuse; 12. those with neurological or mental disorders who can not or are unwilling to cooperate; 13. those who are inappropriate to participate in this research; 14. those who participated in other clinical trials 3 months ago.

Design outcomes

Primary

MeasureTime frame
24 hour ambulatory blood pressure;Office blood pressure;

Countries

China

Contacts

Public ContactHU Jingqing

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medicine Science

gcp306@126.com+86 010-64089008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026