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A multi-center, randomized, double-blind, double-simulated, and positive-drug parallel-controlled clinical study to evaluate the effectiveness and safety of Quanduzhong capsule in treating essential hypertension (nephrasthenia syndrome)

A multi-center, randomized, double-blind, double-simulated, and positive-drug parallel-controlled clinical study to evaluate the effectiveness and safety of Quanduzhong capsule in treating essential hypertension (nephrasthenia syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045216
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-06-30
Completion date
Unknown
Last updated
2021-11-16

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

Group 1:Quanduzhong capsule
Group 2:Eucommia granules

Sponsors

Beijing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnose with essential hypertension; 2. Stage 1-2 hypertensionclinical blood pressure:mean sitting systolic blood pressure 140-179mm Hg and mean sitting diastolic blood pressure 90-109mm Hg without severe target organ damages; 3. Subjects who meet the standard of TCM kidney deficiency syndrome differentiation; 4. Aged between 18-70 years old, male or female; 5. The subject are allowed to have the following conditions: (1) The subject has not previously been diagnosed with hypertension or has not received antihypertensive treatment; (2) The subject has been diagnosed with hypertension in the past, but has not taken antihypertensive drugs regularly, and has not taken any antihypertensive drugs within 2 weeks before participating this tial; 6. Subjects are volunteered to signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects are diagnosed with chronic congestive heart failure NYHA grade III and IV or acute coronary syndrome, transient ischemic attack, myocardial infarction, percutaneous coronary intervention, stroke in the past 6 months before participating this trial; 2. Subjects with severe heart disease such as aortic aneurysm or aortic dissecting aneurysm, unstable angina, cardiogenic shock, arrhythmia requiring treatment, valvular disease, hypertrophic cardiomyopathy, rheumatic heart disease, etc. in the past or at present; 3. Subjects who is known or suspected to has secondary hypertension, hypertensive emergency or sub-emergency, hypertensive crisis; 4. Subjects who cannot tolerate the 2-week run-in period; 5. Combined with other primary serious liver, kidney or blood system diseases or malignant tumors, with ALT and AST exceeding 1.5 times the upper limit of normal value, and Cr exceeding the upper limit of normal value; 6. Subjects with poorly controlled diabetes, fasting blood glucose> 10.0 mmol/L; 7. Subjects with gastrointestinal surgery that may significantly change the absorption, distribution, metabolism and excretion of drugssuch as gastrectomy, gastrointestinal anastomosis or bowel resection, gastric bypass, gastrointestinal band surgery etc. 8. Woman during pregnancy or lactation or those who have a birth plan during this trial or 3 months after the end of this trial; 9. Excessive smoking >10 cigarettes/day and/or alcoholism drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits, or about 100 ml of wine; 10. Subjects with mental disorders or subjects who is known or suspected to has a history of drug abuse; 11. Subjects whose blood pressure is affected due to occupational factors and other reasons such as working at heights, motor vehicle driving with dangerous mechanical operations, working hours are night shifts 11 pm [23:00] to 7 am [07:00], only applicable to those with ambulatory blood pressure monitoring; 12. Subjects who participated in other clinical trials in the past 3 months; 13. Subjects who are inappropriate to participate in this research.

Design outcomes

Primary

MeasureTime frame
clinical blood pressure;

Secondary

MeasureTime frame
24 hour ambulatory blood pressure;curative effect of TCM Syndrome;

Countries

China

Contacts

Public ContactLiu Hongxu

Beijing Hospital of Traditional Chinese Medicine

lhx_@263.net+86 13501161583

Outcome results

None listed

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