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The clinical trial of efficay and safety of Polygonum cuspidatum leaf capsule for the post-market revaluing

Polygonum cuspidatum leaf capsule monotherapy or combined with western medicine in the treatment of hypertensive disease (syndrome of hyperactivity of liver Yang) the effectiveness and safety of non blind, self control, single center after the listing of the re evaluation in clinical trials

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-15007528
Enrollment
Unknown
Registered
2015-10-28
Start date
2015-12-11
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hypertensive disease (syndrome of hyperactivity of liver Yang)

Interventions

Case series : Polygonum cuspidatum leaf capsule

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) In accordance with hypertension disease diagnostic criteria, Grade I hypertension patients; (2) syndrome of hyperactivity of liver yang for TCM; (3) TCM syndrome score >=4; (4) age: 18~45 years old; (5) Some-one not taking antihypertensive drugs in the past, or who have to consume a kind of the antihypertensive drugs of western-medicine for at least 14 days (only calcium antagonists, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists) but not yet get to the standard in blood pressure; (6) signed Informed Consent Form voluntarily.

Exclusion criteria

Exclusion criteria: (1) hypertension combined with the following lesions:with cerebral vascular accident for 6 months , myocardial infarction or heart failure; the history of large arteries Aneurysm or dissecting aneurysm; definite angina; malignant or potential malignant arrhythmia; (2) patients with secondary hypertension; 2, grade 3 hypertension; (3) Agents other than antihypertensive agents who previously taken in addition to calcium antagonists, angiotensin converting enzyme inhibitor, angiotensin II receptor antagonist (4) with 2 or more drugs are used at the same time,; (5) TCM syndrome score less than 4; (6) aged under 18 or over 65 years; (7) pregnant or lactating women, women who cannot guarantee contraception during the trial; (8) allergic constitution or allergic to a variety of drugs; (9) autoimmune diseases or any serious fatal disease; (10) mental illness, outof the self-control, can not be expressed exactly; (11) liver and kidney function damaged: AST or / and ALT are 2 times more than the upper limit of the normal value in 1.2 times and above; (12) severe cardiopulmonary dysfunction; (13) diabetes blood glucose controlling is not good, the level of the fasting blood glucose>11mmol/L, or a combination of symptoms (such as diabetic nephropathy, peripheral neuropathy, etc.); (14) who has been in other clinical trials before this trial in a month; (15) the clinician considers that the patient who should not be present in the trial; (16) Patients has been into the group of this study in the past.

Design outcomes

Primary

MeasureTime frame
Blood pressure measurement;24-hour ambulatory blood pressure;Hyperactivity of liver Yang Syndrome curative effect;

Countries

China

Contacts

Public ContactRong Li
lrhbs@126.com+86 020-36591441

Outcome results

None listed

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