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A randomized, double-blind, placebo-controlled trial of Lingze antihypertensive intervention in primary hypertension

A randomized, double-blind, placebo-controlled trial of Lingze antihypertensive intervention in primary hypertension

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051861
Enrollment
Unknown
Registered
2021-10-08
Start date
2021-10-10
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Grade 1 hypertension

Interventions

Experimental group:Lingze Jiangya decoction combined with lifestyle intervention
Control group:Placebo combined with lifestyle intervention

Sponsors

Hainan Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The blood pressure in the resting sitting consultation room before enrollment is 140-159/90-99 mm Hg, which is in line with the TCM diagnosis of excess liver-fire syndrome or excess phlegm-dampness syndrome; 2. Not taking antihypertensive drugs before, or taking the same antihypertensive drugs regularly in the past 2 weeks; 3. Aged 18-65 years, no gender limit; 4. No language and intellectual disability, can answer and fill in the questionnaire smoothly; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Use of other drugs (excluding antihypertensive drugs) that affect blood pressure in the past month: such as hormone drugs, central nervous system drugs, non-steroidal anti-inflammatory drugs, etc.; 3. Patients diagnosed with senile hypertension, female menopausal hypertension, hypertension with diabetes, cerebrovascular disease, heart disease, kidney disease, peripheral vascular disease, and retinopathy; 4. Suspect or have a history of alcohol or drug abuse; 5. Those who are planning to become pregnant, patients of childbearing age who are not contraceptive, pregnant and lactating patients; 6. Patients who have participated in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Changes of systolic blood pressure in resting sitting consulting room compared with baseline (week 0) at week 12;

Secondary

MeasureTime frame
Changes of systolic blood pressure in resting sitting room compared with baseline at other times;Changes of diastolic blood pressure in sitting room from baseline;Blood pressure control rate;Use of antihypertensive drugs;International physical activity questionnaire (IPAQ);Brief health status questionnaire 12 items (SF-12);TCM symptom score of hypertension;

Countries

China

Contacts

Public ContactCheng Yawei

Hainan Hospital of Traditional Chinese Medicine

yaweicheng@126.com+86 13389860305

Outcome results

None listed

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