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Clinical study of Qianyang Yuyin granule on normal high blood pressure based on intestinal flora and metabonomics

Clinical study of Qianyang Yuyin granule on normal high blood pressure based on intestinal flora and metabonomics

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086868
Enrollment
Unknown
Registered
2024-07-12
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Hypertension

Interventions

Control Group:Lifestyle Intervention
Qianyang Yuyin granule placebo 20G/time, taking with warm water in the morning and evening
Treatment Group:Life style intervention
Qianyang Yuyin granule 20G/time, taking with warm water in the morning and evening

Sponsors

Jiangsu Provincial Hospital of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) age 18-65 years, gender is not limited, 2) diagnostic criteria of normal high blood pressure: without the use of antihypertensive drugs, the mean sitting systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) of brachial artery were 120-139 mmhg and 80-89 mmhg, respectively The mean sitting systolic blood pressure (SBP) of brachial artery was 115-135mmHg, and/or mean sitting diastolic blood pressure (DBP) of 75-85 mmhg) , 3) were able to perform mild to moderate exercise, 4) voluntarily participated in the trial and signed an informed consent form

Exclusion criteria

Exclusion criteria: 1) secondary high normal blood pressure caused by other causes such as primary aldosteronism, hypercholesterolemia, or severe dysfunction or malignant diseases of important organs such as heart, liver, kidney, hematopoietic system, or metabolic diseases such as diabetes, hyperlipidemia, and Hyperuricemia; 2) patients who were treated with antihypertensive drugs 2 weeks before admission; 3) the use of antibiotics, probiotics, microbial preparations, Proton-pump inhibitor, various types of proprietary Chinese medicines (including but not limited to Xiaochaihu decoction, Yupingfeng powder, Sijunzi decoction, etc.) , traditional Chinese medicine decoction, Chinese medicine instead of tea drink, etc. 4) history of gastrointestinal tract disease (including diarrhea and constipation in the last 1 month) , history of digestive tract operation ,5)and other relevant medical history affecting intestinal flora ,6) excluding pregnant and lactating women; 7)excluding allergic constitution or known allergy to drug ingredients.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Lifestyle scale integral;

Countries

China

Contacts

Public ContactFang Zhuyuan

First Nanjing University of Chinese Medicine Medical College (Jiangsu Provincial Hospital of traditional Chinese medicine)

fangzhuyuan@njucm.edu.cn+86 139 5161 7800

Outcome results

None listed

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