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Study on the mechanism of Xuanshen Yishen prescription based on intestinal flora in the intervention of kidney and Yin-yang deficiency syndrome in elderly hypertensive patients

Study on the mechanism of Xuanshen Yishen prescription based on intestinal flora in the intervention of kidney and Yin-yang deficiency syndrome in elderly hypertensive patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000843
Enrollment
Unknown
Registered
2024-12-18
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Senile hypertension

Interventions

Blank control group:Lifestyle intervention + Western medicine routine antihypertensive drug treatment
Chinese medicine intervention group:Lifestyle intervention + Western medicine routine antihypertensive drug treatment + Xuanshen Yishen mixture intervention

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It meets the diagnostic criteria of elderly hypertension and TCM syndrome of kidney and yin-yang deficiency; 2. Essential hypertension no antihypertensive drugs used in the past or three times on different days one week after elution blood pressure reached the diagnostic criteria; In patients with grade 3.1 and 2 hypertension blood pressure must meet: 140mmHg= systolic < 180mmHg 90mmHg= diastolic < 110mmHg; 4. Between 65 and 75 years old (including 65 and 75 years old); Grade 5.1 or grade 2 hypertension must be longer than 3 months; 6. Give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Under 65 years of age or over 75 years of age; 2. Secondary hypertension; 3. Systolic blood pressure < 140mmHg diastolic blood pressure < 90mmHg; 4.3 grade hypertension; 5. Combined with mental illness; 6. Have a history of myocardial infarction or obvious stroke in half a year; 7. Allergy or multiple drug allergy; 8. Patients who have received clinical trials of other new drugs within the last 3 months; 9. Patients with Grade I hypertension whose course of disease is less than 3 months; 11. Patients who have used antibiotics in the last 3 months; 12. Eat yogurt or other food or medicine containing live bacteria in the past 3 months; 13. Combined with the following clinical manifestations of organ damage such as: unstable angina pectoris myocardial infarction heart failure transient ischemic attack (TIA) stroke hypertensive encephalopathy retinal hemorrhage exudate with or without papilledema blood creatinine greater than 177umol/L arterial dissection and arterial occlusive disease. Any of the above items can be excluded. Note: Any one or more of the above items should be excluded and cannot be included.

Design outcomes

Primary

MeasureTime frame
Vital sign;Intestinal flora sequencing;Serum short chain fatty acids;Fecal short-chain fatty acids;TCM syndrome integral;

Secondary

MeasureTime frame
Compliance index;

Countries

China

Contacts

Public ContactJie Yu

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

yujie1980learn@126.com18560769020

Outcome results

None listed

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