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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Cohort Study to Investigate the Efficacy of Tianzhi Granules in the Treatment of Hypertension-Associated Mild Cognitive Impairment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Cohort Study to Investigate the Efficacy of Tianzhi Granules in the Treatment of Hypertension-Associated Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001674
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Mild cognitive impairment due to hypertension

Interventions

treatment group:Basic Western medicine treatment + Tianzhi Granules
control group:Basic treatment with Western medicine + Tianzhi Granules placebo

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with essential hypertension. (2) For those who meet the diagnostic criteria for mild cognitive impairment, 18=MoCA score =26; (3) Age =50 years old and =75 years old, gender not limited; (4) Those who meet the diagnostic criteria for hyperactivity of liver Yang syndrome; (5) Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) There are already clear other causes of cognitive impairment (such as Alzheimer's disease, stroke, etc.); (2) Pregnant women, or those planning to become pregnant in the near future, or women who are breastfeeding; (3) Severe damage to heart, liver and kidney functions, as well as serious and even life-threatening diseases in other systems; (4) The research subject himself/herself is unable to cooperate due to reasons such as alcoholism or intellectual disability; (5) Have participated in or are currently participating in other clinical researchers in the past 4 weeks; (6) Those who are allergic to the drugs used in the test; (7) Having used cholinesterase inhibitors, methamphetamine, hormone replacements, systemic glucocorticoids, antipsychotic drugs or drugs known to affect cognition in the past three months; (8) Other circumstances that other researchers consider unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale;

Secondary

MeasureTime frame
Mini-mental State Examination Scale;blood pressure;Activities of Daily Living Scale;fMRI;optical coherence tomography;eye-ground photography;TCM syndrome points;fasting blood-glucose;fasting insulin;Fasting C-peptide;triglyceride;total cholesterol;low density lipoprotein;high-density lipoprotein;Interleukin-1 ß;Interleukin-6;ECG;blood routine examination;routine urine test;Routine Stool Test;Aspartate aminotransferase;Alanine Aminotransferase;creatinine;Urea nitrogen;Uric acid;serum potassium;Blood sodium;Blood Chloride;

Countries

China

Contacts

Public ContactFu Deyu

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

fdy650@126.com15156258536

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026