Multicenter RCT of Eye-Brain Imaging in Diabetes Neurovascular Coupling

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 1, 2026

Primary Completion Date

November 1, 2026

Study Completion Date

December 1, 2026

Conditions
Diabetes MellitusDiabetic RetinopathyCognitive ImpairmentNeurovascular Coupling
Interventions
DRUG

hypoglycemic treatment

"The diabetes management adheres to the The 2025 Guidelines for Standards of Diabetes Care issued by the American Diabetes Association (ADA)."

DRUG

Tangshen'an Granules

Tangshen'an Granules comprises a meticulously blended mix of Astragalus, Prepared Rehmannia Root, Dodder Seed, Kudzu Root, Millettia Speciosa Champ, Salviae Miltiorrhizae Radix et Rhizoma, Poria Cocos, and Polygala Tenuifolia. Tangshen'an Granules is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily.

DRUG

Ginkgo Leaf Tablets

The primary active ingredients of Ginkgo Leaf Tablets are ginkgo flavonoid glycosides and terpene lactones. The prescribed oral dosage is one tablet each time, administered three times a day.

DRUG

Mecobalamin Tablets

Mecobalamin Tablets primarily contain mecobalamin, which is a coenzyme-active form of vitamin B12. The prescribed oral dosage is 0.5mg, administered three times a day.

DRUG

placebo

The placebo contains 10% of the active ingredients in Tangshen'an Granules, formulated by controlling the concentration to mimic Tangshen'an Granules. The placebo is administered at a dosage of 9g, dissolved in boiling water, and taken three times daily.

Trial Locations (3)

610072

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu

618000

Deyang Hospital Affiliated to Chengdu University of Traditional Chinese Medicine, Deyang

628000

Guangyuan North Sichuan Diabetes Specialty Hospital, Guangyuan

All Listed Sponsors
lead

Hejiang Ye

OTHER