Skip to content

Systematic evaluation of the clinical efficacy and intervention research of Qihuang Granules for dry AMD based on the theory of syndrome-disease combination

Systematic evaluation of the clinical efficacy and intervention research of Qihuang Granules for dry AMD based on the theory of syndrome-disease combination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123952
Enrollment
Unknown
Registered
2026-05-04
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Dry age-related macular degeneration

Interventions

Trial Group:Qi Huang Granules (10g per bag, composed of Lycium barbarum, Cornus officinalis, Leonurus heterophyllus, Salvia miltiorrhiza, Platycodon grandiflorum, Bupleurum chinense, etc.), 1 bag thre
Control Group:Lutein Tablets (10mg lutein per tablet), 1 tablet once daily orally, continuous treatment for 3 months

Sponsors

Guangdong Second Traditional Chinese Medicine Hospital(Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 50–79 years, regardless of gender; 2. Meet the diagnostic criteria of dry AMD; 3. Meet the TCM syndrome criteria of liver-kidney yin deficiency and phlegm-stasis interminglement for dry AMD. 4. Patients without prior anti-VEGF, laser or surgical treatment; 5. Patients with good compliance who can cooperate with ophthalmic examinations, complete standardized treatment, voluntarily provide clinical data, and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. With concurrent wet AMD, diabetic retinopathy, glaucoma or other vision-affecting ocular fundus diseases; 2. Received anti-VEGF drugs, glucocorticoids, immunosuppressants or other Chinese medicines for AMD within the recent 3 months. 3. Abnormal hepatic and renal function: ALT/AST > 1.5 × ULN, serum creatinine > ULN; 4. Allergy to Qihuang Granules or lutein. 5. Not conforming to the TCM syndrome pattern of Liver-Kidney Yin Deficiency combined with Phlegm-Stasis Interminglement. 6. Those with cognitive impairment, mental illness, or other conditions that prevent them from cooperating in follow-up.

Design outcomes

Primary

MeasureTime frame
Retinal vascular flow density;Hemorheological parameters;NEI VFQ-25;Best-corrected visual acuity;Serum levels of the inflammatory cytokines IL?1ß, IL?18, and NLRP3;Multi-spatial frequency contrast sensitivity function;Choroidal blood flow density and thickness;Amsler grid;Drusen volume;

Countries

China

Contacts

Public ContactWang Yan

Guangdong Second Traditional Chinese Medicine Hospital(Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine)

wangyan96000@126.com+86 20 83598909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026