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Observation on the Effectiveness of M-TCM Milk in Preventing Myopia in Children and Adolescents at the Early Stage of Myopia - A Randomized Controlled Multi-center Clinical Study

Observation on the Effectiveness of M-TCM Milk in Preventing Myopia in Children and Adolescents at the Early Stage of Myopia - A Randomized Controlled Multi-center Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002405
Enrollment
Unknown
Registered
2025-12-06
Start date
2024-12-17
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Myopia

Interventions

CONTROL Group:Subjects drank one carton of pure milk per day for 1 year.
Research Group:The subjects drank one carton of M-TCM every day for 1 year

Sponsors

Ineye Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria: Children and adolescents aged 1.6~12 years old (including boundary values) male or female; 2. Binocular -0.50D< equivalent spherical power =+0.75D and astigmatism = 1.00DC; 3. Unaided visual acuity= 4.9; 4. The person or (and) the guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following are excluded: 1. Those who have been diagnosed with myopia; 2. Amblyopia and strabismus glaucoma cataract fundus disease and other ocular organic lesions; 3. Active ocular inflammation in either eye (e.g. blepharitis infectious conjunctivitis keratitis scleritis uveitis endophthalmitis); 4. Those with uncontrolled systemic or debilitating diseases and immune deficiencies combined with serious cardiovascular hepatic renal and hematopoietic system and other primary diseases immune system diseases and mental illnesses; 5. Adopt optical correction methods drugs red light and other myopia prevention and control intervention methods within 3 months; 6. Participated in other clinical studies within 3 months; 7. Allergies: lactose intolerance or allergy to the ingredients in milk; 8. Those who are considered unsuitable by the investigator to participate in clinical studies.

Design outcomes

Primary

MeasureTime frame
Difference in myopia incidence between the study group and the control group over 1 year.;

Secondary

MeasureTime frame
The differences in the rate of hyperopia reserve consumption and the amount of axial length increase between the study group and the control group.;

Countries

China

Contacts

Public ContactWen Juan

Ineye Hospital of Chengdu University of Traditional Chinese Medicine

wenj4551668@126.com13808048959

Outcome results

None listed

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