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Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.

NCT04552600 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-12

No results posted yet for this study

Summary

Diabetic retinopathy (DR) is a common complication of diabetes mellitus that leads to loss of vision and blindness among working age adults. An ideal adjunctive agent for treating DR hence should be polymorphic and possess antiangiogenic, neuroprotective, anti-inflammatory, anti-oxidant as well as anti-ischaemic properties.Natureceuticals Sdn Bhd assessed the efficacy of core ingredient of Nuvastatic™, Lanctos 75™ for the treatment and management of the diabetic retinopathic condition.

Conditions

Interventions

DRUG

Nuvastatic

Phase 1b Interventional, multi-centered, double-masked, randomized

OTHER

Placebo

Phase 1b Interventional, multi-centered, double-masked, randomized

Sponsors & Collaborators

  • Ministry of Agriculture, Malaysia

    collaborator UNKNOWN

  • Quest International University, Malaysia.

    collaborator UNKNOWN

  • Advanced Medical and Dental Institute (AMDI), Universiti Sains Malaysia

    collaborator UNKNOWN

  • Universiti Sains Malaysia

    collaborator OTHER

  • Natureceuticals Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Aman Shah Abdul Majid, Ph.D. · Quest International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-08-10
Completion
2022-08-10

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552600 on ClinicalTrials.gov