Ayurveda-Based Integrative Management Of Diabetic Retinopathy
Phase 3
- Conditions
- Health Condition 1: H350- Background retinopathy and retinalvascular changesHealth Condition 2: H352- Other non-diabetic proliferative retinopathy
- Registration Number
- CTRI/2018/09/015683
- Lead Sponsor
- Dr GG Gangadharan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Non insulin dependent diabetes mellitus
-Mild to Moderate Diabetic Retinopathy
Exclusion Criteria
-Patients with H/O Previous treatment for diabetic retinopathy, including laser and Anti- VEGF drug.
-Presence of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
-Other ophthalmic conditions such as Cataract etc.
-Presence of diabetic nephropathy or cardiovascular disease
-Pregnancy or Lactation
-HbA1C >10%
-Statin Use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Significant decrease in the frequency and severity of manifestations of diabetic retinopathy(DR), including cotton wool spots, dot and blot hemorrhages and macular exudatesTimepoint: Assessment done at baseline and 6months with Optical Coherence Tomography(OCT) <br/ ><br>Fundus Photography(FP), Visual Acuity(V/A) and Visual Function Questionnaire(VFQ) will be done at baseline, three and six months.
- Secondary Outcome Measures
Name Time Method -Significant reduction of macular thickness measured using OCT in patients with diabetic macular edema. <br/ ><br>-No significant loss of vision,i.e reduction of visual acuity by 2 lines or more on the LogMAR chart, not attributable to other visual disorders such as cataract. <br/ ><br>-Improvement or no worsening of visual function and quality of life at the end of the Study period.Timepoint: Assessment done at baseline and 6months with Optical Coherence Tomography(OCT) <br/ ><br>Fundus Photography(FP), Visual Acuity(V/A) and Visual Function Questionnaire(VFQ) will be done at baseline, three and six months.