A clinical study to see the effect of Ayurvedic drugs in management of macular degeneration due to ageing

Phase 3

• Conditions: Health Condition 1: H353- Degeneration of macula and posterior pole

• Registration Number: CTRI/2019/06/019667
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a.Patients of the age > 50years

b.Patients of signs and symptoms of dry ARMD based on OCT (Optical coherence tomography), CFP (Colour Fundus Photography) and Amsler Grid

c.Patients willing to participate in the study.

Exclusion Criteria

a.Either eye with previous or active sub-retinal neo-vascularization or choroid Neo-vascularization

b.Pigment epithelium detachment.

c.Either eye with a diagnosis of exudative (wet type) ARMD or Geographic Atrophy in macula.

d.Patients greater than 75 years of age

e.Uncontrolled hypertension (Systolic BP >160mmHg and/or Diastolic BP >100mmHg)

f.Uncontrolled Diabetes (HbA1c >8%).

g.Patients with Very high Dyslipidemia (T.Chol > 240 mg / dL, LDL >190mg/dL, HDL >60, Triglycerides > 500 mg/dL ) NCEP – ATP III Classification

h.Patients on Dyslipidemia medication.

i.Patients with Aspartate Amino Transferase (AST) and/ or Alanine Amino Transferase (ALT) > 2 times upper normal limit, or

j.Patients with S. Creatinine > the upper limits of the normal.

k.Patients with evidence of malignancy

l.H/O Hypersensitivity to the trial drug or any of its ingredients.

m.Continuing addiction to smoking and usage of tobacco in any form

n.Any pre-existing disease of eye like glaucoma, uveitis, cataract or any other intra ocular disease that leads to loss of visual acuity

o.History of ocular surgery within 06 months of time

p.History of any intra-ocular medication / invasive eye procedures within 06 months of time.

q.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified