Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Triphala ghrita and Anu taila: A. Triphala Ghrita : For Aschyotana (AFI, Part I, 6:14, Pg.No. 85)
Dose : 0.1 ml (0.05 ml in each eyes)
Dosage form : Ghee (ghrita)
Route of Admini
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the status and progression of Dry Age-Related Macular Degeneration (Jarajanya Drishtigata Roga) as assessed through Visual AcuityTimepoint: Baseline, 29th day, 85th day,141st day, 169th day, at the end of 4 weeks follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Changes in size of drusens as assessed through SD-OCTTimepoint: Baseline, 29th day, 85th day,141st day, 169th day, at the end of 4 weeks follow up;Changes in DLTV (Daily Living Tasks Dependent on Vision) ScoreTimepoint: Baseline, 29th day, 85th day,141st day, 169th day, at the end of 4 weeks follow up;Clinical safety assessed through CBC, Lipid profile, Protein Profile, Glucose profile, LFT, KFT and ADR/ ADEsTimepoint: Baseline, 29th day, 85th day,141st day, 169th day, at the end of 4 weeks follow up | — |
Countries
India
Contacts
Public ContactKrishna Kumar V
Regional Ayurveda Research Institute for Eye Diseases
Outcome results
None listed