A Clinical trial to study the effect of an Ayurvedic drug in patients of Diabetic Macular Edema

Phase 2/3

Completed

Conditions: Diabetic patients with Diabetic Macular Edema

Registration Number: CTRI/2018/05/013658

Lead Sponsor: Ruby Kumar

Brief Summary: **Purpose:** Toinvestigate the potential of *Vidanga Rajanyadi Kashaya* (VRK), atraditionally used Ayurvedic polyherbal formulation to reduce edema and improvevision in patients of center-involved diabetic macular edema (DME).

**Design:** Prospective,single-center, randomized, single-blind, placebo-controlled clinical trial.

**Participants:** A totalof80 eyes of 80center-involved DME patients were randomly allocated to receive placebo (n=41) orVRK extract (n=39).

**Methods:** VRKextract 500 mg or placebo was administered orally twice in a day for 6 monthsand results were analyzed.

**Main Outcome Measures:** Primaryoutcome measures were mean change from baseline in central retinal thickness(CRT), maximum retinal thickness (MRT), and total macular volume (TMV) asdetermined by spectral-domain optical coherence tomography. Secondary outcomemeasure was the mean change from baseline in best-corrected visual acuity(BCVA) after 3 and 6 months of treatment.

**Results:** Seventypatients (35 in each group) completed the study and results were analyzed. Oraladministration of VRK extract for 6 months resulted in significant mean improvementsin CRT of 90.4 Âµm (*p*=0.000), MRT of 72.7 Âµm (*p*=0.000), TMV of 0.7mm3 (*p*=0.000) and BCVA of 4.9 early treatment diabeticretinopathy study (ETDRS) letters (*p*=0.000 in the study eyes. Anincrease in CRT of 7.6 Âµm (*p*=0.538), MRT of 34.7 Âµm (*p*=0.021),TMV of 0.4 mm3 (*p*=0.059) and decrease in BCVA of 1.5 ETDRSletters *(p*=0.063) in the placebo group was observed at 6 months. Nosignificant ocular or systemic adverse events related to VRK 500 mg extractwere observed or reported during the study.

**Conclusion:** Twicedaily 500 mg extract of oral VRK administered for 6 months demonstratedsignificant improvement in edema and visual acuity in patients withcenter-involved DME that warrants further studies investigating thepharmacokinetics and pharmacodynamics of the drug VRK.

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Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

At least one eye must meet all of the following criteria: a) Patients equal to or more than 18 years of age, diagnosed with Type 2 diabetes mellitus having decreased vision due to macular edema associated with non-proliferative (mild to moderate) diabetic retinopathy (DR). b) Patients with severe non-proliferative DR not willing to receive any conventional therapy for diabetic macular edema during next 6 month. c) Diagnosis of diabetes mellitus (Type 2).
Any one of the following will be considered to be sufficient evidence that diabetes is present:.
Current regular use of insulin for the treatment of diabetes.
Current regular use of oral antihyperglycemic agents for the treatment of diabetes.
Documented diabetes by WHO guidelines d) Best corrected ETDRS visual acuity score equal to or more than 34 to 76 letters (approximately 6/9 to 6/60 Snellen equivalent). e) Definite central retinal thickening of equal to or more than 300 Î¼m due to diabetic macular edema detected by spectral domain OCT examination. f) Patients able and willing to provide informed consent. g) No expectation that subject will be moving out of the area of the study center during the next 6 months.

Exclusion Criteria

a) Patients of diabetic macular edema associated with Type I diabetes mellitus and with Proliferative DR. b) Patients with severe non-proliferative DR willing to go for any conventional therapy for diabetic macular edema. c) Conditions that would preclude participation in the study (e.g. unstable medical status including blood pressure and glycemic control).
Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 6 months. d) Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of intraocular surgery within 90 days before study entry. e) Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of the macular edema. f) Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome).
Glaucoma per se is not an exclusion. g) An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition). h) Patients with a history of acute coronary event or stroke, renal failure, pregnancy or lactation. i) Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination. j) Active participation in any type of intervention study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
b. To determine the change in central retinal thickness measured by optical coherence tomography (OCT).	3 month, 6 month
a. To determine the change in macular retinal volume measured by optical coherence tomography (OCT).	3 month, 6 month

Secondary Outcome Measures

Name	Time	Method
To determine the change in best corrected visual acuity measured by ETDRS method.	3 month, 6 month

Trial Locations

Locations (1): Institute of Medical Sciences
🇮🇳
Varanasi, UTTAR PRADESH, India
Institute of Medical Sciences
🇮🇳Varanasi, UTTAR PRADESH, India
Ruby Kumar
Principal investigator
8210002352
dr.rubybhu@gmail.com