Clinical study on Vasant Kusumakar Ras in Diabetic Retinopathy

Phase 2

Completed

• Conditions: Health Condition 1: null- Diabetic Retinopathy

• Registration Number: CTRI/2018/06/014466
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosed with diabetes mellitus (type I & II).

2. Diagnosed with non-proliferative diabetic retinopathy (mild to Moderate cases), in whom panretinal photocoagulation is not imminently required in the ophthalmologistâ??s judgment.

3.Best corrected ETDRS VA in study eye >=49 letters (20/100)

4. HbA1C between 6 to 9 %.

5.Able and willing to give informed consent

Exclusion Criteria

1.Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.

2.The patients who have been received the therapy of Retina laser photocoagulation.

3.The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.

4.Retinal conditions which may mask assessment e.g. retinal vein occlusion

5.Systolic blood pressure greater than 180 mm of hg or diastolic blood pressure greater than 110 mm of hg

6.History of major ocular surgery (scleral buckle, any intraocular surgery etc in the study eye within prior 6 months

7.DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.

8.History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week.

9.Previous treatment with intravitreal or sub tennon triamcinilone within the past 3 months in the study eye.

10.Previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals)

11.Subject with other severe Diabetic complication.

12.Having known allergic reaction to ingredients of Vasant Kusumakar Ras

13.Pregnant or breast feeding.

14.Subjects with glaucoma, uveitis, ocular neuropathy and severe cataract etc.

15.Participated in other clinical trial within 3 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of effect of Vasant Kusumakar Ras Vs. Placebo on Diabetic Retinopathy (NPDR- Mild to Moderate) by Fundus Photography. The assessment will be done to evaluate if there is slowing of deterioration, induce regression or slowing of progression or improvement in retinal condition in mild to moderate NPDR- Non Proliferative Diabetic RetinopathyTimepoint: Day -7, Day 0, Day 30, Day 60, Day 120, Day 150, Day 180

Secondary Outcome Measures

Name	Time	Method
1.Review of literature of Prameha, Madhumeha, Diabetes Mellitus and Diabetic Retinopathy <br/ ><br>2.Review of literature of each ingredient of Vasant Kusumakar Ras. <br/ ><br>3.Development of methods of analysis for the ingredients of Vasant Kusumakar Ras. <br/ ><br>4.Assessment of Safety of Vasant Kusumakar Ras by evaluating Adverse events <br/ ><br>5.Assessment of safety of Vasant Kusumakr Ras by evaluating Clinically significant Laboratory Parameters (CBC, Lipid Profile, Renal Profile, Liver Profile etc)Timepoint: Day -7, Day 0, Day 30, Day 60, Day 120, Day 150, Day 180