A clinical study and animal study on testing the effect of Ayurvedic drug Amalaki Rasayan in Glaucoma

Phase 1

Conditions: Health Condition 1: H401- Open-angle glaucoma

Registration Number: CTRI/2019/04/018451

Lead Sponsor: Department of Shalakyatantra Government Ayurved College and Hospital Nagpur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients suffering from symptoms of Primary Open Angle Glaucoma (Adhimantha) and free from any other complications. ( IOP >21 mm Hg, cup: disc ratio (CDR) >=0.5 in either eye, difference in CDR >0.2 between the two eyes and/or the presence of glaucomatous features)

2. Patients of age group of 30 to 70 years (Both inclusive).

3. Patients of either gender.

Exclusion Criteria

1.Patients with advanced glaucoma (mean deviation >15 decibels) were excluded, as well as those with evidence of exfoliation, pigment dispersion, or prior filtration surgery.

2. All Primary Closed Angle Glaucoma and secondary Glaucoma.

3. Senile mature or hyper mature cataract.

3. Visual acuity of less than 6/60.

4. Congenital, traumatic, complicated & metabolic cataract or traumatic rise in IOP.

5. Any ocular pathology that can cause diminution of vision and increase in IOP.

6. Patients associated with any systemic illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amalaki Rasayan is effective in preventing the Retinal Ganglionic cell loss in Primary Open Angle Glaucoma Rat model. <br/ ><br> <br/ ><br>Timepoint: The drug will be administer for 30 day to rat.There will be 5 groups of rat. Each group will contain 6 animals.The rats will be assessed before and after treatment and retinal ganglion cell count will be taken after treatment. Total duration of the animal trial will be approximately 2 months.

Secondary Outcome Measures

Name	Time	Method
Participants showing relief from clinical sign and symptoms and improvement in visual acuity. Stopped deterioration of visual field defect. The parameters to be evaluated for secondary outcome are visual field defects on perimetry, Intraocular presssure, Redness of eyes, Headache.Timepoint: The drug willbe given for 60 days. The patients will be assessed before and after treatment. The parameter to assess the secondary outcome will be evaluated after 60th day.Total duration of the study will be 24 months