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

Experimental and Observational Study on The Efficacy of Amalaki Rasayan in Adhimanthaj Drishtinash w.r.t Primary Open Angle Glaucoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018451
Enrollment
20
Registered
2019-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H401- Open-angle glaucoma

Interventions

Intervention1: Amalaki Rasayan: A Sundried Amalaki Churna levigated with freshly prepared Amalaki Swaras in such proportion till Churna get wet and then trituration done. Triturated Amalaki Churna wil

Sponsors

Department of Shalakyatantra Government Ayurved College and Hospital Nagpur
Lead Sponsor
APT Research foundation
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Amalaki Rasayan is effective in preventing the Retinal Ganglionic cell loss in Primary Open Angle Glaucoma Rat model. 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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Hari Narayan Umale

Government Ayurved College and Hospital

drumaleayurved@gmail.com09423682026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026