An Open-Label Randomized Controlled Clinical Trial to Evaluate the Efficacy of Topical Draksha Ghrita for Treatment of Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
研究概览
简要总结
DED is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.
Treatment of DED typically involves various approaches such as ophthalmic anti-inflammatory agents, autologous serum tears, punctal occlusion, eye side shields, systemic cholinergic agents, incorporating essential fatty acids, and adopting environmental strategies. Additionally managing DED requires lifelong treatment as there is no curative remedy available in conventional medicine, only palliative measures. The primary focus for the management of DED lies in addressing the relentless inflammatory cycle. However, the use of topical steroids for a long period can be harmful because of adverse effects associated with it.
Ayurvedic drugs have been in use for centuries and have the potential to be effective on multifactorial interlinked complex pathology. It describes several medical formulations and topical therapeutic procedures to treat DED efficiently. Aschyotana is considered the first and foremost ocular therapeutic procedure for all type of eye diseases.
This study will compare the changes in signs and symptoms of Dry Eye Disease between the intervention and the control groups and also compare the changes in human tear proteomes between both groups following Draksha Ghrita eyedrop for 1month and assess treatment effectiveness at the protein level according to treatment regimen.
Draksha contain polyphenols have ocular protective activities like anti oxidant, antimicrobial, anti aging and anti inflammatory properties. Purana Ghrita is having anti-oxidant, rejuvenating, wound healing properties. Forms a uniform layer over ocular surface which bring a smoothening effect to eyes. So overall effects of Draksha Ghrita can prevent the ocular surface inflammation, tear film instability associated with dry eye disease and can bring the normal ocular surface homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed ICF (Informed Consent Form) Patients presenting with signs and symptoms of Dry eye Disease Age group 18-50 years TFBUT (Tear Film Break-up Time)less than or equal to 10 Seconds.
- •CFS (Corneal Fluorescein Staining) Schirmer’s test less than 10mm.
排除标准
- •Cases with any ocular history even in one eye, ocular injury, ocular infection, eyelid disease, lid abnormalities Known allergies Autoimmune disease Patients who use contact lens Other oral steroids, oral cyclosporine, anti glaucoma medication within 60 days before screening Patients suffering from any systemic disorder or taking any medications History of ocular surgery within 6 months prior to enrolment Stevens-Johnson syndrome Sjogren’s syndrome Patient who starts developing complications will be excluded from the study Patient not willing for the treatment.
研究者
Ajisha P
Banaras Hindu University