A randomized clinical trial to evaluate the neuroprotective effect of Ayurveda treatment protocol (AY/SHA/NIA/POAG/2024)as an adjuvant therapy in Kaphaja Adhimantha with special reference to primary open angle glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in pattern deviation in RNFL thickness through OCT
研究概览
简要总结
Introduction
Glaucoma is one of the leading cause of blindness in the world, marked by gradual damage to the optic nerve that leads to particular abnormalities in the visual field and alterations in the optic disc.Although high intraocular pressure (IOP) is frequently associated with it, the condition can still worsen even when IOP is under control.This illness is similar to Adhimantha, a Sarvagata Netra Roga which if left untreated, can result in Drishti Nasha, or vision loss. Visual impairment results from the progressive loss of retinal ganglion cells, which can cause problems in the central and peripheral visual fields. Increased outflow resistance, damages ganglion cell fibres, and is mostly caused by elevated IOP, however normal-tension glaucoma can also undergo similar alterations.
Intervention
Group A trial group
purwa karmathree sittings of purwa and pradhana larma along with Netrashani Rasa along with conservative treatment anti Glaucoma medicines
Netra parisheka with Triphaladi Kwatha
Marsh Nasya with Ksheerbala Tail
Mridu virechana with Triphala churna
Pradhana Karma
Netra Tarpana with Yashtyadhya Ghrita
Group B
Standard control group with Anti Glaucoma medicines
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria 1.All patients with primary open angle glaucoma who exhibit the signs and symptoms of Kaphaja Adhimantha, including Shopha, Srava and Shirahshula, Rupam Pashyati Dukhen 2.Patients aged between 30-70 years.
- •3.Best corrected visual acuity (BCVA) more than 6/
- •4.Patients with IOP in range between 22-30 mm of Hg.
排除标准
- •Exclusion criteria 1.Other types of glaucoma, including inflammatory, trauma-induced, exfoliative, pigmentary, and closed-angle glaucoma, as well as developmental glaucoma.
- •2.Glaucoma with hazy media that interferes with fundus examination and visual field mapping.
- •3.POAG with advanced stage of Optic atrophy with blindness.
- •4.Patients who have undergone Glaucoma surgery.
- •5.Patients who have undergone any ocular surgical intervention within 3 months.
- •6.Patients with any systemic illness which may affect the drug in clinical study.
结局指标
主要结局
Changes in pattern deviation in RNFL thickness through OCT
时间窗: From baseline to day 61
次要结局
- Changes in Visual acuity and sign and symptoms of Kaphaja Adhimantha with special reference to Primary Open Angle Glaucoma(From baseline to day 61)
研究者
Dr Kalpana Chhaniwal
National Institute of Ayurveda Jaipur