Randomized controlled clinical study to assess the add-on effect of Mishreya (Foeniculum vulgare) Ark ashchyotan with Timolol eye drops in primary open angle glaucoma (POAG) with special reference to Kaphaja Adhimantha.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 1. To assess the changes in subjective symptoms of POAG (Kaphaj Adhimantha) in group A and group B.
研究概览
简要总结
Patients with POAG (Kaphaj Adhimantha ) will be informed about the trial and written consent will be taken. Interventions to both the groups will be given.
assessment will be done based on
subjective criteria
-
headache
-
ocular pain
-
difficulty in near vision
objective criteria
-
BCVA
-
IOP
-
MD of perimetry
-
NPA on RAF rule.
Data will be obtained and stastistical analysis will be done. Observations and
results will be done based on statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •40 -70 years old patient of POAG, with IOP less than 30 mm of Hg, CDR less than 0.7, visual acuity more than 6/60.
排除标准
- •Patients with all types of PCAG, cataract, secondary and developmental glaucoma including exfoliative glaucoma, pigmentary glaucoma, trauma induced inflammatory glaucoma, advanced glaucomatous optic neuropathy or optic atrophy.
- •Visual acuity less than 6/60
- •known cases of bronchial asthma, cardiac diseas or patient on steroid treatment.
结局指标
主要结局
1. To assess the changes in subjective symptoms of POAG (Kaphaj Adhimantha) in group A and group B.
时间窗: at baseline, 10th day, 20th day, 30th day, 60th day
2. To assess the pre and post study changes in BCVA, IOP, MD in Perimetry, NPA in RAF rule in group A and group B.
时间窗: at baseline, 10th day, 20th day, 30th day, 60th day
3. To study the efficacy of Mishreya Ark Ashchyotan and Timolol eye drops in POAG.
时间窗: at baseline, 10th day, 20th day, 30th day, 60th day
次要结局
- 3. To study Mishreya ark in detail(4. To study Ashchyotan in deatil and prepare its SOP.)
研究者
Dr Dipti Nene
Ayurved Vidya Prasarak Mandals Ayurved Mahavidyalay, Sion