A Randomized Controlled Clinical Trial of Jeevaniya Dravya siddha Ghrita Nasya and Netratarpan in comparison with Carboxymethyl Cellulose (0.5%) eyedrops in Shushkakshipaka with special reference to Dry Eye Disease.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Jeevaniya dravya siddha ghrita Nasya with Netratarpan is significantly effective than carboxy methyl cellulose (o.5%) eye drops in the management of Shushkakshipaka 9Dry Eye Syndrome).
研究概览
简要总结
TITLE
A Randomized Controlled Clinical Trial of Jeevaniya Dravya siddha Ghrita Nasya and Netratarpan in comparison with Carboxymethyl Cellulose (0.5%) eyedrops in Shushkakshipaka with special reference to Dry Eye Disease
ASSESSMENT CRITERIA: Selected patients will be treated with Jeevaniya Dravya Siddha Ghrit Nasya Netratarpan and Carboxy methyl cellulose eyedrops,
grades of symptoms will be noted in each follow-up and compared to initial values.
Subjective criteria:
-
Ruksha vartma grade 0 / 1 (Absent/ Present)
-
photophobia grade 0 /1 (Absent /Present)
-
Gharsha grade0 /1 (Absent /Present)
-
Redness grade0 /1 (Absent /Present)
-
Toda (Pricking Pain) grade0 /1 (Absent /Present)
Objective criteria:
1.Visual acuity assessed by Snellen’s chart
- Dryness of eyes to be assessed by Schirmer’s test, Rose Bengal test, Tear Film break up test.
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
- •Patients showing symptoms of Shushkakshipaka (Dry Eye Syndrome)
- •Patients with dryness of eyes with or without pain/pricking sensation, photophobia, and mild redness, less flow of tears, foreign body sensation, scratchy sandy feeling and itching.
- •Patients with score less than 15mm on Schirmer’s test.
排除标准
- •Age below 30 years and above 70years
- •Patients having corneal ulcers.
- •Patients having congenital absence of meibomian glands.
- •Patients having other eye diseases.
- •Patients having systemic diseases like uncontrolled diabetes mellitus, hypertension.
- •Patients having ocular infections.
结局指标
主要结局
Jeevaniya dravya siddha ghrita Nasya with Netratarpan is significantly effective than carboxy methyl cellulose (o.5%) eye drops in the management of Shushkakshipaka 9Dry Eye Syndrome).
时间窗: follow up on 0th, 7th, 14th, 21st, 42nd day
次要结局
- Jeevaniya dravya siddha ghrita Nasya with Netratarpan is not effective than carboxy methyl cellulose (o.5%) eye drops in the management of Shushkakshipaka 9Dry Eye Syndrome).(follow up on 0th, 7th, 14th, 21st, 42nd day)
研究者
Dr Adarsh Ramkalap Sharma
Ayurved Mahavidyalaya Sion, Maharashtra University of Health Sciences