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临床试验/CTRI/2025/11/097210
CTRI/2025/11/097210尚未招募不适用

Effect of Topical Application of Jeevaneeya gana ghritha in mild and moderate Dry eye disease - A pre and post interventional study

Dr A G Adithi1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1.OSDI Score

研究概览

简要总结

According to Tear Film and Ocular Surface Society Dry Eye Workshop 2 “Dry eye is a multifactorial disease of the ocular surface characterized by 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”. Dry eye may be corelated with Sushkakshipaka, a Sarvagatha netra roga, which is Vataor Vata Pitha predominant, where Jeevaneeya gana4 is said to be effective. Jeevaneeya gana ghritha will be administered in participants diagnosed with mild and moderate dry eye disease in the age group 20 to 50 years fulfilling the inclusion criteria selected from Shalakyatathra outpatient department of Government Ayurveda College, Kannur. Assessment parameters like Ocular Surface Disease Index (OSDI) score, Schirmer I score and Tear film break up time will be noted and data collected using a case proforma. Participants will be instructed to instil 2 drops of Jeevaneeya gana ghritha at night for a period of 21 days. Post assessment will be done on 22nd, 29th and 36th day of treatment. Results will be statistically analysed with Friedman’s test, Repeated Measures of Anova and Descriptive statistics.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects diagnosed with mild and moderate dry eye disease assessed using any one of the following (i)OSDI Score.
  • Greater than 13 (ii)Schirmer 1 Score.
  • 5mm to 10mm 2.Subjects who are willing to give written informed consent.

排除标准

  • 1.Subjects suffering from other ocular diseases 2.Sjogren’s syndrome 3.Subjects who have undergone ophthalmic surgeries 4.Associated with diabetes mellitus, chronic liver diseases, endocrine diseases 5.Already undergoing topical medications for other ocular pathologies or with history of use of drugs like steroid.
  • 6.Subjects using contact lenses 7.Pregnant and lactating women.

结局指标

主要结局

1.OSDI Score

时间窗: 0th, 22nd, 29th and 36th day

2.Schirmer 1 Score

时间窗: 0th, 22nd, 29th and 36th day

3.Tear Film Breakup Time

时间窗: 0th, 22nd, 29th and 36th day

次要结局

未报告次要终点

研究者

发起方
Dr A G Adithi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

A G ADITHI

Government Ayurveda College, Kannur

研究点 (1)

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