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临床试验/CTRI/2024/12/077658
CTRI/2024/12/077658尚未招募2/3 期

Randomized control trial of Triphala Ghrita Tarpana versus Carboxymethylcellulose eye drop in Shushkakshipaka (Evaporative Dry eye due to Meibomian Gland Dysfunction): A Pilot study

Ayushi Lohi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月27日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Improvements in Tear film stability

研究概览

简要总结

This study is a Randomized control trial of Triphala Ghrita Tarpanaversus Carboxymethylcellulose eye drop in Shushkakshipaka (Evaporative Dry eye due to Meibomian Gland Dysfunction): A Pilot study. The trial drug Triphala Ghrita Tarpana will be used topically for 10 minutes for 7 days, and the control drug Carboxymethylcellulose eye drop 0.5% will be used topically withone drop four times a day for 7 days. The primary outcome will be an improvement in tear film stability in 7 days, and the secondary outcome will be an improvement in the ocular surface disease index (OSDI) in 7 days, which will be measured before and after the completion of the treatment duration.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Ocular surface disease index (OSDI) greater than and equal to 13 including lid margin changes and decreased meibum quality and quantity, irrespective of sex caste religion and socioeconomic status Participants of both genders aged between 20 and 60 years Tear film break-up time less than 10 seconds Schirmer-I test less than 10 mm.

排除标准

  • Active ocular infection ocular inflammatory disease or aqueous-deficient dry eye Schirmer test value of less than 5 mm.

结局指标

主要结局

Improvements in Tear film stability

时间窗: Improvements in Tear film stability in 7 days

次要结局

  • Improvement in Ocular Surface Disease Index (OSDI)(Improvement in Ocular Surface Disease Index (OSDI) in 7 days)

研究者

发起方
Ayushi Lohi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ayushi Lohi

MGACH AND RC SALOD WARDHA

研究点 (1)

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