Effect of SHATADHOUTA GHRITA topical application in DRY EYE with special reference to the STATUS OF TEAR FILM A randomised open label controlled clinical trail
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SHATADHOUTA GHRITA may show effect in changing the status of Tear Film
研究概览
简要总结
NEED FOR STUDY
Dry eye is Commonest problem encountered in present day due to multiple factors are like Aqueous deficiency defective blinking Vitamin A deficiency It is a situation in which there is inadequate tear volume or unstable tear film due to any other reason Watering in the eye itself is one of the clinical features of Dry Eye Syndrome which is actually reflex watering induced due to dryness This phenomenon keeps the patient away from the doctorand makes the disease chronic In early stages clear watering occurs whereas in due course these secretions become turbid and turns into mucoid with filamental debris As previously mentioned hyperosmolarity is one of the factors contributing to ocular surface inflammation. Hyperosmolarity induces inflammation in human limbal epithelial cells by increasing expression and production of proinflammatory cytokines and chemokines This process appears to be mediated through activation of the cJun Nterminal kinases and MAPK signaling pathways Tear deficiency evaporative troubles, altered food behavioral regimen profession and modified lifestyle contribute a lot for this trouble In modern medicine Dry Eye Syndrome is palliative manageable condition Selection of the particular tear supplement is the only non invasive treatment
There is a need of safe effective short term easily available and that can be done at their own place is required SHATADHOUTA GHRITA topical application is one of such procedure which resembles as modern management and easily acceptable procedure
Considering all above this study is planned to find the effect of SHATADHOUTA GHRITA topical application in dry eye with special referrence to the status of tear film
AIMEffect of SHATADHOUTA GHRITA topical applicationin Dry Eye with special referrence to tear film status
OBJECTIVES PRIMARY To study the effect of SHATADHOUTA GHRITA on specific layers of tear film SECONDARY To study the effect of D Panthenol ophthalmic gel 5 percentage on specific layer of tear film
RESEARCH QUESTION Is SHATADHOUTA GHRITA effective in changing the status of Tear Film in terms of its quantity and qualityHYPOTHESIS H0SHATADHOUTA GHRITA topical application is not effective in DRY EYE with special referrence to Status of Tear Film H1SHATADHOUTA GHRITA topical applicationis effective in DRY EYE with special referrence to status of Tear Film
EXPECTED OUT COMESHATADHOUTA GHRITA may show effect in changing the status of Tear Film
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling the diagnostic criteria of DRY EYE DISEASE that is Schirmer Test and Tear break up time 18 to 40 years of age group Irrespective of gender occupation religion will be included.
排除标准
- •Subjects with diagnosed case of Severe conditions of ocular surface disorders Severe conditions like Steven Johnsons syndrome Chemical Thermal Radiation burns idiopathic atrophy Trachoma Ocular pemphigoid Sjogrens Syndrome Corneal epitheliopathies like Neuroparalytc keratitis post-herpetic or post-measles infection of cornea Conjunctival epitheliopathies like Pterygium or Pseudo-pterygium Tumors Retention cysts chronic low grade bacterial or viral conjunctivitis Lid abnormalities like Meibomitis Blepharitis Facial nerve palsy Lagophthalmos Lacrimal gland diseases like infiltration of gland with sarcoidosis lymphoma leukemia amyloidosis congenital Alacrimia Vitamin A deficiency effect of the drugs like atropine antihistamine diuretics Specific systemic infections like Tuberculosis Leprosy Hypertension RA Diabetes mellitus.
结局指标
主要结局
SHATADHOUTA GHRITA may show effect in changing the status of Tear Film
时间窗: Day 0th before treatment | Day 15th after treatment | Day 21th follow up
次要结局
未报告次要终点
研究者
Dr Rasika Arvind Magdum
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Research center, Shahapur, Belgaum