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临床试验/CTRI/2022/02/040279
CTRI/2022/02/040279已完成2 期

Efficacy of Shunthyadi Aschyotana (Eye Drop) with and without Mahatriphaladi Ghrita Pana (Orally) in the management of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets)- An Open Labelled Randomized Comparative Clinical Trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月5日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets).

研究概览

简要总结

Introduction: Dry eye is not a disease entity, but a symptom complex occurring as a sequela to deficiency or abnormalities of the tear film. One of the causes of Dry Eye is excessive use of computer and Visual Display Terminal (VDT). Dry Eye (Due to excessive use of Visual Display Terminal (VDT) Gadgets) is characterized by symptoms like Dry eyes, Eye strain, Burning sensation in eyes, Foreign body sensation or gritty sensation in the eyes, Itching in eyes, Headache. Prevalence rate of Dry Eye in India (Patients with 4 hour or more of visual display terminal (VDT) usage) is 89.98%. Significance: No remedial measures for the prevention and cure of this pathology prevail in the domain of modern medicine except using ocular surface lubricants, computer glasses and counselling for minimum computer use.Though lubricating drops can reduce the effects of Dry Eye, but doesn’t break the root of pathogenesis of the disease, Ayurveda medicine mainly focus on treating the disease from its root cause. Till now no study was conducted to INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA to assess the efficacy of Shunthyadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana. Hence, a clinical study is proposed to evaluate the efficacy of Shunthyadi Aschyotana topically and Mahatriphaladi Ghrita internally in Dry Eye (Due to excessive use of Visual Display Terminal (VDT) Gadgets). Materials and Methods: Minimum 30 patients will be enrolled on the basis of symptoms of Dryness of Eyes (Vishushkatwa), Eye Strain (Akshi Daurbalya), Foreign body sensation in eyes (Gharsha), Itching in Eyes (Kandu), Burning sensation in eyes ( Daha ), Headache (Shirah Shoola).Group A patients will receive interventions Shunthyadi Aschyotana (Eye drop) and Mahatriphaladi Ghrita (Orally), Group B patients will receive interventions Shunthyadi Aschyotana (Eye drop). Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. Follow up: After completion of therapy, follow up will be done for 1 month to assess the status of patient, where patient will be asked to report fortnightly. Adverse effects: This proposal will be reviewed and approved by I.T.R.A., Institutional Ethics Committee, which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • 1.Patients in the age group 18-50 years irrespective of sex, caste, religion. 2.Patients having minimum three symptoms of Dry Eye (Due to Excessive use of Visual Display Terminal (VDT) Gadgets. 3.Minimum 1 hour exposure to any type of Visual Display Terminal (VDT) like desktop, laptop or mobile screens. 4.Patients having minimum 2 findings of below tests: a.Schirmer strip wetting of between 1-15 mm in 5 minutes Schirmer- I test. b.The appearance of dry spot between 1-15 seconds- Fluorescein Tear Film Break Up Test (F-TBUT). c.Mild to Severe Staining (Superficial to dense staining).
  • Fluorescein Staining. d.Mild to Severe Staining (Dot count 1-30).
  • Rose Bengal Staining (Oxford scheme of scoring).

排除标准

  • 1.Age less than 18 years and more than 50 years.
  • 2.Dry Eye due to any local cause e.g., Allergic Conjunctivitis, Xerosis etc.
  • 3.Dry Eye due to systemic disease like Sjogren’s Syndrome.
  • 4.Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy or any other medication such as Antispasmodic drugs like Atropine that may adversely affect the outcome of the study.
  • 5.Persistent contact lens users.
  • 6.Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and Hypertensive.

结局指标

主要结局

Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets).

时间窗: Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets) within 4-6 weeks.

次要结局

  • Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets)(Relief in Signs and Symptoms of Dry Eye (Due to excessive use of Visual Display Terminal (VDT) gadgets) with in 4-6 weeks.)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital

研究点 (1)

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