A randomized open-label controlled clinical study to evaluate the efficacy of Chandana Anjana and Tila Taila Padabhyanga in the management of Asthenopia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Significant improvement in the signs and symptoms of Asthenopia.
研究概览
简要总结
Asthenopia is defined as a group of symptoms that includes difficulty in focusing, transient blurred vision, dull eye ache, and frontal headache. It also includes other symptoms like dry eye, eye strain, burning sensation, and increased lacrimation.
Asthenopia can occur when the ciliary muscles become tired from the continuous adjustment of the lens to focus on objects at varying distances. This may result from prolonged close-up tasks, extended periods of long-distance viewing, or in individuals with convergence insufficiency, phorias, extraocular muscle imbalances, uncorrected refractive errors, incorrect refractive corrections (particularly for astigmatism), or early presbyopia.
RESEARCH QUESTION:
Whether Chandana Anjana and Tila Taila Padabhyanga is effective in the management of Asthenopia?
HYPOTHESES:
Null Hypothesis (H0): There is no significant difference in the clinical efficacy of Chandana Anjana and Ela Anjana with Tila Taila Padabhyanga in the management of Asthenopia.
Alternative Hypothesis (H1): The efficacy of Chandana Anjana and Tila Taila Padabhyanga is better than Ela Anjana and Tila Taila Padabhyanga in the management of Asthenopia.
Alternative Hypothesis (H2): The efficacy of Ela Anjana and Tila Taila Padabhyanga is better than Chandana Anjana and Tila Taila Padabhyanga in the management of Asthenopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects within the age group between 21 to 40 years irrespective of gender, caste, religion, and socio-economic status.
- •Subjects having at least two symptoms under diagnostic criteria.
- •Subjects having vision as 6/6 or 6/6 blur or N6 or N6 blur up to ± 1D.
- •Subjects willing to participate in the study with informed consent.
排除标准
- •History of any intraocular surgery.
- •Subjects having any ocular trauma.
- •Subjects having any uncontrolled systemic illness that can interfere with the course of disease and treatment.
- •Subjects diagnosed with infective diseases of the eye like Conjunctivitis, Uveitis, Scleritis, Keratitis, Stye, Trachoma, Endophthalmitis, Blepharitis, Retinitis and Dacryocystitis.
- •Subjects having refractive errors due to pathological conditions like Cataracts, Corneal opacity, Keratoconus, and Glaucoma.
- •Pregnant and lactating women.
结局指标
主要结局
Significant improvement in the signs and symptoms of Asthenopia.
时间窗: Pre-treatment: 0th Day | Post Treatment: 8th Day | 1st Follow-up: 15th Day | 2nd Follow-up: 30th Day
次要结局
- Generation of in-depth analyzed data on the different aspects of the disease.(Generation of data on possible adverse drug reaction.)
研究者
Dr Akshat Vashisth
Sri Sri College of Ayurvedic Science and Research Hospital