CTRI/2024/02/063276尚未招募2/3 期
Combination of Sun Gazing and Acupuncture for Myopia - A Pilot Randomized Controlled Trial
Dr Jyothi KV1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1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
- 60
- 试验地点
- 1
- 主要终点
- 1. measure the changes in the diopter
研究概览
简要总结
- Myopia is defined as a “refractive error in which rays of light entering the eye parallel to the optic axis are brought to a focus in front of the retina when ocular accommodation is relaxed.
- Myopia is commonly seen in younger population with an estimated global prevalence of myopia is increasing by nearly 25%
- Naturopathic medicine is defined “as a drugless, non-invasive, rational and evidence-based system of medicine imparting treatments with natural elements based on the theories of vitality, toxemia and the self-healing capacity of the body, as well as the principles of healthy living.
- Heliotherapy is one of the important treatment modalities used in naturopathic medicine. Sun therapy, also known as heliotherapy is a process of exposing the body to sun light.
- Sun gazing is a technique where the individual is gazing at the non harmful rays of the sun for a specified time.
- Acupuncture a form of complementary medicine in which fine needles are inserted in the skin at specific points along what are considered to be lines of energy, used in the treatment of various physical and mental conditions.
- A Pilot Randomized Controlled Trail for a period of 30 days with a sample size 60 subjects 30 participants in each group.
- Grouping will be randomized in to experimental and control group with an allocation ration of 1:1
- The experimental group will be receiving the intervention i.e., sun gazing and acupuncture for 15 days each respectively while the control group will be receiving acupuncture as intervention for 15 days
- Pre and post assessment of the subjects using Auto refractometer for diopter measurement and Snellens chart for visual acuity will be done.
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
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Age -18 to 25 years.
- •Both Male and Female patients who are pre-diagnosed mild to moderate myopia (0 D to −6.0 D)
- •Subjects who are willing to participate in the study by signing an appraised consent form.
排除标准
- •Subjects who have known allergic reactions to sun exposure
- •subjects with diopter measurement less than -0.6 D
- •Subjects with pathologic myopia related fundus changes or significant vision loss
- •subjects with any other eye related diseases other than myopia
- •those who have history of psychiatric lenses.
结局指标
主要结局
1. measure the changes in the diopter
时间窗: assessment done at two time points | 1. Pre assessment: Day 0 before intervention | 2. Post assessment : Day 30 | after intervention
次要结局
- 1. To measure visual acuity(assessment done at two time points)
研究者
Dr Jyothi KV
Alvas College of Naturopathy and Yogic Sciences
研究点 (1)
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