Investigating the Efficacy of TCM based Acupuncture and Trataka (yogic practice) for myopia management in female adults a Randomized Controlled Trial
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
- Focal length of the refractive error
研究概览
简要总结
The Randomised Controlled study aims to Investigate the Efficacy of Traditional Chinese Medicine based Acupuncture and Trataka yogic practice for myopia management in female adults The primary objective is to assess the comparison effectiveness of TCM-based acupuncture and Trataka in reducing the progression of myopia in female adults The secondary objective is to assess the safety and tolerability of both TCM based Acupuncture and Trataka as therapeutic modalities in female adults The study will be for 2 months with the sample size of 60 participants The intervention involves session of TCM based Acupuncture for 30 minutes on alternate days for 2 months and points are UB1 UB2 ST1 GB20 GB37 LIV3 LI4 with the usage of stainless scalp needles The comparator agent will be Trataka a yogic practice of whole session is for 30 minutes on alternate days for 2 months The asseesment will be done by Snellen chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire for both the groups The participant withdrawal is allowed at anytime and safety and adverse events will be monitered and reported to the institutional ethical committee
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female adults aged between 18 to 45 years Participants must have been diagnosed with myopia or nearsightedness by a qualified ophthalmologist or optometrist Participants with mild to moderate myopia up to -6.00 diopters will be included Participants with no history of previous eye surgery for myopia correction Participants with stable refractive error over the past six months with no significant changes in prescription Participants capable of understanding the trial procedures and providing informed consent prior to participation.
排除标准
- •Individuals without a confirmed diagnosis of myopia Participants with severe myopia greater than -6.00 diopters or pathological myopia Individuals incapable of understanding the trial procedures or providing informed consent Participants with systemic diseases example diabetes autoimmune disorders that may affect ocular health or study outcomes Participants with a history of previous eye surgery for myopia correction Individuals with a history of significant changes in refractive error within the past six months Participants with severe eye conditions example glaucoma, retinal detachment other than myopia that may confound the study results.
结局指标
主要结局
Focal length of the refractive error
时间窗: Snellen eye chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire will be taken on 0th day and 60th day of intervention
次要结局
- Visual acuity and ocular health and ocular quality of life(Snellen eye chart test and Refractive eye test and National Eye Institute Visual Function Questionnaire will be taken on 0th day and 60th day of intervention)
研究者
Dr Katakam Bhavana
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women