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临床试验/CTRI/2025/12/099025
CTRI/2025/12/099025尚未招募Phase 3 4

Randomised Open Controlled Clinical Trial To Assess The Efficacy Of Saptamrit Lauha Orally And Haridradivarti Anjana In Timira w.s.r. Myopia

Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月22日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Improvement in Blurred Vision (Avyakta Darshana),Improvement in Diplopia (Dwidha Darshana),Reduction in Headache (Shirobhitapa), Reduction in Eye strain (Netrayasa),Reduction in Glare/Halo (Vihwala Darshana)

研究概览

简要总结

·         Myopia commonly known as short-sightedness, is a type of refractive error and is a cause of visual impairment globally. The condition is increasingly prevalent due to lifestyle factors such as prolonged use of computers, video games and screen exposure. In Ayurveda, Myopia closely resembles to Timira involving the first and second patal based on clinical presentation, anatomical structures and disease pathogenesis.

·      This study aims to evaluate the clinical  efficacy of saptamrit Lauha (oral)  and Haridradivarti anjana (topical) in patients of Timir (Myopia). The study adopts an integrative approach to manage both symptoms and the underlying cause of visual impairment.

A randomised controlled trial will be conducted on 200 patients diagnosed with myopia. Participants will be divided in two groups (n = 100 each). Group A will be treated with Haridradivarti anjana (topical) and Saptamrit Lauha (Orally); while Subjective parameters include - Blurred vision (Avyakta darshan), Diplopia (Dwidha darshan), Headache (Shirobhitap), Eye Strain (Netrayasa), Visual Distortions (Vivhala Darshana). Objective parametrs include Visual Acuity, Autorefractometry, Ophthalmoscopy and A-Scan.

Treatment outcomes will be assessed at regular intervals- on Day 7, 21, 35, 49 and 60. The trial will be conducted at MESAM Parshuram Hospital, Lote, Tal. Khed, Dist. Ratnagiri. Data will be analysed statistically using appropriate methods. Observation and results will be discussed with subject experts, tabulated and conclusions drawn based on evidence obtained.

·

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
15.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients showing symptoms of Timir; Avyakta Darshana, Dwividha Darshana, Shirobhitapa, Netrayasa, Vihwala Darshana
  • Patients are selected irrespective of gender, socioeconomic state.

排除标准

  • Patients not willing for the trial were excluded
  • Patients having corneal opacity, iridocyclitis, infective disease, Traumatic Vision Loss and pathological myopia were excluded.
  • Patients suffering from systemic diseases.

结局指标

主要结局

Improvement in Blurred Vision (Avyakta Darshana),Improvement in Diplopia (Dwidha Darshana),Reduction in Headache (Shirobhitapa), Reduction in Eye strain (Netrayasa),Reduction in Glare/Halo (Vihwala Darshana)

时间窗: Baseline, Week 2, Week 4, Week 6, Week 10

次要结局

未报告次要终点

研究者

发起方
Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Dattatraya Yalagi

Yashwant Ayurvedic College , Kodoli, Dist. Kolhapur

研究点 (1)

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