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临床试验/CTRI/2025/06/089354
CTRI/2025/06/089354尚未招募不适用

Effectiveness Of Selected Ayurveda Treatment Protocol In Improving Visual Acuity In Dry Age-Related Macular Degeneration

Anjana Saji1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Improvement In Visual Acuity - Log MAR chart

研究概览

简要总结

Age-related macular degeneration (ARMD) is a degenerative disorder affecting the macula, characterized by the presence of specific clinical findings, including drusen and RPE changes, in the absence of another disorder. Heredity, nutrition, smoking, hypertension, exposure to sunlight, hyperopia, and cataract particularly nuclear opacity have been proposed as risk factors in the pathogenesis of ARMD. Common visual complaints of Dry-ARMD are mild to moderate gradual loss of vision, distorted vision, seeing straight lines as wavy, bent, or fuzzy, and difficulty in near work due to central shadowing. Current treatments include Vitamin, antioxidant supplementation, intravitreal injection & photocoagulation. In Ayurveda, it can be taken as the saadam of darsanendriya resulting from the depletion of dhatus in old age. The gradual progressive painless loss of vision is the characteristic feature of pathology found in timira, kacha, linganasa. The pathogenesis of Dry-ARMD suggests the involvement of Tridoshas predominantly Kapha- Vata dosha. Thus, the basic treatment strategy adopted should be kapha vata samana, sodhana of excess meda kapha, Chakshushya and Rasayana. Anjanam & nasyam are mentioned for samanya thimira chikilsa in Ashtanga Hrdaya Uttara Sthana. Patients within the age group of 50 to 70 years diagnosed with Dry-ARMD will be selected based on inclusion criteria, attending OPD and IPD of Shalakyatantra, Govt. Ayurveda College, Thiruvananthapuram will be subjected to Rasakadi Churnanjanam, Bhringaraja Taila Prathimarsa nasya , and internal administration of Amalaka Rasayana for 3 months. Clinical evaluation and investigations will be done before the commencement of interventions and 3 months after treatment & follow-up will be done 1 month after that. Results will be statistically analyzed after the study by one-way ANOVA test.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)

入选标准

  • Clinically Diagnosed Participants Of Dry-ARMD With Blurring Of Vision, Distorted Vision, Scotoma, And Metamorphopsia.
  • Participants Between The Age Group Of 50-70 Years Irrespective Of Gender, Religion, And Socioeconomic Status.
  • Participants With Visual Acuity Of 6/9 to 6/60(Log mar 0.2-1.00).Participants With Written Informed Consent.

排除标准

  • A)Uncontrolled Hypertension Or Diabetes B) Participants With Mature Cataract, High Myopia, Glaucoma, Other Retinal Degenerations C) Participants With Systemic Illness Like Hypercholesteremia, Liver Disease, Renal Disease D) Pigment Epithelium Detachment E) Participants Who Are Not Co-operative F) Participants With Any Other Macular Disease That Can Superimpose With ARMD G) Participants Who Are Contraindicated For Prathimarsa Nasya.

结局指标

主要结局

Improvement In Visual Acuity - Log MAR chart

时间窗: 3 Months

次要结局

  • 1. Amsler grid examination(2.Changes in the fundus)

研究者

发起方
Anjana Saji
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjana Saji

Government Ayurveda College, Trivandrum

研究点 (1)

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