跳至主要内容
临床试验/CTRI/2025/04/085652
CTRI/2025/04/085652尚未招募4 期

A controlled clinical study to evaluate the effect of Nayanasukhavarti Anjana in prevention of recurrence of Arma (Pterygium) following Arma Chedana.

Dr NITHIN V1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To prevent the recurrence of pterygium

研究概览

简要总结

Arma is one among Shuklagatha Roga which is characterized by gradually spreading fleshy growth occurring in the Shukla mandala. Based on the bheda, varna, and dosha involved, Arma is classified into 5 types i.e., Prastari Arma, Shukla Arma, Kshataja/Lohita Arma, Adhimamsa Arma, and Snayu Arma. The anatomical understanding of the Shukla mandala and the symptoms of Arma suggest a comparison to Pterygium. In contemporary, Pterygium is a wing-shaped fold of conjunctiva encroaching upon the cornea from either side within the interpalpebral fissure. The main treatment for pterygium is surgical removal, which has to be taken into consideration in case of reduced visual acuity due to visual axis involvement, induced astigmatism, or frequent inflammation and discomfort. The prevalence rate of pterygium in the total population of India was 10%.

The treatment principles explained in the classics for Arma, Chedana followed by Lekhana Anjana is considered to be more effective*.* In Chedana procedure the excessive growth in the Shukla mandala is excised. “Nayanasukha varti” a medicine mentioned in the management of Arma in Bhaishajyaratnavali, Contains the Drugs having Lekhana, Chakshushya, Vranaropaka, Rasayana and Tridoshahara Properties.

Pterygium surgery is concerned by postoperative recurrence whose rate can be 24% to 89% and its severity may vary according to the adopted approach and preoperative conditions because fibrovascular growth may occur also with greater extension than its primary presentation. To reduce the recurrence rate advanced techniques have been adopted such as Conjunctival Autografting, Mitomycin C application, and Amniotic membrane graft. Conjunctival limbal autograft (hereafter referred to as "conjunctival autograft") involves removing limbal tissue and adjacent conjunctiva in one piece from another part of the person’s eye and using the tissue to cover the area from which the pterygium was excised. Recurrence of pterygium at three months after surgery ranged up to 16.7% in the conjunctival autograft. The postoperative complications observed included conjunctival encroachment over the graft, small graft, graft dislodging, thick graft, improper position, graft edema, ocular surface exposure, progressive horizontal conjunctivalization, and pyogenic granuloma.

Hence, to overcome the above complications, cost efficiency and effectiveness this study is undertaken to evaluate the effect of Nayanasukha varti Anjana in the prevention of the recurrence of Arma following the arma chedana karma. In this study the control group is conjunctival autografting following Arma Chedana in the prevention of recurrence of Arma.

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
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having either any one of the clinical features of chedana sadya arma such as charmabha bahala snayu mamsaghanaavrutta krushnamandalaga.
  • Controlled diabetic and hypertensive.
  • Patients willing to come for follow up of 6 months.

排除标准

  • Lekhana Sadya Arma.
  • Recurred Pterygium.
  • Subjects having any inflammatory diseases of the eye.
  • Subjects suffering from any of the systemic disorders.
  • Pregnant women and lactating mothers.

结局指标

主要结局

To prevent the recurrence of pterygium

时间窗: 220 days

次要结局

  • Reduction in the redness foreign body sensation and watering of eye(40 days)

研究者

发起方
Dr NITHIN V
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nithin V

Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal

研究点 (1)

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