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临床试验/CTRI/2024/03/064542
CTRI/2024/03/064542尚未招募2/3 期

A Randomized Controlled Trial of effectiveness of Rajanyadi Ksheerpaka Parisheka in comparison with Carboxymethylcellulose Eye Drops in the management of Shushkakshipaka (Dry Eye Syndrome).

Dr Anjali Shelke1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月15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
80
试验地点
1
主要终点
Rajanyadi Ksheerpaka Parisheka is significantly effective in the treatment of Shushkakshipaka (Dry Eye Syndrome) than Carboxymethylcellulose Eye Drops

研究概览

简要总结

Title: A Randomized Controlled Trial of effectiveness of Rajanyadi Ksheerpaka Parisheka in comparison with Carboxymethylcellulose Eye Drops in the management of Shushkakshipaka (Dry Eye Syndrome).

Assessment Criteria:

Selected patients will be treated with Rajanyadi Ksheerpaka Parisheka and grades of symptoms will be noted in each follow up and compared to initial values.

Subjective criteria:

  1. Ruksha vartma grade0 / 1 (Absent/ Present)

  2. Vilokane cha avil darshanam grade0/ 1 (Absent /Present)

  3. photophobia grade 0 /1 (Absent /Present)

  4. Gharsha grade0 /1 (Absent /Present)

  5. Redness grade0 /1 (Absent /Present)

  6. Toda (Pricking Pain) grade0 /1 (Absent /Present)

Objective criteria:

Visual acuity assessed by Snellen’s chart

Dryness of eyes to be assessed by Shirmer’s test, Rose Bengal test, Tear Film break up test

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

入选标准

  • Patient suffering from symptoms of Shushkakshipaka (Netrashushkata, Netra Toda, Vilokane cha Avildarshanam, Gharsha, etc.)
  • Patients age group between 30-50 years irrespective of gender, economical status.
  • Patients with 5 mm- 15 mm on Schirmer’s I test.

排除标准

  • Patients having any ocular infection.
  • Patients having any congenital eye anomaly.
  • Patients having any systemic disorder like diabetes mellitus, hypertension and autoimmune disorders like Sjogren’s syndrome etc.
  • Patients having any corneal pathology.
  • Patients having congenital absence of meibomian glands and other lid disorders.

结局指标

主要结局

Rajanyadi Ksheerpaka Parisheka is significantly effective in the treatment of Shushkakshipaka (Dry Eye Syndrome) than Carboxymethylcellulose Eye Drops

时间窗: follow up on Day 0th, 3rd,7th,14th

次要结局

  • Rajanyadi Ksheerpaka Parisheka is not effective in the treatment of Shushkakshipaka (Dry Eye Syndrome) than Carboxymethylcellulose Eye Drops(follow up on Day 0th, 3rd,7th,14th)

研究者

发起方
Dr Anjali Shelke
申办方类型
Other [Other ( self)]
责任方
Principal Investigator
主要研究者

Dr Anjali Shelke

YMT Ayurvedic Medical College And Hospital

研究点 (1)

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