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临床试验/CTRI/2020/03/024341
CTRI/2020/03/024341尚未招募2 期

A Randomized Open Label Clinical Trial On the efficacy of Tiktaka Ghrita Tarpana, Prasadana Putapaka And Kataka Khadiradi Ghan Vati In Madumehajanya Timira With Special Reference To Diabetic Retinopathy

Director National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Changes in Diabetic Retinopathy signs and symptoms as Blurred vision, Floaters and etc

研究概览

简要总结

This trial will be done to evaluate clinical efficacy of Kataka Khadiradi kashaya which has mentioned for all types of Prameha.  In order to make it palatable and easy to administer the same kashaya is made in the form of Ghan vati in the dose of 500 mg orally to control madhumeha which is the primary disease.

Hence in one group only oral medicine, Kataka Khadiradi Ghan Vatiis advised to prove the efficacy of oral therapy

The second group will be given  Kataka Khadiradi Ghan Vati along with Tarpana a local treatment with Tiktaka Ghrita.

Third group will be given  Kataka Khadiradi Ghan Vatialong with Tarpanaa local treatment with Tiktaka Ghrita and Prasadana Putapaka to show the significant effect of KriyaKalpa procedures.

1 month research and 1 month follow up after treatment will be done within 15 days gap

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Known cases of Type I and Type II diabetes mellitus
  • Patients with well controlled blood sugar level
  • Patients with visual symptoms like blurring of vision, floaters etc
  • Patients with mild to moderate NPDR
  • Patients willing to give written consent.

排除标准

  • Patients with severe NPDR or with PDR, Diabetic Maculopathy.
  • Patients with Diabetic Retinopathy with complications like Retinal detachment, posterior vitreal detachment, acute vitreal hemorrhage, RubiosisIridis.
  • Gestational Diabetic Retinopathy.
  • Severe visual impairments like high Myopia, Retinitis Pigmentosa, mature Cataract, post Cataract surgeries, Glaucoma.
  • Patients with other systemic complaints like Hypertension, Renal impairment, COPD, cardiovascular diseases.

结局指标

主要结局

Changes in Diabetic Retinopathy signs and symptoms as Blurred vision, Floaters and etc

时间窗: 2 Month

次要结局

  • Procedures might show effect in headache, other eye problems such as Dry eye, Occular Stress, Concretions hence any associated incidental findings if found will be reported.(2 month)

研究者

发起方
Director National Institute of Ayurveda
申办方类型
Government medical college

研究点 (1)

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