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临床试验/CTRI/2025/09/094472
CTRI/2025/09/094472尚未招募2 期

Comparative Clinical Evaluation of Patoladi Ghrita and Saptamrit Lauha in Dwitiya Patalgata Timir (Presbyopia)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月20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
60
试验地点
1
主要终点
1. Blurring of near Vision (Drishtibhrishm Vihvlati)

研究概览

简要总结

This study is a Comparative Clinical Evaluation of Patoladi Ghrita and Saptamrit Lauha in Dwitiya Patalgata Timir (Presbyopia) .

This will be conducted on 60 randomly selected patients from OPD/IPD of Shalakya- Tantra Department of Patanjali Bhartiya Ayurvigyan

Evam Anusandhan Sansthan, Haridwar. Patient will be divided into two groups- 30 patients will be administered with Patoladi Ghrita orally with warm milk or warm water for 60 days and 30 patients will be administered with Saptamrit Lauha orally with madhu and go ghrita for 60 days. First follow up will be after 15 days of treatment and second follow up will be after 15 days of first follow up. Assesment will be done on the basis of subjective and objective parameters as discussed earlier.

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

入选标准

  • Patients between the age group of 35 years to 60 years of either sex.
  • Patients presenting with classical signs and symptoms of Dwitiya Patalagata Timir (Presbyopia).
  • Presbyopic patients associated with refractive error of:- less than -3.00D spherical or cylindrical.
  • less than +3.00D spherical or cylindrical.
  • Patients willing to undergo trial.

排除标准

  • Patients below 35 year and above 60 years of age.
  • Patients suffering with serious systemic metabolic disorder like; Tuberculosis, Diabetes, Hypertension etc.
  • Patients having complaints of acute / chronic infections of lid, conjunctiva, uveitis, glaucoma, cataract, corneal opacity or any other retinal degenerative conditions.
  • Patients associated with general debility, anaemia and malnutrition.
  • Person having excessive close work undertaken in unfavourable surroundings.
  • Patients not willing to undergo trial.

结局指标

主要结局

1. Blurring of near Vision (Drishtibhrishm Vihvlati)

时间窗: 0,10 weeks,12 weeks

2. Eye strain (Netrayasa)

时间窗: 0,10 weeks,12 weeks

3. Headache (Shiroabhitapa)

时间窗: 0,10 weeks,12 weeks

次要结局

  • 1. Near visual acuity (ETDRS Chart/ Log MAR Chart)(2. Near Point Assessment by RAF Ruler (Royal Air Force))

研究者

发起方
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Devinder

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan

研究点 (1)

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