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临床试验/CTRI/2024/10/074661
CTRI/2024/10/074661尚未招募2 期

Prevalence of Knee Osteoarthritis and Efficacy of Irsal e Alaq (Leech Therapy)in its Management and Potential Role in Improving the Quality of Life:A Hospital Based Study

Jamia Hamdard1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
Jamia Hamdard
入组人数
60
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

This study is Hospital based,Quasi-experimental Trial and conducted on Diagnosed patient of knee O.A. from OPD of Majeedia Unani Hospital subjects fulfilling the inclusion criteria (ACR Diagnostic criteria) and willing participant are to be enrolled in the experimental and control group.Group A (Experimental Group) is receiving "Leech Therapy" along with oral medication Therapy of Habbe Suranjan 2 tablets twice daily for 28 days .Leech therapy will be given for 40 minutes for three sittings i.e. on 1st day,14th day,28th day and Group B (control Group) is receiving standard treatment of Habbe suranjan 2 tablets twice a day for 28 days.Patients will be assessed at the baseline I.e. on day 1 and post treatment at 6 week.The findings will be recorded in Case Record Form designed for the study based on clinical examination, along with subjective and objective parameters.

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
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients fulfilling the ACR diagnostic criteria 2.Diagnosed Patients of Knee OA in age group of 35 to 65 years 3.Clinically Stable Patients 4.Patients of all gender 5.Patients willing to sign the informed consent form and participate in the trial voluntarily.

排除标准

  • 1.Age below 35 and above 65 2.Grade 4 Osteoarthritis in X-ray film(kellgren and Lawrence) 3.Patient on anticoagulant therapy or Hemophiliacs 4.Pregnant women and lactating mothers 5.Subject who are chronically ill patient with infectious diseases 6.Patients who fail to give written consent Patients taking analgesic or anti-inflammatory drugs for any other disease.

结局指标

主要结局

Visual Analogue Scale

时间窗: At baseline i.e day 1 and post treatment at 6th week

WOMAC scale

时间窗: At baseline i.e day 1 and post treatment at 6th week

次要结局

  • SF12v2 Questionnaire (for Quality of Life)(At baseline i.e. day 1 and post treatment at 6th week)

研究者

发起方
Jamia Hamdard
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Fatma Zarrin

Jamia Hamdard

研究点 (1)

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