跳至主要内容
临床试验/CTRI/2021/08/035633
CTRI/2021/08/035633尚未招募2 期

Prevalence of knee osteoarthritis and efficacy of hijamah bila shart in its management: 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: 2021年8月16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 (VAS)

研究概览

简要总结

Besides psychosocial effects of osteoarthritis, the economic burden is extremely high, including direct costs related to drugs, medical care and hospitalization. This burden is largely attributed to the effects of the disability which causes loss of work days and mental stress indirectly. The available treatment options include NSAIDs which havebeen reportedto cause gastropathy, renal and hepatic toxicities, and increasing CVD risk on prolonged use (Goldstein, et al., 2015)

Furthermore, among the chronic rheumatic diseases, knee osteoarthritis (OA) is the most prevalent and is a leading cause of pain and disability in most countries worldwide. Its prevalence increases with age and generally affects women more frequently than men. OA is strongly associated with aging and heavy physical occupational activity, a required livelihood for many people living in rural communities in developing countries. Determining region-specific OA prevalence will provide important information for planning future cost-effective preventive strategies and health care services.

There is no prevalence present about knee osteoarthritis in Unani System of Medicine. Although in Unani Medicine, the effectiveness of Hijama­h-bila-shart (dry cupping) in the management of Knee OA is time tested, however, the data concerning the effectiveness of hijamah-bila-shart (dry cupping) without concurrent use of oral or topical drugs are infrequent. Hence, there is a need to create research-based evidence for validation ofthe effectiveness of Hijama­h-bila-shart and to determine the prevalence of knee osteoarthritis in patients visiting OPD of Ilaj-Bil-Tadbeer in Majeedia Unani Hospital.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Diagnosed patients of knee OA in age groups of 35 to 65 years.
  • •Subjective pain intensity of 5mmto 74mm (mild to moderate pain) baseline on Visual Analogue Scale (VAS).
  • •Grade 2and grade 3 osteoarthritis in X-ray film.
  • (Kellgren and Lawrence) •Clinically stable patients.
  • •ESR<40mm/hr •Rheumatoid factors (RF)<1:40 •Patients of all genders.

排除标准

  • •Age below 35 and above
  • •ESR > 40mm/hr.
  • •Rheumatoid factors (RF)>1:40 •< Grade 2 and >grade 3osteoarthritis in X-ray film.(Kellgren and Lawrence) •Patients with uncontrolled DM, Hepatic, Renal or CVS disorders.
  • •Patient on anticoagulant therapy or Haemophiliacs •Pregnant and lactating mothers.
  • •Subjects who are chronically ill patient with infectious diseases like AIDS and Tuberculosis etc.
  • •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 (VAS)

时间窗: Baseline, 28th day

Knee Injury And Osteoarthritis Outcome Score (KOOS)

时间窗: Baseline, 28th day

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Index (Modified – CRD Pune Version)

时间窗: Baseline, 28th day

次要结局

  • Prevalence of Knee OA in the total number of patients reporting at the registration counter of the Hospital(At the end of three months)

研究者

发起方
Jamia Hamdard
申办方类型
Other [Deemed to be University]

研究点 (1)

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