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临床试验/CTRI/2025/11/097338
CTRI/2025/11/097338尚未招募2 期

Y-PRP Trial : Yoga enhanced PRP vs Conventional PRP- Growth factor assessment and functional outcomes in early knee osteoarthritis

CCRYN1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
CCRYN
入组人数
80
试验地点
1
主要终点
To study the effect of specific yoga protocol on the cell count & growth factor yield of PRP

研究概览

简要总结

Patients presenting with symptoms of knee pain, crepitus, and/or stiffness will be assessed and recruited in the Orthopaedics OPD in PGIMER. A detailed history, general health check-up and a clinical examination of the knee will be performed for each subject to make a differential diagnosis. This examination will include a general physical examination, knee examination, and x-ray of both knees to confirm the diagnosis of OA. The x-rays will be taken in two orthogonal views: a standing anteroposterior and a 30-60° accurate lateral view, through a digital radiographic machine and print on a standard x-ray film will be taken for analysis and grading of OA. Patients with symptomatic KL grade 1 or 2 knee OA fulfilling the inclusion criteria will be recruited for the study after taking written informed consent. All patients will be assessed for pain, stiffness, and functional status using a validated score for knee OA i.e. Western Ontario and McMaster Universities Arthritis Index Questionnaire (WOMAC) score29. Pain in the affected knee joint will be assessed using the Visual Analog Scale(VAS)30. Psychological Scoring will also be done using DASS 2131 Scale to rule out any distress or anxiety-related factors which may affect patient satisfaction after the injection.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • Symptomatic Primary OA Knee OA classified as Grade 1 & 2 who have responded to conservative treatment for 6 months.

排除标准

  • Secondary OA Grade 3& 4 OA immunocompromised status or uncontrolled diabetes bronchial Asthma or known cardiac disease Symptomatic OA affecting joint other than knees Recent 6 month intra articular steroids anti coagulation therapy active or previous infections unwilling to follow exercise protocol/ not consenting for intervention.

结局指标

主要结局

To study the effect of specific yoga protocol on the cell count & growth factor yield of PRP

时间窗: Check whether PRP has better Growth Factor post yoga therapy

次要结局

  • To compare functional outcomes in terms of WOMAC, VAS, DASS 21 score between conventional & yoga enhanced PRP(At 6 weeks, 3 months & 6 months)

研究者

发起方
CCRYN
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sandeep Patel

PGIMER

研究点 (1)

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