CTRI/2023/05/052848已完成不适用
“A COMPARATIVE STUDY TO ASSESS THE EFFECT OF PREGABALIN AND DULOXETINE MEDICATION IN PATIENTS SUFFERING FROM PRIMARY KNEE OSTEOARTHRITIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Percentage of patients with Improvement of 20 % in WOMAC and ICOAP with treatment
研究概览
简要总结
The aim of the present study was to investigate the efficacy of Pregabalin and Duloxetine in reducing pain in older adults with knee OA.Primary knee OA cases are to be selected according to inclusion criteria and matched controls will be selected from family members or relatives.
The patients who failed to get benefit from conventional physical and pharmacological therapy will be offered experimental therapy in this study. informed consent will be taken from the patients.
Then patients will be randomly allocated for pregabalin, Duloxetine and placebo – 3 groups.
They will be followed for six months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with American College of Rheumatology clinical and radiographic criteria of primary knee OA with evidence of inflammation (pain and swelling with decreased function).
- •Disease activity: WOMAC score more than 10 with radiological score of KL 2 & 3.
排除标准
- •Secondary arthritis.
- •Any Comorbidities except controlled DM , HTN , Hypothyroid , dyslipidemias History of taking antiepileptic medication Nonambulatory Patients who have psychiatric disorders, including major depressive disorder known hypersensitivity to Duloxetine / pregabalin or any of the inactive ingredients, or frequent or severe allergic reactions to multiple medications.
- •Pregnant or breast feeding females Women of child-bearing potential not using highly effective contraception.
- •Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ.
结局指标
主要结局
Percentage of patients with Improvement of 20 % in WOMAC and ICOAP with treatment
时间窗: at baseline , 3 months and 6 months
次要结局
- Correlation of icoap in Indian patients in comparison to womac
研究者
研究点 (1)
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