CTRI/2025/08/093408尚未招募不适用
Efficacy and Safety of Metformin (1000 mg/d) as Adjuvant to Standard of Care (SOC) in Management of Mild to Moderate Osteoarthritis (OA) of Knee: A Prospective, Randomized, Comparative Study
D.Y. PATIL Deemed to be University School of Medicine, Navi Mumbai1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain severity from baseline, measured using the pain subscale of the Oxford Knee Score (OKS), in participants with mild to moderate knee osteoarthritis receiving the intervention.
研究概览
简要总结
Protocol:For continuous variables number of non-missing observations (n), mean, standard deviation (SD), median, maximum, and minimum (range) will be presented.For discrete and categorical variables, data will be expressed as numbers with percent values.
All analyses will be done using two-sided tests at alpha 0.05 (95% confidence level).
Study hypothesis:H0: There is no significant difference in the change in OKS scores between the study treatment (Metformin) and the reference (No metformin) treatment.
H1: The change (improvement) in OKS scores is greater with the study treatment (Metformin) and reference (No metformin) treatment.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged between 30 to 70 years.
- •Clinically diagnosed and radiologically confirmed mild to moderate (Kellgren Lawrence grade II and III) symptomatic cases of Osteoarthritis of the knee joints.
- •Onset of symptom duration greater than or equal to 6 months at the time of screening.
- •Greater than or equal to 5 score on a 10-point visual analogue scale (VAS) for pain at baseline.
- •Willing to give consent for participating in the study.
排除标准
- •Patients having severe (Kellgren lawrence grade IV)/ disabling arthritis in the targeted or contralateral knee joint.
- •Patients with radiologically abnormal knee alignment.
- •Those who are suffering from skin-related problems at the local sites of drug application, which may be affected the drug application.
- •Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months.
- •Participants with a history or presence of Type 1 and Type 2 diabetes.
- •Those who are on treatment with immunosuppressive drugs and biologicals
- •Participants who are taking any other oral hypoglycaemic drugs.
- •8.Participants who are taking metformin for any other indication.
- •Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhea, and flatulence Vitamin B12 deficiency.
- •Pregnant and lactating women
- •Any condition which, in the opinion of investigator, will place the subject at risk or will influence the conduct of study or interpretation of results
- •Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL)
- •Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug 14.Patient on systemic corticosteroid therapy
- •Known case of history of allergy with NSAIDs or test drug.
- •Participants who have enrolled in any other trial in the past 6 months.
结局指标
主要结局
Change in pain severity from baseline, measured using the pain subscale of the Oxford Knee Score (OKS), in participants with mild to moderate knee osteoarthritis receiving the intervention.
时间窗: Pain assessment using OKS at Week 1, Week 2, Week 3, and Week 4 following initiation of intervention.
次要结局
- Change in range of motion (ROM) of the affected knee joint from baseline, measured using goniometry.(Change in pain intensity from baseline, assessed using the 10-point Visual Analogue Scale (VAS).)
研究者
Dr Sachin Kale
DY Patil deemed to be University School of Medicine, Navi Mumbai
研究点 (1)
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