A randomized Double blind placebo controlled trial to check Efficacy and tolerability of LCOX- an herbal formulation in osteoarthritis of Knee.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- difference between WOMAC score in two groups
研究概览
简要总结
This study is a randomized double blind parallel group placebo controlled study, this study is aimed to check efficacy and tolerability of Lcox tablets in knee osteoarthritis patients of either sexes. Lcox is FDA approved polyherbal formulation of Pharmanza Herbal Pvt. Ltd. Each tablet of Lcox contains
-
Shallaki (BoswelliaSerrata) 300mg
-
Ashwagandha (WithaniaSomnifera) 100mg
-
Hadjod (Cissusquadrangularis) 100mgfrom
2 Lcox tablets twice a day will be given to patient in trial group of fifty patients. 2 placebo tablets twice a day will be given to patients in placebo group. treatment will be continue for 2 months for each patient and monthly assessment will be done using WOMAC scale. Data will be recorded and will be used to publish in peer reviewed journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 16.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinico-radiologically diagnosed patients of OA knee b.
- •Patients willing to participate and give signed informed consent c.
- •Either gender d.
- •Age >40 years.
排除标准
- •History of peptic ulcer, acid peptic disease or any other concurrent illness b.
- •End organ damage.
- •RFT, LFT will be conducted pre and post session.
- •Chronic smoker/ alcoholic e.
- •History of allergy against herbal products or NSAIDs f.
- •Subjects who cannot be relied upon to comply with instructions g.
- •Pregnant or breast feeding women h.
- •Gouty Arthritis, Rheumatoid Arthritis, Psoriatic arthritis.
结局指标
主要结局
difference between WOMAC score in two groups
时间窗: at baseline after one month after second month
次要结局
- decrease in level of CTX2 in urine samples of two groups.(at baseline and after second month)