Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain score 1
研究概览
简要总结
To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).
详细描述
Sample size 66 volunteers
The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No pregnancy
- •No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
- •No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study
排除标准
- •Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
- •Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
- •On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
研究组 & 干预措施
100 mg SHT extract
Drug: Sahastara remedy alcoholic extract comparison with diclofenac
干预措施: Diclofenac (Drug)
25 mg dicolfenac
Drug: diclofenac comparison with diclofenac
干预措施: Sahastara remedy extract (Drug)
结局指标
主要结局
Pain score 1
时间窗: 28 day
Pain score from Visual analog scale
次要结局
- Pain score 2(28 day)
研究者
Mr NARIN KAKATUM
Faculty of Medicine
Thammasat University