Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DAS-28 ESR
研究概览
简要总结
Intervention therapy study of moringa oliefera extract on the degree of activity of rheumatoid arthritis patients. The research subjects were patients with rheumatoid arthritis-intervention with moringa oliefera for 30 days.
详细描述
Rheumatoid arthritis is a progressive autoimmune disease. Delay in therapy and delay in remission will result in disability. This study is a randomized clinical trial using a new drug for rheumatoid arthritis, moringa oliefera. The choice of moringa oliefera was due to the ability of moringa oliefera in anti-inflammatory and immunosuppressant terms. This drug has also been proven in experimental studies on rheumatoid arthritis animals. This study with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days.
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
- Double (Participant, Investigator)
盲法说明
The capsule form between the drug and the placebo was the same, there was no drug name label on the drug packaging, and only a number was given on the drug packaging.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA criteria according to the ACR / EULAR 2010
- •Visual analog score of more than three.
排除标准
- •Pregnancy
- •Using Methylprednisolone> 8 mg per day
- •Using NSAIDs
- •Chronic Kidney Disease
- •Diabetes Mellitus
- •Heart Failure
- •Lever disease
研究组 & 干预措施
Moringa Oliefera
Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days.
干预措施: Moringa Oleifera (Drug)
Placebo
Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.
干预措施: Moringa Oleifera (Drug)
结局指标
主要结局
DAS-28 ESR
时间窗: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
DAS-28 CRP
时间窗: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
次要结局
未报告次要终点
研究者
Nurhasan Agung Prabowo
Head of Hospital Research Unit
Universitas Sebelas Maret