A Double-blind, Randomized, Parallel Group, Fase III Comparative Study With Rose Hip Powder Powder and Placebo Given to Patients With Mild to Moderate Osteoarthritis in the Knee or/and Hip
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- difference in the effect by using WOMAC-pain score.
研究概览
简要总结
The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.
After the patient has receiving information about the study and after given written informed consent, the patient will be screened. All patients are randomized to receive standardized rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose hip (or placebo) for the remaining 12 weeks of the study.
The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.
Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks of treatment, subjects will be asked about how things are going and to remember to take the capsules and whether they have completed the diary.
The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the questionnaires including VAS scales.
The last patient visit will take place after 12 weeks. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 40 + years
- •Osteoarthritis symptoms with duration of more than 6 months
- •One WOMAC-pain visual analogue scale score (VAS score) there are at least 35 mm at rest
- •Subjective morning joint stiffness
- •Clinical symptoms of arthritis diagnosed by the ACR (American College Rheumatology) criteria
排除标准
- •Patients who have been treated with rose hip extracts or powder within 3 months before screening.
- •Patients who have been treated with ginger, avocado or soybean extracts or powder within 3 months before screening
- •Patients on steroids, TNFalpha or DMARD prior to trial.
- •Patients receiving irregular medical treatment for osteoarthritis.
- •Patients suffering from other joint diseases other than osteoarthritis.
- •Patients who abuse alcohol
- •Patients with a current psychiatric illness, drug and / or alcohol abuse
- •Patients with known allergy to rose hips
- •Presence of other clinically significant medical conditions
- •Patients scheduled for joint or major surgery during the trial.
- •Patients participating in another clinical trial, or have participated in another clinical trial within 3 months before this study.
- •Patients with known compliance problems or who are uncooperative.
- •Pregnant or lactating women.
结局指标
主要结局
difference in the effect by using WOMAC-pain score.
时间窗: 12 weeks
The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-pain scores at 3 months of treatment between active treatment and placebo group, and between baseline and 3 months.
difference in the effect by using WOMAC-ADL score
时间窗: 12 weeks
The effect of treatment within each of the two groups (Rose hip powder and placebo) measured by using the differences in WOMAC-ADL (Activities of Daily Living) scores at 3 months of treatment between active treatment and placebo group, and between baseline and 3 months.
次要结局
- Quality of life(12 weeks)
- Difference in the effect by using WOMAC-pain score(6 weeks)
- Patient assessment of the disease(12 weeks)
- difference in the effect by using WOMAC-ADL (Activities of Daily Living)score(6 weeks)