An open label, randomized, two arms trial to evaluate the safety and efficacy of extract of Commiphora myrrha (Myrlimax capsule) in comparison to etoricoxib in patients with arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis.
研究概览
简要总结
Now a days, most people are suffering from arthritis. In arthritis conditions, severe pain will be present. Etoricoxib is one of the drugs used to relieve pain in arthritis patients. Etoricoxib is more effective, but it will cause some ADRs in patients, such as cardiovascular problems and renal and gastrointestinal problems. Myrlimax capsules are also used in the treatment of arthritis patients. It is more effective in reducing pain, and it also has fewer side effects. It has more properties, like being gastroprotective, anti-inflammatory, and analgesic. So in the study, we developed the safety efficacy of myrlimax capsules in comparison with etoricoxib. A total of 30 male and female subjects of age between 40 and 75 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-ggenerated randomization list. The subjects will be assigned to either one of the study groups (myrlimax capsule or etoricoxib). The participants will be instructed to take capsules daily in the morning and evening for 30 days. Apart from primary and secondary outcomes, the study will also record vital signs and adverse events to evaluate herbal composition safety and tolerability. The safety assessment of myrlimax capsules will also include routine laboratory investigations on blood, urine, and clinical chemistry at screening and the final visit of the investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of arthritis rheumatoid arthritis
- •osteoarthritis gout arthritis based on history clinical presentation and radiological findings
- •Minimum VAS 4 on walking in one or both hands or knee during 24 hours preceding requirement
- •Patient ambulant and requiring treatment for arthritis
- •Post operative patients are also eligible
- •Able to give written informed consent form.
排除标准
- •Known history of hypersensitivity to herbal extracts or dietary supplements.
- •Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found to positive for urine pregnancy test.
- •Patient incapacitated or bound to wheelchair or bed and unable to carryout self- care activities.
- •Treatment with intra- articular injection of corticosteroids into knee within 3 months preceding study.
- •Pre- existing or recent onset of demyelinating disorders or type I diabetes.
- •Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine.
- •Evidence of serval renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations.
- •Patient with congestive heart failure.
- •Patient with hypertension
- •Clinically significant untreated hyper-lipidaemia in context of cardiovascular risk
- •History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
- •Ayurvedic formulation or any form of CAM (complimentary alternative medicine) therapy in the preceding 2 months.
- •Non- co- operative attitude of patients
- •Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study.
结局指标
主要结局
To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis.
时间窗: Mean change in WOMAC – total score (Day 0, day 15 and Day 30)
change from baseline to end of the study in scores in simple reaction time
时间窗: Mean change in WOMAC – total score (Day 0, day 15 and Day 30)
次要结局
- 1. Mean change in WOMAC – pain subscale.(2. Mean change in WOMAC – stiffness subscale.)
研究者
Dr Pakanati krishna Sravanth
Aditya multispeciality hospital