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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- VIGNANS FOUNDATION OF SCIENCE, TECHNOLOGY AND RESEARCH
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis.
Time Frame: 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
Time Frame: Mean change in WOMAC – total score (Day 0, day 15 and Day 30)
Secondary Outcomes
- 1. Mean change in WOMAC – pain subscale.(2. Mean change in WOMAC – stiffness subscale.)
Investigators
Dr Pakanati krishna Sravanth
Aditya multispeciality hospital