Safety of Etoricoxib and Piroxicam oral drugs in Osteoarthritis patients at Rama hospital Kanpur
- Conditions
- Osteoarthritis of knee, unspecified,
- Registration Number
- CTRI/2022/12/047816
- Lead Sponsor
- PRINC BGHEAL
- Brief Summary
**introduction:** Osteoarthritis is a chronic degenerative disorder, which commonly affects the knee joint, and osteoarthritis prevalence is 22% to 39% in India. It is usually associated with aging and most likely affects the joints that are continually stressed throughout the years, including knees, hips, fingers, and lower spine regions. It is one of the ten most disabling diseases in developed countries. Almost 9.6% of men and 18.0% of women aged over 60 years globally have symptomatic osteoarthritis. The goal of osteoarthritis treatment is to reduce pain and improve function, as there is no cure for the disease, but some treatment attempts to slow the disease progression.4 Most often, therapies include physical measures, drug therapy and, sometimes, surgery.
**HYPOTHESIS**
1. Etoricoxib and Piroxicam play a major role in pain associated with patients of osteoarthritis.
2. There is a significant reduction in the intensity of pain in patients with osteoarthritis in the pharmacotherapy of Etoricoxib and Piroxicam.
3. There is a non-significant adverse effect of Etoricoxib and Piroxicam in the pharmacotherapy of osteoarthritis patients.
**Aim and Objectives**
A comparative study to evaluate the safety & efficacy of Etoricoxib and Piroxicam in the pharmacotherapy of Osteoarthritis at tertiary care hospital Kanpur
**Objectives:**
Ø To evaluate the safety & efficacy of Etoricoxib in pharmacotherapy of Osteoarthritis at tertiary care hospital Kanpur.
Ø To evaluate the safety & efficacy of Piroxicam in pharmacotherapy of Osteoarthritis at the tertiary care hospital Kanpur.
Ø To compare the safety & efficacy of Etoricoxib and Piroxicam in pharmacotherapy of Osteoarthritis at tertiary care hospital Kanpur.
**MATERIAL AND METHODS**
The study will be an open-labeled, observational, prospective longitudinal design that will be conducted in the Department of Pharmacology in collaboration with the Department of Orthopedics, Rama Medical College, Hospital & Research Centre Mandhana Kanpur Uttar Pradesh.
Ethical permission will be taken from the Institutional Ethics Committee before starting our study. The patients presenting in OPD of the orthopedic department with knee pain who will fulfill the inclusion criteria and are willing to give written informed consent will be randomized into two study groups -I and II. The patient will be followed up and will be evaluated for the safety & efficacy of the prescribed study drugs, Etoricoxib and Piroxicam.
**Type of study:** The study will be an open-labeled prospective, longitudinal study.
**Study duration: The research** study will be of one-year duration.
**Sampling:** Randomized sampling
**Sample size:** total samplesof290 patients of osteoarthritis.
**Inclusion criteria;**
· Patients with symptomatic osteoarthritis of age 35 to 65 years who fulfill the western Ontario and McMaster universities osteoarthritis index (WOMAC).
· Criterion for the diagnosis of osteoarthritis will be enrolled.
· Patients having symptomatic Osteoarthritis either as a new case or as an old case following discontinuation of treatment with NSAIDs or other analgesic medications with a washout period of one week
· All these patients will be examined as per the baseline criteria and will be included in the study if they fit this criterion.
**Exclusion criteria;**
· Smokers/ alcoholics
· Pregnant & lactating women.
· Patients on steroid therapy, history of chronic infections like TB, leprosy, recent trauma, surgery, mental retardation, minor.
· Patients with liver diseases, kidney diseases, and cardiac problems.
**Materials:**
Osteoarthritis patients
Oral Etoricoxib drugs
Oral Piroxicam drugs
The study also require a detailed history of osteoarthritis patients regarding the socio-demographic profile, present and past health history & its treatments will be recorded after drug therapy: a standard questionnaire will be prepared, and data will be collected on clinical variables likes,
OPD Number
Age
Weight
Height
Duration of osteoarthritis.
Other systemic diseases
**STUDY GROUP**
Group -I: Etoricoxib (60mg) in osteoarthritis.
Group -II: Piroxicam (20mg) in osteoarthritis.
**Follow up:** The patients follow up done 1st – 7days, 2nd -15 days, 3rd – one month
**SAMPLE SIZE CALCULATION & STATISTICAL ANALYSIS**
**SAMPLE SIZE:**
A sample size of 264 was calculated by using the formula. Considering the 10% attrition, a sample of 26 is added and the **sample size is rounded to 290** A total of 290 osteoarthritis patients are selected from Rama Medical College – Hospital & research center, Kanpur will be recruited for the study. formula **n= Z2 X p (1-p) / e2**
Where n= sample size, Z= 95%, the confidence level is 1.96, the population proportion of **0.22, e** for margin of error of 5%.
**METHODOLOGY**
The western Ontario and McMaster university’s osteoarthritis index (WOMAC).
Name:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Instructions: Please rate the activities in each category according to the following
scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely
Circle one number for each activity
Pain 1. Walking 0 1 2 3 4
2. Stair Climbing 0 1 2 3 4
3. Nocturnal 0 1 2 3 4
4. Rest 0 1 2 3 4 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_5. Weight bearing 0 1 2 3 4
Stiffness 1. Morning stiffness 0 1 2 3 4 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Stiffness occurring later in the day 0 1 2 3 4
Physical Function 1. Descending stairs 0 1 2 3 4
2. Ascending stairs 0 1 2 3 4
3. Rising from sitting 0 1 2 3 4
4. Standing 0 1 2 3 4
5. Bending to floor 0 1 2 3 4
6. Walking on flat surface 0 1 2 3 4
7. Getting in / out of car 0 1 2 3 4
8. Going shopping 0 1 2 3 4
9. Putting on socks 0 1 2 3 4
10. Lying in bed 0 1 2 3 4
11. Taking off socks 0 1 2 3 4
12. Rising from bed 0 1 2 3 4
13. Getting in/out of bath 0 1 2 3 4
14. Sitting 0 1 2 3 4
15. Getting on/off toilet 0 1 2 3 4
16. Heavy domestic duties 0 1 2 3 4
17. Light domestic duties 0 1 2 3 4
Total Score: \_\_\_\_\_\_ / 96 = \_\_\_\_\_\_\_% Comments / Interpretation (to be completed by therapist only
§ Patients global impression of improvement (PGI-I)
| | |
| --- | --- |
|Check the number that best describes how your patients conditions is now, compared with now it was before you had taken the drugs.
|Very much better
1
|Much better
2
|A little better
3
|No change
4
|A little worse
5
|Much worse
6
|Very much worse
7
|
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 290
- Patients with symptomatic osteoarthritis of age 35 to 65 years who fulfill the western Ontario and McMaster universities osteoarthritis index (WOMAC) 2.
- Criterion for the diagnosis of osteoarthritis will be enrolled.
- Patients having symptomatic Osteoarthritis either as a new case or as an old case following discontinuation of treatment with NSAIDS or other analgesic medications with a washout period of one week 4.
- All these patients will be examined as per the baseline criteria will be included in the study if they fit this criterion.
- Smokers/ alcoholics 2.
- Pregnant & lactating women.
- Patients on steroid therapy, history of chronic infections like TB, leprosy, recent trauma, surgery, mental retardation, minor.
- Patients with liver diseases, kidney diseases, and cardiac problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain, Stiffness, physical Function - measured with Western Ontario and McMaster Universities Arthritis Index (WOMAC). one month 2. Adverse effects: Total number of adverse effects (all), Gastrointestinal adverse effects (for example, nausea, vomiting), Neurological (nervous system) adverse effects (for example, headache, fatigue, dizziness). one month
- Secondary Outcome Measures
Name Time Method Improvement - measured with a Patient Global Impression Scale of Improvement (PGI) as a quality indicator. one month
Trial Locations
- Locations (1)
RAMA MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE
🇮🇳Nagar, UTTAR PRADESH, India
RAMA MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE🇮🇳Nagar, UTTAR PRADESH, IndiaPRINC BGHEALPrincipal investigator7985112850princebaghel29@gmail.com