Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

Etiology:

Classification of knee OA is divided into primary and secondary,depending on the cause. Primary knee OA results from articular cartilage degeneration,the exact cause of which is still unknown, presumably due to increasing age. Secondary knee OA results from articular cartilage degeneration with known causes, including post-traumatic,congenital, or limb malformations,malposition (varus/valgus), scoliosis, rachitis, Wilson’s disease, gout,pseudogout, rheumatoid arthritis, hemophilia, and Paget’s disease.

Risk Factors of Knee osteoarthritis :

Modifiable

a. Articular trauma

b.Occupation – prolonged standing and repetitive knee bending

c.Muscle weakness or imbalance

d.Weight

e.Health – metabolic syndrome

Non-modifiable

a.Gender - females more common than males

b.Age

c.Genetics

d.Race

Epidemiology:Depending on the source, roughly 13% of women and 10% of men 60 years and older have symptomatic knee osteoarthritis. Among those older than 70 years of age, the prevalence rises to as high as 40%.The prevalence of knee osteoarthritis in males is also lower than in females.

Study population-Patient from geriatric age group 65 years and above suffering from Knee Osteoarthritis from Institute/Research centre OPD

Methods of selection of study subjects

I.Inclusion criteria:

1. Clinically diagnosed patients of unilateral or bilateral knee osteoarthritis.

2. Patients of all genders.

3. Patients of age group 65 years and above. 

4. Patients with or without comorbidities.

5. Patients should have history of symptomatic knee osteoarthritis for at least 6 months.

II.Exclusion criteria:

1. Non ambulatory patient.

2. Patient with suspected immune compromised condition.

3. Recent surgical intervention performed on knee joint within 12 months.

4.Patients with organ failure

5.Patients on any other medication of knee

III.Patient withdrawl criteria

1. Patients not coming for regular follow up.

2. Patients who withdraw their consent from the study.

3. Medical and surgical emergency intervention during study.

4. If the WOMAC scale score doesn’t improve in 4 months of treatment.

Sampling technique- Simple random sampling based on inclusion and exclusion criteria.

Data collection methods-

1.Written Informed Consent will be taken in patient local vernacular language and also approved by Institutional Ethical committee

2. The detailed homoeopathic case-taking will be carried out.

3. Appropriate reference book like Homoeopathic Materia Medica, Medicine books, Rheumatology books, Pathology books, different Homoeopathic journals, research paper will be considered.

4. Appropriate software will be used for reportorization of case

Data collection instrument-

1. Written Informed Consent Form.

2. Standardized Case Record.

3.WOMAC scale scores 

Statistical analysis-Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) & percentage (%) of categorical data,mean & Standard deviation of numerical data in each group / subgroup will be depicted.Frequency (n)& percentage (%) of various categories in each group/Subgroup will be compared using chi square test. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non-parametric substitute like Mann Whitney U test will be used. Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. Frequency (n) & percentage (%) of various responses in each time interval will be compared using chi square test / Mc Nemar’s test. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p< 0.05 will be considered statistically significant.