Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Emami Limited, Kolkatta
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of either sex, between 21 years to 65 years of age. 2. Patients suffering from at least three symptoms of Sandhigatavata with score of 4 or more on the Visual Analogue Score (VAS) 3. Sandhishula (Musculoskeletal Joint Pain) 4. Sandhishotha (Swelling) 5. Stabdhta ( Stiffness) 6. Vatapurna dratisparsha (Tenderness) 7 .Prasarana kunchan pravriti ((Pain during extension and flexion of joints)) 8. Sandhi Sputana/ Atopa (crepitus in a joint) 9 .Participants willing to give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Age below 21 years and above 65 years 2. Participants with acute muscle spasms who need parenteral therapy, urgery or hospital admission for management. Painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. 3. Participants having history of Blood and lymphatic system disorder, cardiac disorder apart from hypertension, congenital familial and genetic disorder, immune system disorder, neoplasms benign, malignant and unspecified disorder, psychiatric disorder, Renal, urinary disorder and autoimmune diseases or an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study. 4. Participants with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg). 5. Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study. 6. Worst possible pain, Inflammation, Stiffness, requiring immediate medical intervention 7. Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding or Scheduled elective surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety & efficacy of Zandu Rhumayog Forte in comparison of Zandu Rhumayog Gold followed by Rhumayog Forte in the management of symptoms associated with Sandhigatavata (osteoarthritis).Timepoint: Baseline, 15th day, 30th Day, 60th Day , 75th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| To validate the clinical efficacy of Zandu Rhumayog Gold & Zandu Rhumayog Forte on the basis of scientific parameters in the patients suffering from Sandhigatavata (osteoarthritis) Timepoint: Baseline, 15th day, 30th Day, 60th Day , 75th Day;To evaluate the safety of Zandu Rhumayog Gold & Zandu Rhumayog Forte in patients suffering from Sandhigatavata (osteoarthritis) Timepoint: Baseline, 15th day, 30th Day, 60th Day , 75th Day | — |
Countries
India
Contacts
Public ContactK RAMACHANDRA REDDY
MGG AYUSH UNIVERSITY, GORAKHPUR
Outcome results
None listed