Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
None listed
Sponsors
Ved Sanjeevani Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must satisfy ALL of the following criteria 1 Adults of either sex aged 18 to 70 years inclusive 2 Clinically confirmed diagnosis of Sandhivata Osteoarthritis of a single joint monoarthritis supported by clinical examination and Xray findings 3 VAS pain score mild to moderate 4 Willingness and ability to communicate adequately with the investigator and comply with all protocol requirements including followup visits 5 Freely willing to provide written informed consent prior to any study related procedure 6 Capable of self-administering the study product with supervision or capable of receiving supervised administration at the study site 7 Agreement to refrain from use of any other topical analgesic or anti-inflammatory agent on the same area during the study except permitted rescue analgesic
Exclusion criteria
Exclusion criteria: Subjects will be excluded if ANY of the following conditions are present 8 severe pain requiring more intensive pharmacological management beyond the scope of this trial 9 Multiple joint osteoarthritis or open fractures requiring acute surgical intervention 10 Pregnant women lactating mothers or women of childbearing potential not using reliable contraception 11 Age below 18 years or above 70 years 12 Diagnosed systemic disorders including Diabetes Mellitus active malignancy or immunocompromised states HIV organ transplant recipients systemic corticosteroid use 13 History of thyroid dysfunction or primary calcium/phosphorus metabolism disorders 14 Current use of systemic steroids oral contraceptive pills or any Disease Modifying Antirheumatic Drug 15 Known allergy or hypersensitivity to any component of the investigational product Ashwagandha Guggulu sesame oil or coconut oil 16 Skin lesions active dermatitis umbilical hernia or abdominal wall infection at the Nabhi application site 17 Patients requiring joint replacement surgery or any intraarticular injection within the previous 3 months 18 Non cooperative patients or those unlikely to comply with the protocol 19 Participation in any other clinical trial within the previous 3 months 20 Significant hepatic or renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Visual Analogue Scale Timepoint: BASE LINE DAY 10 DAY 20 DAY 30 DAY FU 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tenderness Hutchinsons Scale Joint Stiffness Grading Deformity Crepitus Timepoint: BASE LINE DAY 10 DAY 20 DAY 30 DAY FU 60 | — |
Countries
India
Contacts
Public ContactDr Pawan Lekurwale
L N Ayurved College and Hospital Bhopal
Outcome results
None listed