Effect of Gel Containing Plumbago Zeylanica in Mild to Moderate Knee Osteoarthritis –A Single Armed Open Label Pilot Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain (VAS) Tenderness Shotha swelling Inflammation Stabdata Stiffness walking velocity
Study Overview
Brief Summary
Effect of Gel Containing Plumbago Zeylanica in Mild to Moderate Knee Osteoarthritis A Single Armed Open Label Pilot Clinical Trial Objectives To evaluate the efficacy of Plumbago zeylanica gel as topical application in mild to moderate Knee Osteoarthritis in pain To assess the safety of Plumbago zeylanica gel as topical application in mild to moderate Knee Osteoarthritis
Single centric Single Group clinical conditions having pain and inflammation with Pretest and Posttest design
30 patients with knee osteoarthritis meeting all inclusion/exclusion criteria will be included in the study
Trial medication Twice in a Day for a period of 7days Gel Containing Plumbago Zeylanica This will be applied at the site of pain
Follow-up will be on 0th & 8th day
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Mild and Moderate cases of knee osteoarthritis Willing to give consent for participating in the study Patients who are currently on analgesics NSAID will be given a washout period of 8 days prior to recruitment.
Exclusion Criteria
- •Patients having severe knee osteoarthritis Those who are suffering from dermatitis or had a history of dermatitis Pregnant and lactating women Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.
Outcomes
Primary Outcomes
Pain (VAS) Tenderness Shotha swelling Inflammation Stabdata Stiffness walking velocity
Time Frame: 0th Day. 7th Day
Secondary Outcomes
- Changes in following parameters between day 0day 8 day in CBC, LFT, RFT
Investigators
Dr Pradeep L Grampurohit
KAHERs Shri B M K Ayurveda Mahavidyalaya