An open labelled double arm non randomized phase II clinical trial, to evaluate the therapeutic efficacy of punnai vithai pattru (External therapy) Ammaiyaar Koonthal Chooranam (Internal medicine) in the management of Azhal keel vayu (Osteoarthritis)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Pattru External therapy) and Group II (Medicine and Pattru external therapy)
Study Overview
Brief Summary
Osteo arthritis is a form of arthritis that featuresthe breakdown and eventual loss of the cartilage of one or more joints. Eventually,cartilage begins to degenerate by flaking or forming tiny crevases. Osteoarthritisusually affects the weight bearing joint(i.e.knee joint, hip joint).The mostcommon symptoms of Osteo arthritis in pain in the joint after repetitive usealong with loss of range of motion and function.
A pattru (Poultice) is a form of herbal paste is obtained from plant extracts or grinding raw drugs with or without processing them. Normallt the medicine to be applied is made into a thick paste and applied over the affected region.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 35.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients having symptoms of pain in single or both knee joints, swelling, tenderness, stiffness, crepitation and restricted movements Patients who are willing to give blood samples for laboratory investigation Patients who are willing to take x ray before and after treatment Willing for admission in IPD for 48 days or wiling to attend OPD regularly Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent.
Exclusion Criteria
- •Cardiac disease Rheumatoid and other types of arthritis Pregnant women and lactating mothers Trauma, fracture and ligament injury Patients with any other serious illness Benign and malignant neoplasm Immuno compromised patients Dermatological issues.
Outcomes
Primary Outcomes
Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Pattru External therapy) and Group II (Medicine and Pattru external therapy)
Time Frame: 48 Days
Comparison of efficacy in patient Group I and Group II
Time Frame: 48 Days
Secondary Outcomes
- Assessment of quality of life by universal pain score scale(Assessment of safety parameters)