A randomized parallel group open label standard controlled clinical study to evaluate the therapeutic efficacy and safety of Dalk layyin kathir with Ravghan i Qust in Knee Osteoarthritis (Waja al rukba)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- 1.KOOS Index
Overview
Brief Summary
Osteoarthritis is the most common type of arthritis, with the knee being the most frequently affected large joint. It is marked by focal cartilage loss, subchondral bone sclerosis, and the formation of osteophytes. Knee Osteoarthritis (KOA) is a major cause of painful walking and is more common in females. It affects around 250 million people worldwide and has a prevalence of 22% to 39% in India. KOA can be primary or secondary, with early signs including joint space narrowing, best seen in weight-bearing X-rays. Osteophytes are the hallmark, and other changes include subchondral cysts, deformities, loose bodies, and calcifications. CT, ultrasound, and MRI can help in diagnosis. The main goal of treatment is pain relief and slowing disease progression, as the condition is incurable. Analgesics and anti-inflammatory drugs are first-line treatments but have potential side effects such as gastrointestinal, cardiovascular, and renal complications. In the Unani system of medicine, KOA is included under the general term Waja al Mafasil, which covers all types of arthritis. Waja al Rukba refers to knee pain. Unani treatment is based on the principles described for Waja al Mafasil and includes three approaches: Ilaj bil Tadbir wa Taghzia, Ilaj bil Dawa, and Ilaj bil Yad. Among non-pharmacological methods, Dalk (massage) is an important regimen for musculoskeletal and other disorders. Dalk Layyin with Ravghan i Qust is mentioned for treating Waja al Mafasil, but its efficacy and safety have not been scientifically validated. This study is planned to evaluate its role in managing KOA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Unilateral or Bilateral KOA 2.Diagnosed patients of KOA based on clinical and or radiographic criteria such as those established by the American College of Rheumatology (ACR) 3.Patient classified as grade 2 or 3 for KOA according to the Kellgren Lawrence Grading System 4.Radiographic Evidence presence of characteristic changes on knee X-rays such as joint space narrowing, osteophytes, and subchondral bone changes 5.Symptoms persisting for a specified period often at least six months 6.At screening, patients on any analgesic anti-inflammatory medication shall be screened on the Visual Analogue Scale (VAS) of pain after walking on a 50 ft.
- •flat surface of more than30 mm but less than 90 mm using a 100 mm scale.
- •If patients taking no analgesic anti-inflammatory medication in the previous 3 days from screening then they should have a VAS pain score after walking on a 50 ft.
- •flat surface of more than 40 mm but less than 90 mm If bilateral knee pain is present the more painful knee will be selected 7.Patient who can perform the 50 ft walk test without the support of crutches or other assistive devices 8.Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition, including their knee pain 9.Patient fulfilling the inclusion criteria and agree to follow the protocol 10.Willingness and ability to comply with study requirements including attending study visits and completing assessments.
Exclusion Criteria
- •Pregnant & lactating women Patients participating in an experimental device, study or any clinical trial within the previous 30 days before screening Other types of arthritis (Rheumatoid Arthritis, Gout) etc Osteoporosis, Venous disorders.
- •Any knee surgery in the previous three months.
- •Use of oral corticosteroids within the past 3 weeks Intra articular depo corticosteroids within the previous 3 months or intra articular hyaluronate within the previous 3 months Arthroscopy of the knee within the previous year.
- •Patient with Kellgren Lawrence Grade 0, 1 and Grade 4 KOA Concomitant skin disease at the application site.
- •Significant injury to the knee within the previous 6 months or a rash or open wound over the knee.
- •Patients with any intercurrent disease or condition that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the follow up (Neurological problems, Severe Congenital Defects, Peptic Ulcer, Severe Liver Diseases, Severe Coronary Diseases, Renal Diseases, Active Psychiatric Disorders, or other clinically significant conditions).
- •Patients who will be unwilling to participate in the study.
Outcomes
Primary Outcomes
1.KOOS Index
Time Frame: On Day 7,14,28 and 35
2.VAS
Time Frame: On Day 7,14,28 and 35
3.Active Range of Motion (AROM)
Time Frame: On Day 7,14,28 and 35
4.Eight-meter walk test
Time Frame: On Day 7,14,28 and 35
Secondary Outcomes
- Quality of life(On Day 7,14,28 and 35)
Investigators
Mohd Sameer
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital