Efficacy of Dalk Layyin Kathir With Roghan Bedanjeer versus Hijama- Bila-Shart in Waja-ur-Rukba (Knee Osteoarthritis):A Randomised comparative clinical trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- VAS for knee pain
Study Overview
Brief Summary
Knee osteoarthritis is one of the commonest rheumatological health problem across the globe. It is a degenerative joint disease of the knee which typically results from wear and tear and progressive loss of articular cartilage of the knees.(1).With a prevalence of 365 million, the knee is the most frequently affected joint, followed by the hip and the hand(2). 344 million people living with osteoarthritis experience severity levels (moderate or severe) that could benefit from rehabilitation (3). The prevalence of osteoarthritis is 22% to 39% in India. Women are more frequently affected than men. However, the prevalence is on rise due to ageing. On an average 45% of women above 65 years’ experience the symptoms. The radiological evidence is seen in 70% of the people over 65 years. Osteoarthritis is estimated to be 10th leading cause of non-fatal burden (4). Osteoarthritis is the eighth common predictor of health problem in men and fourth common predictor in women across the world (5). It is primarily treated with non-steroidal anti-inflammatory drugs(NSAIDS) and corticosteroids in modern medicine which have many adverse effects like acute renal dysfunction, fluid and electrolyte disorders, renal papillary necrosis, and nephrotic syndrome/ interstitial nephritis, etc.(6) Thus, it warrants that the safer and efficacious treatment modality should be explored for the amelioration and betterment of quality of life of the patients and Unani system of medicine has a great potential for the management of knee osteoarthritis with pharmacological and various regimental procedures.
In Unani medicine, knee osteoarthritis is clinically similar with Waja-ur-Rukba, a subtype of Waja-ul-Mafasil. It has been defined as the pain and swelling of knee joints (7). It is chiefly caused by dominance of morbid phlegm in knees resulting in touting of cartilages and swelling of knee joints (8).
Because of high prevalence and disease complications, now a days everyone is attracted globally towards a treatment modality with minimal or no use of drugs, and IBT, a branch of Unani system of medicine fulfils this necessity as it uses different regimens for the treatment of disease. Hijama and Dalk are regimens used in Ilaj-bit-Tadbeer to manage several diseases including Waja-ur-Rukba. These have been described in the classical literature to be effective and that too without any chance of producing side effects or minimal side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 40-70 years from both gender.
- •ACR (Clinical/ radiographic classification) criteria including presence of knee pain with at least one of the following three items along with osteophytes in knee X-ray.
- •Age more than 50 years.
- •Morning stiffness less than 30 minutes Crepitus on active motion Patients having Knee OA of 1 and 2nd grade according to Kellgren Lawrence classification.
- •Patients who will give consent and able to do follow up.
Exclusion Criteria
- •Participants below 40 and above 70 years of age.
- •Pregnant and lactating women.
- •Patients with severe systemic illness.
- •Patients who have received CAM therapy including analgesics, systemic/topical Steroids within last 1 month duration.
- •Other form of arthritis like rheumatoid arthritis, gout, secondary knee osteoarthritis.
- •Patient with history of trauma and accident involving knee joint.
Outcomes
Primary Outcomes
VAS for knee pain
Time Frame: 7th, 14th, 21st, and 28th day
Secondary Outcomes
- VOMAC(7th,14th,21st,and 28th days)
Investigators
Mohd Saeb
State Unani Medical college