None listed
Conditions
Brief summary
Channa striatus is a fresh water fish belongs to the family Channidae, known as a valuable source of protein and natural remedy in traditional medicine in Southeast Asian region.Knee osteoarthritis is the leading cause of chronic disability at older age. Scientific studies have shown that Channa striatus (Haruan) extract has wound healing, anti-norciceptive and anti-inflammatory properties, thus postulated to have beneficial effects for osteoarthritis. This is a randomized, double-blind, placebo-controlled trial, four-arm parallel comparative study of 1000mg/day oral Channa striatus extract, 500mg/day oral Channa striatus extract, placebo and 1500mg/day glucosamine sulphate among patient who had primary knee osteoarthritis. Participants are randomly allocated into one of four groups. They will received the investigational product for six months duration. They will be assessed on pain, stiffness of the knee joints, physical function, quality of life, safety measures and also consumption of analgesics at baseline, month three and month six.
Interventions
a) All the different treatment arms and doses that are administered
Group A : Subject receive 1000mg/day oral Channa striatus extract
Group B: Subject receive 500mg/day oral Channa striatus extract
Group C : Subject receive 250mg/day of placebo
Group D : Subject receive Glucosamine Sulphate 1500mg/day
b) frequency and total duration of intervention.
The frequency of investigational product consumption: each patient will be taking two capsules twice a day irrespective of their groups (tot
a) All the different treatment arms and doses that are administered Group A : Subject receive 1000mg/day oral Channa striatus extract Group B: Subject receive 500mg/day oral Channa striatus extract Group C : Subject receive 250mg/day of placebo Group D : Subject receive Glucosamine Sulphate 1500mg/day b) frequency and total duration of intervention. The frequency of investigational product consumption: each patient will be taking two capsules twice a day irrespective of their groups (total of 4 capsules/day). Total duration of intervention : 6 months c) Mode of administration : oral d) Strategies used to monitor adherence/compliance: Subject will be asked to return all the unused medication. The number of capsules issued and minus the number of capsules returned will be used to calculate the capsules taken. From this information, compliance will be calculated. Compliance = (number of capsules taken / number of capsules required to be taken) x 100.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1- All patients with unilateral or bilateral knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR) (Altman et al. 1986) Knee pain and radiographic osteophytes plus at least one of three symptoms/signs listed below: -age more than 40 years OR -stiffness less than 30 minutes OR -crepitus. This criteria is widely accepted as the standard diagnosis criteria for knee OA with 91% sensitivity and 86% specificity. 2- Have a radiological grade between I and III, as measured with the Kellgren-Lawrence method of Classification. 3- Patients have symptoms for at least three months.
Exclusion criteria
1- Patient with secondary knee osteoarthritis, such as post traumatic OA, inflammatory arthritis, specifically rheumatoid arthritis, active gout 2- Disabling co-morbid condition such as renal disease, liver disease, neoplasm, and other rheumatic diseases. 3- Pregnancy or nursing. 4- Patient with severe knee pain and willing for surgical intervention. 5- Those who had joint lavage, arthroscopy, or treatment with hyaluronic acid during the previous 6 months. 6- Patient who had been treated with intra-articular corticosteroids during the past 3 months. 7- Patient who have allergic to oral C.striatus or Glucosamine
Outcome results
None listed