The effect of oral Channa striatus extract versus Glucosamine sulphate on Knee Osteoarthritis patients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000901505
• Date of registration: 27/08/2015
• Prospective Registration: No
• Primary sponsor: Universiti Sains Malaysia
• Public title: The effect of oral Channa striatus extract versus Glucosamine sulphate on Knee Osteoarthritis patients
• Scientific title: A double blind randomized controlled study to evaluate the efficacy of different doses of oral Channa striatus extract versus Glucosamine Sulphate among knee osteoarthritis patients
• Date of first enrolment: 01/09/2014
• Target sample size: 156
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000901505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Malaysia

Contacts

• Name: A/Prof Azidah Abdul Kadir

• Name: A/Prof Azidah Abdul Kadir

Key inclusion & exclusion criteria

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


Age minimum: 40 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Osteoarthritis

knee osteoarthritis;
knee osteoarthritis

Intervention(s)

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.

Primary Outcome(s)

Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain index at 3 months and 6 months post intervention[Baseline and 3 and 6 months post commencement of intervention]

Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) physical function index at 3 months and 6 months post intervention[Baseline and 3 and 6 months post commencement of intervention]

Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) stiffness index at 3 months and 6 months post intervention[Baseline and 3 and 6 months post commencement of intervention]

Secondary Outcome(s)

Consumption of NSAIDs or Paracetamol by using analgesic score designed specifically for this study.
[Baseline and 3 and 6 months post commencement of intervention]

Proportion of participants achieving a 50% improvement in WOMAC pain score.[6 months post intervention]

The level of inflammatory marker (blood sample) - cartilage oligomeric matrix protein (COMP) ) and PGE2 level and COX level
[Baseline and 6 months post commencement of intervention]

Quality of life questionnaire using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) Questionnaire
[Baseline and 3 and 6 months post commencement of intervention]

Proportion of participants achieving a 20% improvement in WOMAC pain score.[6 months post intervention]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Universiti Sains Malaysia

Ethics review

Status: Approved
Approval date:
Contact:

Research Ethical Comittee (Human) USM