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Trial registered on ANZCTR


Registration number
ACTRN12615000901505
Ethics application status
Approved
Date submitted
6/04/2015
Date registered
27/08/2015
Date last updated
19/07/2017
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 286480 0
Nil known
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 294671 0
Condition category
Condition code
Musculoskeletal 294976 294976 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291567 0
Treatment: Drugs
Comparator / control treatment
cornstarch
Control group
Placebo

Outcomes
Primary outcome [1] 294726 0
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain index at 3 months and 6 months post intervention
Timepoint [1] 294726 0
Baseline and 3 and 6 months post commencement of intervention
Primary outcome [2] 295745 0
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) stiffness index at 3 months and 6 months post intervention
Timepoint [2] 295745 0
Baseline and 3 and 6 months post commencement of intervention
Primary outcome [3] 295746 0
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) physical function index at 3 months and 6 months post intervention
Timepoint [3] 295746 0
Baseline and 3 and 6 months post commencement of intervention
Secondary outcome [1] 313933 0
Consumption of NSAIDs or Paracetamol by using analgesic score designed specifically for this study.
Timepoint [1] 313933 0
Baseline and 3 and 6 months post commencement of intervention
Secondary outcome [2] 316395 0
The level of inflammatory marker (blood sample) - cartilage oligomeric matrix protein (COMP) ) and PGE2 level and COX level
Timepoint [2] 316395 0
Baseline and 6 months post commencement of intervention
Secondary outcome [3] 316396 0
Quality of life questionnaire using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) Questionnaire
Timepoint [3] 316396 0
Baseline and 3 and 6 months post commencement of intervention
Secondary outcome [4] 336857 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [4] 336857 0
6 months post intervention
Secondary outcome [5] 336858 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [5] 336858 0
6 months post intervention
Secondary outcome [6] 337040 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [6] 337040 0
6 months post intervention
Secondary outcome [7] 337041 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [7] 337041 0
6 months post intervention
Secondary outcome [8] 337042 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [8] 337042 0
6 months post intervention
Secondary outcome [9] 337043 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [9] 337043 0
6 months post intervention
Secondary outcome [10] 337044 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [10] 337044 0
6 months post intervention
Secondary outcome [11] 337045 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [11] 337045 0
6 months post intervention
Secondary outcome [12] 337046 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [12] 337046 0
6 months post intervention
Secondary outcome [13] 337047 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [13] 337047 0
6 months post intervention
Secondary outcome [14] 337048 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [14] 337048 0
6 months post intervention
Secondary outcome [15] 337089 0
Proportion of participants achieving a 20% improvement in WOMAC pain score.
Timepoint [15] 337089 0
6 months post intervention
Secondary outcome [16] 337090 0
Proportion of participants achieving a 50% improvement in WOMAC pain score.
Timepoint [16] 337090 0
6 months post intervention

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study statistician randomizes assignments as generated using computer that provided allocation of subject numbers in a ratio of 1:1:1:1 to either 1000mg/day oral Channa striatus extract, 500mg/day oral Channa striatus extract, placebo group or 1500mg/day Glucosamine Sulphate using Sealed EnvelopeTM method. These assignments are then puts into sealed, opaque envelopes, numbered sequentially and sent to a study staff member that involved within the field work. The staff will open the consecutive envelope to randomize eligible patient accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers using Sealed Envelope method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated using Power and Sample Size calculation software (Dupont and Plummer, 1997) Sample size for comparing two means between treatment group (1000mg of CS extract) and placebo group were done. The parameters were as follows:
Level of significance = 0.05 , Power 0.9 , Standard deviation of outcome variables = 2.3 (N. Giordano et. al 2009), detectable diff in pop means (clinically sig difference in pain score between C.striatus extract group and placebo (cornstarch) group based on expert opinion) = 1.9 and the ratio between placebo group and Channa striatus extract group = 1
The minimum required sample size was 32 and after considering the drop out rate of 20%, the sample size calculated for each group was 39.
Analyses will be done by using SPSS for windows version 22.0. Baseline data will be analyze using ANOVA and simple logistic regression. To determine the differences in the outcome parameters, repeated measures analysis of variance (RM ANCOVA) will be used while controlling for weight and age for pain, stiffness, functional score and quality of life score. Changes were reported as estimated marginal means with its adjusted 95% Confidence Interval (CI). All reported p-values are 2-tailed with a value of less than 0.05 which is considered significant. For analgesic score and laboratory parameters ANOVA test will be used to detect the difference of the score between both groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6788 0
Malaysia
State/province [1] 6788 0

Funding & Sponsors
Funding source category [1] 291044 0
University
Name [1] 291044 0
Universiti Sains Malaysia
Address [1] 291044 0
Universiti Sains Malaysia, Kubang Kerian, 16150, Kelantan, Malaysia
Country [1] 291044 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Universiti Sains Malaysia, Kubang Kerian, 16150, Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 289727 0
None
Name [1] 289727 0
Address [1] 289727 0
Country [1] 289727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292628 0
Research Ethical Comittee (Human) USM
Ethics committee address [1] 292628 0
Research Ethical Comittee (Human) USM,
Universiti Sains Malaysia, Kampus Kesihatan, Kubang Kerian,16150, Kelantan, Malaysia
Ethics committee country [1] 292628 0
Malaysia
Date submitted for ethics approval [1] 292628 0
Approval date [1] 292628 0
27/11/2013
Ethics approval number [1] 292628 0
USM/JEPeM/272.2(10)

Summary
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.
Trial website
nil
Trial related presentations / publications
presentations at conference:
1. Malaysian Society of Pharmacology and Physiology Conference 2016 , Shangrila Hotel Putrajaya, Malaysia, 15-16 August 2016
2. 20th World Congress of Clinical Nutrition (WCCN). Rama Garden Hotel, Bangkok Thailand, 14-16 Dec. 2016
Public notes
nil

Contacts
Principal investigator
Name 56318 0
A/Prof Azidah Abdul Kadir
Address 56318 0
Department of Family Medicine
School of Medical Sciences
Health Campus, Universiti Sains Malaysia
16150, Kubang Kerian, Kelantan
Malaysia
Country 56318 0
Malaysia
Phone 56318 0
+60129286006
Fax 56318 0
+609-7676611
Email 56318 0
azidahkb@usm.my
Contact person for public queries
Name 56319 0
A/Prof Azidah Abdul Kadir
Address 56319 0
Department of Family Medicine
School of Medical Sciences
Health Campus, Universiti Sains Malaysia
16150, Kubang Kerian, Kelantan
Malaysia
Country 56319 0
Malaysia
Phone 56319 0
+60129286006
Fax 56319 0
+609-7676611
Email 56319 0
azidahkb@usm.my
Contact person for scientific queries
Name 56320 0
A/Prof Azidah Abdul Kadir
Address 56320 0
Department of Family Medicine
School of Medical Sciences
Health Campus, Universiti Sains Malaysia
16150, Kubang Kerian, Kelantan
Malaysia
Country 56320 0
Malaysia
Phone 56320 0
+60129286006
Fax 56320 0
+609-7676611
Email 56320 0
azidahkb@usm.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary