The Potential Effect of Bitter Melon Supplementation in Pain Reduction Among Osteoarthritis Patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008649
• Date of registration: 25-05-2017
• Prospective Registration: No
• Primary sponsor: School of Medical Sciences
• Public title: The Potential Effect of Bitter Melon Supplementation in Pain Reduction Among Osteoarthritis Patients
• Scientific title: The Potential Effect of Momordica Charantia (Bitter Melon) in Pain Reduction among Primary Knee Osteoarthritis Patients in Hospital Universiti Sains Malaysia
• Date of first enrolment: 07-09-2015
• Target sample size: 76
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13610
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded
• Phase: Phase 1

Countries of recruitment

Malaysia

Contacts

• Name: Dr Md Rizman Bin Md Lazin
• Affiliation: Universiti Sains Malaysia

• Name: Dr Md Rizman Bin Md Lazin
• Affiliation: Universiti Sains Malaysia

Key inclusion & exclusion criteria

Inclusion criteria: 1- Patients are within stable condition and willing to be involve in this study.



2- All patients with unilateral or bilateral knee osteoarthritis according to clinical and radiological criteria of the American college of Rheumatology (ACR).



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. (Altman et al, 1986).



3- Have a radiological grade between I and III, as measured with the Kellgren-Lawrence method.



Grade I: doubtful narrowing of joint space and possible osteophytic lipping.

Grade II: defined osteophytes and possible narrowing of joint space.

Grade III: Moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends (Kellgren & Lawrence, 1957).


Exclusion criteria: 1- Patients are within unstable condition and unwilling to be involve in this study.



2- Patient with secondary knee osteoarthritis, such as post traumatic OA, inflammatory arthritis, specifically rheumatoid arthritis, active gout (Giordano et al 2009).



3- Disabling co-morbid condition such as severe hematologic disorders, renal disease, liver disease, neoplasms, diabetes mellitus and other rheumatic diseases. (Giordano et al 2009)



4- Pregnancy or nursing. (Giordano et al 2009)



5- Patient with grade IV OA: Large osteophytes marked narrowing of joint space, severe sclerosis and definite deformity of bones ends. (Kellgren & Lawrence, 1957)



6- Patient with severe knee pain and willing for surgical intervention.



7- Those who had joint lavage, arthroscopy, or treatment with hyaluronic acid, or glucosamine during the previous 6 months. (Giordano et al 2009)



8- Patient who had been treated with intra-articular corticosteroids during the past 3 months. ( Giordano et al, 2009)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Primary unilateral or bilateral knee osteoarthritis according to clinical and radiological criteria of the American college of Rheumatology (ACR).

Intervention(s)

Intervention1: Momordica charantia (bitter melon): Momordica charantia (bitter melon) crude extract capsules (500mg). 3 capsules orally thrice daily post meal for 12 weeks.
Control Intervention1: Placebo: Corn starch capsules (500mg).
3 capsules orally thrice daily post meal for 12 weeks.

Primary Outcome(s)

The Knee Injury and Osteoarthritis Outcome Score (KOOS)Timepoint: At baseline, every 4 weeks for 12 weeks

Secondary Outcome(s)

Inflammatory and metabolic profileTimepoint: At baseline and after supplementation completed (week 12)

Secondary ID(s)

NIL

Source(s) of Monetary Support

Short Term Research Grant School of Medical Sciences Universiti Sains Malaysia

Ethics review

Status: Approved
Approval date: 28/01/2015
Contact:

Human Research Ethics Committee USM (HREC)