Flexy3 Supplementation and Joint Health

January 9, 2026 updated by: NXTVSION SDN. BHD.

Boswellia Serrata, Curcumin, and Methylsulfonylmethane Combination Supplementation Improves Joint Health

The prevalence of osteoarthritis (OA) of the knee, hip, and hand has been estimated at 20% to 30% in the adult population (Neogi and Zhang, 2012). Knee OA is the most common form with prevalence increases throughout the lifespan (Wallace et al., 2017, Nguyen et al., 2011). Globally, knee and hip OA were estimated to be the 11th greatest contributors to years of life lived with disability in 2010 (Cross et al., 2014). On the other hand, rheumatoid arthritis (RA) has been reported to affect 0.1-2.0% of the population worldwide (Almutairi et al., 2021). As with any disease, identifying novel treatment options for managing arthritis and promoting joint health requires an understanding of the underlying etiology that leads to the development of the observed symptoms (Guo et al., 2018, Sandell, 2012). The pathophysiology of cartilage degradation in arthritis is multifactorial, primarily driven by pro-inflammatory cytokines and oxidative stress, and further exacerbated by metabolic comorbidities. (e.g., obesity, diabetes) (Rahmati et al., 2017, Markovics et al., 2021).

In vitro evidence suggests that some natural products may possess anti-inflammatory and anti-oxidative properties and may inhibit the release of key osteoarthritis-related cytokines. There is, therefore, ongoing interest in identifying natural products that safely promote joint health and treat osteoarthritis. Numerous plant extracts, including curcumin, Boswellia extract, and pycnogenol, have shown effect sizes (ES) for reducing pain and functional disability larger than those observed with analgesics and products such as glucosamine and chondroitin (Henrotin and Mobasheri, 2018). A recent literature review and meta-analysis conducted by Liu et al. (2018) reported that a number of natural products produced clinically important effect sizes (ES) of -1.2 to - 1.6 in randomized, controlled trials (RCTs), that exceed what has been observed with traditional OA treatments such as glucosamine and chondroitin, which showed no or small effects (ES = - 0.28 to - 0.34) (Liu et al., 2018a, Liu et al., 2018b).

Boswellia serrata is a tree that is widely distributed in India, and its oily gum resin has traditionally been used for centuries in humans as a remedy to treat inflammatory diseases (Siddiqui, 2011). The resinous part of Boswellia serrata possesses monoterpenes, diterpenes, triterpenes, tetracyclic triterpenic acids and four major pentacyclic triterpenic acids, i.e., β-boswellic acid, acetyl-β-boswellic acid (AβBA), 11-keto-β-boswellic acid and acetyl-11-keto-β-boswellic acid (AKBA) (Al-Yasiry and Kiczorowska, 2016). Boswellic acids with the characteristic pentacyclic triterpene ring can exhibit actions related to the inflammatory cascade, with AKBA being more active, selectively inhibiting a branch of the arachidonic acid cascade (5 LOX) related to the production of leukotrienes without affecting other activities of LOX and COX. The inhibition of 5 LOX and leukotriene synthesis reduces the levels of pro-inflammatory cytokines, leading to decreased cartilage destruction and inflammatory cell chemotaxis and producing a balance in favour of cartilage regeneration (Ammon, 2006, Ammon, 2010).

Boswellia serrata has garnered significant attention for its potential anti-inflammatory and joint-supporting properties. Despite its growing popularity as a supplement, there is a need for more robust, evidence-based research to establish its efficacy in improving joint health. By studying the effects of Boswellia serrata supplementation, this research aims to address gaps in the existing literature, and contribute to the development of effective, natural interventions for individuals experiencing joint discomfort and impaired mobility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • UCSI University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subject with the complains of either pain or stiffness on joint, difficulty in walking and dressing due to arthritis or joint problem that interfered work/daily routine or social activities in the past 3 months
  • At least 2/10 on pain scores using visual analogue scale (VAS)
  • Age 18 or above
  • Willing to comply with interventional plan and comes to do follow up
  • Willing to gives consent

Exclusion Criteria:

  • Use of any NSAIDS in the last 48 hours
  • Use of any Intramuscular/intra-articular/systemic corticosteroid in the last 30 days
  • Use of any supplements targeting joint health in the last 30 days
  • Significant trauma to knees, including arthroscopy or significant injury to ligaments or menisci of the knee in the last 3 months
  • Subject who is currently on medication
  • Subject with chronic diseases, including but not limited to hypertension, diabetes, cancer, cardiovascular diseases, chronic respiratory diseases, neurological conditions.
  • Pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm (Flexy3)
The intervention supplement is made in vega capsule form (OriactivTM, Flexy3, Malaysia). Each capsule (500mg) consisted of B. serrata gum extract (100mg), Curcuma Longa (Turmeric) rhizome extract (150mg) and MSM (250mg). Participants were instructed to take two capsules twice daily.
Dietary supplement: Flexy3 Supplement (OriactivTM, Flexy3, Malaysia)
Each capsule (500mg) consisted of B. serrata gum extract (100mg), Curcuma Longa (Turmeric) rhizome extract (150mg) and MSM (250mg).
Placebo Comparator: Placebo Arm
The placebo consisted of capsules containing only excipients and food coloring, formulated to match the appearance of the active supplement. Participants were instructed to take two capsules twice daily.
Other: Placebo
The placebo consisted of capsules containing only excipients and food coloring, formulated to match the appearance of the active supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation Levels
Time Frame: Week 0, 4, 8 and 12
Inflammation levels was determined through the biomarkers Matrix Metalloproteinase 8 (MMP-8) , interleukin-1 beta (IL-1b) and tumour necrosis factor-alpha (TNF-a). The levels of interleukin-1 beta (IL-1b) and tumour necrosis factor-alpha (TNF-a) were assayed using ELISA MAX™ Deluxe Set Human IL-1β and ELISA MAX™ Deluxe Set Human TNF-α (BioLegend, Inc) respectively. The level of matrix metalloproteinase 8 (MMP-8) was measured using human MMP-8(Matrix Metalloproteinase 8) ELISA Kit (Elabscience Biotechnology Co., Ltd., Houston, TX, USA)
Week 0, 4, 8 and 12
Severity and Symptoms of Arthritis
Time Frame: Week 0, 4, 8 and 12
Severity and symptoms of arthritis was measured using Western Ontario and McMaster Universities Osteoarthritis Index. The WOMAC Index is a validated, self-administered questionnaire designed to assess three dimensions of joint health: pain (five items), stiffness (two items), and physical function (16 items).
Week 0, 4, 8 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized health-related quality of life (HRQoL)
Time Frame: Week 0, 4, 8 and 12
Quality of life was determined using EQ-5D-5L. The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each rated on five levels of severity (no problems, slight problems, moderate problems, severe problems, extreme problems).
Week 0, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NXTVSION SDN. BHD.

Collaborators

UCSI University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flexy3-Protocol-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional docu-ments including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following pub-lication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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