JointNCT07349264
Flexy3 Supplementation and Joint Health
A study testing Flexy3 Supplement (OriactivTM, Flexy3, Malaysia) in people with Joint and Joint Diseases, run by NXTVSION SDN. BHD. at 1 site in Malaysia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint, Joint Diseases
- What is being tested?
- Flexy3 Supplement (OriactivTM, Flexy3, Malaysia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Joint, Joint Diseases
- Being tested
- Flexy3 Supplement (OriactivTM, Flexy3, Malaysia), Placebo
- Keywords
- Arthritis, Boswellia serrata, Curcumin, Methylsulfonylmethane, Quality of Life
- Medical subject headings
- Joint Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexy3 Supplement (OriactivTM, Flexy3, Malaysia)Dietary supplement
Each capsule (500mg) consisted of B. serrata gum extract (100mg), Curcuma Longa (Turmeric) rhizome extract (150mg) and MSM (250mg).
PlaceboOther
The placebo consisted of capsules containing only excipients and food coloring, formulated to match the appearance of the active supplement.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm (Flexy3) | Experimental | 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. Receives: Dietary Supplement: Flexy3 Supplement (OriactivTM, Flexy3, Malaysia) |
| Placebo Arm | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation Levels
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)
Measured: Week 0, 4, 8 and 12
Severity and Symptoms of Arthritis
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).
Measured: Week 0, 4, 8 and 12
Secondary outcomes (1)
Standardized health-related quality of life (HRQoL)
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).
Measured: Week 0, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NXTVSION SDN. BHD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349264
- Sponsor's protocol ID
- Flexy3-Protocol-0001
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Wolfe F. Determinants of WOMAC function, pain and stiffness scores: evidence for the role of low back pain, symptom counts, fatigue and depression in osteoarthritis, rheumatoid arthritis and fibromyalgia. Rheumatology (Oxford). 1999 Apr;38(4):355-61. doi: 10.1093/rheumatology/38.4.355.
PubMed 10378714Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boswellia Serrata, Curcumin, and Methylsulfonylmethane Combination Supplementation Improves Joint Health
- ClinicalTrials.gov ID
- NCT07349264
- Acronym / sponsor ID
- Flexy3-Protocol-0001
- Conditions
- Joint, Joint Diseases
- Keywords
- Arthritis, Boswellia serrata, Curcumin, Methylsulfonylmethane, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NXTVSION SDN. BHD.Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm (Flexy3) | Experimental | Dietary Supplement: Flexy3 Supplement (OriactivTM, Flexy3, Malaysia)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. |
| Placebo Arm | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexy3 Supplement (OriactivTM, Flexy3, Malaysia)Each capsule (500mg) consisted of B. serrata gum extract (100mg), Curcuma Longa (Turmeric) rhizome extract (150mg) and MSM (250mg). | Dietary supplement | Interventional Arm (Flexy3) |
| PlaceboThe placebo consisted of capsules containing only excipients and food coloring, formulated to match the appearance of the active supplement. | Other | Placebo Arm |
Primary outcome
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)
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).
1 secondary outcome
Standardized health-related quality of life (HRQoL)
Time frame: Week 0, 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Results publication: PubMed 10378714Wolfe F. Determinants of WOMAC function, pain and stiffness scores: evidence for the role of low back pain, symptom counts, fatigue and depression in osteoarthritis, rheumatoid arthritis and fibromyalgia. Rheumatology (Oxford). 1999 Apr;38(4):355-61. doi: 10.1093/rheumatology/38.4.355.
- Results publication: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexy3 Supplement (OriactivTM, Flexy3, Malaysia) in people with Joint and Joint Diseases, run by NXTVSION SDN. BHD. at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation Levels (time frame: Week 0, 4, 8 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07349264, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.