רדאר קליני AI | ||
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הניסוי הקליני NCT07493239 עבור Joint Health הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
A Decentralized Clinical Study Evaluating the Effectiveness of Two Different Doses of MyCondro™ on Physical Mobility and Joint Health 240 מבוזר
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07493239 הוא מחקר מסוג התערבותי עבור Joint Health, שנמצא כעת במצב מגייס. המחקר התחיל ב-1 במרץ 2026 ומתוכנן לכלול 240 משתתפים. המחקר מנוהל על ידי Lesaffre International וצפוי להסתיים ב-2 בנובמבר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-25 במרץ 2026.
סיכום קצר
This study evaluates the effect of two different doses of a consumer-grade product, MyCondro™, on individuals experiencing mobility issues related to knee osteoarthritis. The primary goal is to measure improvements in overall joint health and mobility by tracking changes in participants' total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores from the beginning to the end of the trial. Add...הצג עוד
תיאור מפורט
This decentralized, consumer-driven clinical study is designed to evaluate the impact of two different doses of MyCondro™, a consumer-grade product, on physical mobility and joint health in adults aged 45 and older with self-reported knee osteoarthritis. The primary objective is to assess the change from baseline in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score within each dos...הצג עוד
כותרת רשמית
A Randomized, Double-blind Study Evaluating the Effectiveness of Two Different Doses of MyCondroTM on Physical Mobility and Joint Health Using Participant-Reported Outcomes in Individuals With Self-Reported Mobility Issues Associated With Knee Osteoarthritis
מצבים רפואיים
Joint Healthמזהי מחקר נוספים
- PS24
מספר NCT
תחילת המחקר (בפועל)
2026-03
עדכון אחרון שפורסם
2026-03-25
סיום המחקר (מוערך)
2026-11-02
משתתפים (מתוכנן)
240
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מילות מפתח
MyCondro, Gnosis, PS24
Joint function
Joint mobility
non-animal chondroitin sulfate
Joint function
Joint mobility
non-animal chondroitin sulfate
מטרה ראשית
טיפול תומך
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
משולש
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסי300 mg Participants in this arm will receive a 300 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period | MyCondro 300mg This is a non-animal Chondroitin sulfate formulation. |
ניסי600 mg Participants in this arm will receive a 600 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period | MyCondro 600mg This is a non-animal Chondroitin sulfate formulation. |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
MyCondro's effectiveness | To evaluate the effectiveness of two different doses of MyCondro on mobility, activity, and joint health by measuring the change in total WOMAC scores from baseline to the end of the study within each dose group | 12 weeks |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Knee Symptoms and Physical Function | This outcome evaluates the product's effect on overall joint health and mobility. Efficacy is measured by tracking the change from baseline in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-assessing pain, stiffness, and physical function-and the TLKS (Tegner Lysholm Knee Scoring Scale). Data will be collected at 1 month, 2 months, and the end of the study to compare improvements within and between the two dose groups. | 14 weeks |
Knee pain at rest and in motion | This objective specifically assesses the product's impact on acute and chronic pain levels during different physical states. Utilizing a daily numeric rating scale (NRS), the investigators will track the change from baseline in average weekly knee pain scores-both at rest and in motion-comparing the outcomes between the two dosage groups. | 14 Weeks |
Subjective Impression of Improvement | This measure captures the participant's personal perception of their symptom relief and overall disease activity. It calculates the change from baseline in the average PGADA (Patient Global Assessment of Disease Activity) score at 1 month, 2 months, and the end of the study to determine if either dose group experiences a more noticeable subjective improvement. | 14 weeks |
Overall Quality of Life | This objective examines the broader, holistic impact of the study product on a participant's daily living and well-being. By comparing baseline Short Form 36 (SF-36) health survey scores to those collected at the study's conclusion, the study investigators can analyze changes in general quality of life between the two doses. | 14 weeks |
Systemic Inflammatory Blood Markers | This objective investigates the physiological effects of the study product on underlying inflammation. The study investigators will measure the change from baseline in high-sensitivity C-reactive protein (hs-CRP) levels at the end of the study to evaluate and compare the biochemical impact of the two different doses. | 14 weeks |
Reliance on Rescue Medications | This outcome tracks the ongoing need for supplementary pain relief during the trial. It evaluates the frequency of standard rescue medication use (paracetamol/acetaminophen and oral NSAIDs) during the product use period. This metric tracks the ongoing need for supplementary pain relief, and differences in usage between the dose groups via a daily diary. | 14 weeks |
Safety and Tolerability | This critical measure ensures the study product is safe for consumer use at both the 300mg and 600mg dosages. The study team will track and assess the number, frequency, and severity of all adverse events (AEs), serious adverse events (SAEs), and any trial withdrawals caused by AEs throughout the duration of the product use period. | 14 weeks |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
45 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן
- Individuals age 45 years and older.
- BMI range between 18-35 kg/m².
- Self-reported mobility issues, including mobility impairment and joint discomfort associated with a known diagnosis of Knee Osteoarthritis. This impairment and discomfort must have persisted for at least 6 months prior to randomization and have been actively experienced within the last 3 months.
- Willingness to avoid high Chondroitin Sulfate-containing foods (i.e., animal cartilages, bones, or derivatives such as gelatin) for the duration of the study period.
- Willingness to refrain from supplements containing Chondroitin Sulfate for the duration of the study period.
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download the Chloe by People Science app.
- Able to receive shipments of the product at an address within the United States.
- Able to complete study assessments over the course of up to 16 weeks.
Any potential participants will be excluded if they meet any of the following criteria:
Technology Limitation: Do not have a personal smartphone, lack internet access, or are unwilling to download the Chloe app.
Concomitant Therapies
- Use of a Chondroitin Sulfate supplement in the 3 months prior to randomization.
- Current use of other joint health supplements (e.g., glucosamine, hyaluronic acid, collagen peptides) for at least 4 weeks prior to randomization.
- Use of any intra-articular or intravenous steroid injections in the last 3 months.
- Receiving any investigational therapies or treatments within 30 days prior to randomization.
Other Illnesses or Conditions
- Self-reported inflammatory arthropathies, such as Rheumatoid Arthritis, Gout, and Infectious Arthritis.
- Significant systemic lung, liver, heart, or kidney disease (excluding hypertension).
- Prior history of knee surgery within 3 months preceding the study period, or planned knee surgery (including arthroscopy) during the study period.
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
- Currently pregnant, planning to become pregnant in the next 20 weeks, or breastfeeding.
- Presence of a knee prosthesis.
- Any significant illness, disease, or condition which, in the opinion of the Principal Investigator, may impact the ability to participate in the study or impact the study outcomes.
Allergies and Intolerances
- Known hypersensitivity or previous allergic reaction to: Chondroitin sulfate, Maltodextrin, Mannitol, Magnesium Stearate, Silicon dioxide, Microcrystalline cellulose, or Talc.
- Known sensitivity or intolerance to wheat or gluten.
General Compliance
1- Unlikely for any reason to be able to comply with the trial, or considered unsuited for participation in the study by the Principal Investigator.
Lesaffre InternationalPeople Scienceאיש קשר מרכזי למחקר
איש קשר: Victoria Oyedokun, PhD, +4915163496903, [email protected]
איש קשר: Yann Fardini, PhD, [email protected]
1 מיקומי המחקר ב-1 מדינות
California
People Science, Los Angeles, California, 90045, United States
Miguel Rosales, MS, איש קשר, 8186451478, [email protected]
Crisel Erfe, MD, איש קשר, [email protected]
Noah Craft, MD, PhD, חוקר ראשי
מגייס