Trials / Completed
CompletedNCT04661267
Randomized Trial of Regenexx Stem Cell Support Formula
A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Regenexx, LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Regenexx, LLC developed a nutritional supplement formula containing many components related to supporting healthy joints This oral, liquid supplement is intended to help improve joint and cartilage health while also increasing their joint function. The goal of this study is to measure changes in joint health and function for patients with knee OA taking this supplement for 2 months.
Detailed description
The study design is a double-blind, randomized, placebo-controlled multicenter study. Liquid Regenexx Stem Cell Support Formula compared to placebo control administered via oral application for 2 months to determine effect on knee function and pain in patients with knee OA. Treatment group: Forty patients randomized to the treatment group will receive daily doses of stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months. Control group: Forty patients randomized to the control group will receive a daily doses of placebo stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Stem Cell Support Formula | This liquid supplement contains the following ingredients: chondroitin sulfate, glucosamine sulfate, vitamin C (ascorbic acid), curcumin and Bioperine®, resveratrol, L-carnosine, bitter melon, and vitamin D. |
| DIETARY_SUPPLEMENT | Placebo | The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula. |
Timeline
- Start date
- 2021-02-03
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
- First posted
- 2020-12-10
- Last updated
- 2022-12-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04661267. Inclusion in this directory is not an endorsement.