Effect of JointIQ on Joint Discomfort in Healthy Subjects

January 27, 2026 updated by: Chung Shan Medical University

Effect of JointIQ on Joint Discomfort in Healthy Subjects: A Randomized, Double-blind Trial

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of astragaloside supplementation on joint discomfort in healthy adults. The primary goal is to determine if daily intake of astragaloside can improve knee joint function and reduce discomfort over a 12-week period. Participants will be randomly assigned to receive either an astragaloside capsule or a placebo capsule once daily. Aim to see if those taking astragaloside experience better mobility and fewer joint-related symptoms compared to those in the placebo group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this randomized, double-blind clinical trial is to investigate the efficacy of astragaloside supplementation in enhancing joint health and physical function among healthy individuals aged 20 to 70 years.

Study Design and Procedures: Participants will be randomized into two groups: the intervention group (astragaloside) and the control group (placebo). Each participant will be instructed to consume one capsule daily after a meal for 12 weeks.

The study aims to address the following objectives:

Physical Function Assessment: To evaluate changes in knee joint mobility and strength using the Single-Leg Step-Down (SLSD) test and Range of Motion (ROM) measurements.

Subjective Symptoms and Quality of Life: To assess improvements in knee-related symptoms through the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

Biological Markers: To analyze blood biomarkers related to joint health and systemic response.

Comparative analysis between the astragaloside and placebo groups will be conducted to determine the statistical significance of the supplement's impact on joint function and discomfort.

Study Type

Interventional

Enrollment (Actual)

50

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

  • Taiwan
      • Taichung, Taiwan, 402
        • Chung Shan Medical 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:

  • Healthy male or female adults, aged 18 to 75 years, with a body mass index (BMI) of 18-30 kg/m².
  • Actively participates in regular exercise, including but not limited to soccer, basketball, tennis, rugby, running, or cycling, and engages in at least two training sessions per week during the study period.
  • Experiences pain ≥5 on a Visual Analog Scale (VAS) during the Single-Leg Step-Down (SLSD) test when performing 30 to 150 steps.
  • Has experienced knee discomfort within the last 3 months during or after physical activity.

Exclusion Criteria:

  • Participation in another clinical trial within 30 days prior to study enrollment.
  • Uncontrolled diabetes or currently using insulin therapy.
  • Current smokers.
  • History of heart failure.
  • Previous bilateral knee replacement surgery.
  • Current use of prescription COX-2 inhibitors, chondroitin sulfate, glucosamine sulfate or hydrochloride, collagen, fish oil, or vitamin D supplements and unwilling to discontinue these during the study.
  • Likely to be lost to follow-up, non-compliant, or requiring concomitant medication that may interfere with study outcomes.
  • Received intra-articular treatment within 3 months prior to study start.
  • Medical conditions that may interfere with study results, such as cancer, cardiovascular disease (e.g., stroke, myocardial infarction), pregnancy, or breastfeeding.
  • Hip, spine, or foot injuries that could affect study outcomes.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astragaloside Group
200mg astragaloside
Dietary supplement: Astragaloside
Participants in the Astragaloside Group will receive one astragaloside capsule orally once daily after meals for 12 weeks. The capsule contains the active compound astragaloside, a component of the traditional herb Astragalus. Participants will be asked to continue their usual diet and physical activity levels during the study.
Placebo Comparator: Placebo Group
200mg maltodextrin
Dietary supplement: Maltodextrin (Placebo)
Participants in the Placebo Group will receive one maltodextrin capsule orally once daily after meals for 12 weeks. The capsule is identical in appearance to the astragaloside capsule but contains no active astragaloside. Participants will be asked to continue their usual diet and physical activity levels during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in knee joint stability via SLSD test at 12 weeks.
Time Frame: From baseline to Week 12
The SLSD test evaluates functional knee stability and lower extremity muscle strength. The examiner records the number of successful repetitions or a quality score based on trunk and limb alignment. Higher scores (or higher number of repetitions) indicate better functional stability and joint control.
From baseline to Week 12
Change from baseline in knee Range of Motion (ROM) at 12 weeks.
Time Frame: From baseline to Week 12
Knee ROM measures the degree of flexion and extension using a universal goniometer. The measurement is recorded in degrees. An increase in the range of degrees indicates improved joint mobility.
From baseline to Week 12
Change from baseline in KOOS score at 12 weeks.
Time Frame: From baseline to Week 12
The KOOS questionnaire consists of 5 subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-related Quality of Life (QOL). Standardized answer options are given (5-point Likert scale). Each subscale score is calculated as a percentage from 0 to 100. A score of 100 represents no knee problems and 0 represents extreme knee problems; therefore, a higher score indicates better outcomes.
From baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in serum inflammatory cytokine levels at 12 weeks.
Time Frame: From baseline to Week 12
This measure evaluates the systemic inflammatory response by analyzing the concentrations of Pro-inflammatory cytokines, including Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-1 beta (IL-1b), and Macrophage Inflammatory Protein-1 alpha (MIP1a). Blood samples will be analyzed using Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in these biomarker concentrations (measured in pg/mL) indicates a reduction in systemic or joint-related inflammation.
From baseline to Week 12
Change from baseline in cartilage turnover biomarkers at 12 weeks.
Time Frame: From baseline to Week 12

This measure assesses the balance between cartilage degradation and synthesis.

Degradation Markers: C-terminal telopeptide of type II collagen (CTX-II), Cartilage Oligomeric Matrix Protein (COMP), and Matrix Metalloproteinase-13 (MMP-13).

Synthesis Markers: Type II collagen markers (COL2a, PIIPC, and PIINP). Samples will be analyzed via ELISA. Lower levels of degradation markers and stable or higher levels of synthesis markers indicate improved cartilage health and reduced joint tissue breakdown.
From baseline to Week 12

Collaborators and Investigators

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

Sponsor

Chung Shan Medical University

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)

October 24, 2024

Primary Completion (Actual)

October 9, 2025

Study Completion (Actual)

October 9, 2025

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-24092

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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