NCT07382622

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in knee joint stability via SLSD test at 12 weeks.

    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.

    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.

    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 Outcomes (2)

  • Change from baseline in serum inflammatory cytokine levels at 12 weeks.

    From baseline to Week 12

  • Change from baseline in cartilage turnover biomarkers at 12 weeks.

    From baseline to Week 12

Study Arms (2)

Astragaloside Group

EXPERIMENTAL

200mg astragaloside

Dietary Supplement: Astragaloside

Placebo Group

PLACEBO COMPARATOR

200mg maltodextrin

Dietary Supplement: Maltodextrin (Placebo)

Interventions

AstragalosideDIETARY_SUPPLEMENT

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.

Astragaloside Group
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

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.

Placebo Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

MeSH Terms

Interventions

maltodextrin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start

October 24, 2024

Primary Completion

October 9, 2025

Study Completion

October 9, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations