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CompletedNCT07552675AD ASTRAUpdated Apr 30, 2026

Effects of Astragalus Membranaceus on Muscle Function

An interventional study of Astragalus Membranaceus and Placebo in Healthy Adult, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by University of Pavia · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Sep 2023, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

This study evaluated whether daily supplementation with Astragali radix extract (480 mg/day) for 10 weeks could attenuate training-induced impairments in muscle function, joint pain, and inflammatory markers in moderately active young adults undergoing a structured resistance training program. Participants were randomized in a double-blind, placebo-controlled design to receive either Astragali radix extract (ASTRA) or placebo (PLA) during 8 weeks of progressive resistance training followed by 2 weeks of intensified training. The primary outcome was maximal voluntary isometric torque (MVIT) of the knee extensors. Secondary outcomes included one-repetition maximum (1RM) strength, knee range of motion, muscle soreness (VAS), and circulating blood biomarkers of muscle damage and inflammation.

Read the detailed description

Background and Rationale Physical inactivity is associated with approximately 10% of premature deaths and an estimated €100 billion in annual healthcare costs. Current guidelines recommend at least 150 minutes of moderate-intensity aerobic activity per week alongside resistance training for optimal health. However, when the balance between training load and recovery is disturbed, athletes may develop non-functional overreaching (NFOR), a state of maladaptation characterized by adverse physiological, psychological, and functional outcomes requiring days to weeks for full resolution.

Astragali radix (Astragalus membranaceus), belonging to the Fabaceae family and officially included in the European Pharmacopoeia (8th ed.), is a traditional Chinese herbal medicine known for its antioxidant, anti-inflammatory, and immunomodulatory properties. Prior research has suggested potential benefits in reducing post-exercise inflammatory markers and improving aerobic performance, but its effects during prolonged, structured resistance training programs had not been systematically investigated.

Study Design This was a randomized, double-blind, placebo-controlled trial with 1:1 allocation. Twenty-four moderately active healthy young adults (mean age \~25 years; 13 males/11 females across groups) were enrolled after initial screening of 72 volunteers. Participants were randomly allocated to the ASTRA group (n=13) or PLA group (n=11). Randomization was performed using a computer-generated sequence.

Interventions Participants in the ASTRA group received 480 mg/day of Astragali radix hydroalcoholic extract (Axtragyl®, Giellepi S.p.A., Seregno, Italy; 2 capsules × 240 mg/day) for 10 weeks. The PLA group received matched capsules containing inert substances (microcrystalline cellulose, maltodextrin, magnesium salts of fatty acids) for the same period. Supplement compliance was monitored via daily text messages and collection of returned empty containers.

Training Protocol All participants performed a combined training intervention consisting of: (1) 8 weeks of regular resistance training (RT) at 3 sessions/week, with progressive overload targeting lower limb muscles (back squat, leg press, single-leg extension, single-leg curl, calf raises) at 70-80% of 1RM; followed by (2) 2 weeks of intensified training (IT) at 6 sessions/week, performing 10 sets of 1 repetition at 100% 1RM of leg press and leg extension. All sessions were supervised by experienced personnel.

Assessments

Testing was performed at three time points: baseline (BAS, one week before intervention), after 8 weeks of RT (48 hours post-last session), and after IT completion (24 hours post-last session). Assessments included:

Maximal voluntary isometric torque (MVIT) of knee extensors measured on a custom-built ergometer (primary outcome)

1RM of leg press and leg extension Knee range of motion (ROM) assessed by gyroscope-based goniometry during passive movement Muscle soreness via 100-mm visual analogue scale (VAS) Blood biomarkers: serum CPK, LDH, myoglobin, CRP, IL-6, TNF-α, IGF-1, cortisol, and testosterone (venous blood drawn at BAS, RT, and IT under standardized fasting conditions) Statistical Analysis A general linear model for repeated measures was used, with time (BAS, RT, IT) as within-subject factor and supplementation group (ASTRA vs. PLA) as between-subject factor. Post-hoc comparisons used Bonferroni correction. Effect sizes were reported as partial eta squared (η²). Statistical significance was set at p \< 0.05.

02

Conditions studied

  • Healthy Adult

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Keywords

  • Dietary supplementation
  • inflammation
  • muscle damage
  • force
  • non-functional overreaching
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Physical Activity Status: Moderately active, defined as a metabolic equivalent (MET) between 3 and 6 based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) (Bull et al., 2020).
  • Health Status: Non-smokers and free from cardiovascular, metabolic, and neurological diseases.

Exclusion criteria

Exclusion Criteria:

  • Injuries: any muscular, bone, or joint injuries sustained within the 6 months prior to the study.
  • Supplementation/Medication: A history of consuming dietary supplements or drugs within the 6 months preceding the intervention.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    ASTRA

    Dietary Supplement: Astragalus Membranaceus

  • Placebo comparator
    PLACEBO

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAstragalus Membranaceus

    480 mg daily of astragali radix extract for 10 weeks (2 capsules x day orally).

  • Dietary supplementPlacebo

    Capsules containing an inert substance identical by visual, taste, and smell to the active formulation but without any active ingredients

06

What researchers measure

Primary outcomes

  1. MVIT

    Maximal voluntary isometric torque

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.

Secondary outcomes

  1. ROM

    Range of Motion

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase

  2. Muscle soreness

    Subjects were asked to mark their pain level on the line under the supervision of the examiner while the knee joint was passively flexed and extended by the investigator.

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.

  3. Serum Creatine Phosphokinase

    Serum Creatine Phosphokinase

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.

  4. Interleukin-6 (IL-6)

    Interleukin-6 (IL-6)

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.

  5. Tumor necrosis factor-alpha (TNF-α)

    Tumor necrosis factor-alpha (TNF-α)

    Time frame: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.

07

Study locations

1 site
  • Università di Pavia
    Pavia, 27100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07552675
Lead sponsor
University of Pavia
Responsible party
Simone Porcelli (Associate Professor, University of Pavia) — Principal investigator
First posted
Apr 27, 2026
Start date
Sep 1, 2023
Primary completion
Dec 31, 2025
Completion
Feb 25, 2026
Last update
Apr 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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