Healthy AdultAD ASTRANCT07552675
Effects of Astragalus Membranaceus on Muscle Function
A study testing Astragalus Membranaceus in people with Healthy Adult, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Astragalus Membranaceus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Astragalus Membranaceus Modulates Inflammatory Markers Without Enhancing Muscle Function Following Intensified Resistance Training
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.
- Conditions
- Healthy Adult
- Being tested
- Astragalus Membranaceus, Placebo
- Keywords
- Dietary supplementation, inflammation, muscle damage, force, non-functional overreaching
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astragalus MembranaceusDietary supplement
480 mg daily of astragali radix extract for 10 weeks (2 capsules x day orally).
PlaceboDietary supplement
Capsules containing an inert substance identical by visual, taste, and smell to the active formulation but without any active ingredients
| Study group | Role | What they receive |
|---|---|---|
| ASTRA | Experimental | Not described Receives: Dietary Supplement: Astragalus Membranaceus |
| PLACEBO | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVIT
Maximal voluntary isometric torque
Measured: 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 (5)
ROM
Range of Motion
Measured: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase
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.
Measured: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
Serum Creatine Phosphokinase
Serum Creatine Phosphokinase
Measured: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Measured: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
Tumor necrosis factor-alpha (TNF-α)
Tumor necrosis factor-alpha (TNF-α)
Measured: One week before the start of the intervention (BAS), 48 hours after RT phase, and 24 hours following the completion of IT phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Sep 2023
- Primary completion31 Dec 2025
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Porcelli, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552675
- Sponsor's protocol ID
- UNIPV0040463/23
- Acronym
- AD ASTRA
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astragalus Membranaceus Modulates Inflammatory Markers Without Enhancing Muscle Function Following Intensified Resistance Training
- ClinicalTrials.gov ID
- NCT07552675
- Acronym / sponsor ID
- AD ASTRA / UNIPV0040463/23
- Conditions
- Healthy Adult
- Keywords
- Dietary supplementation, inflammation, muscle damage, force, non-functional overreaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASTRA | Experimental | Dietary Supplement: Astragalus Membranaceus |
| PLACEBO | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astragalus Membranaceus480 mg daily of astragali radix extract for 10 weeks (2 capsules x day orally). | Dietary supplement | ASTRA |
| PlaceboCapsules containing an inert substance identical by visual, taste, and smell to the active formulation but without any active ingredients | Dietary supplement | PLACEBO |
Primary outcome
MVIT
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.
Maximal voluntary isometric torque
5 secondary outcomes
ROM
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
Muscle soreness
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astragalus Membranaceus in people with Healthy Adult, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVIT (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.