MyalgiaPhase 1UELNCT06125002
Diosmin for Treatment of Delayed-onset Muscle Soreness (DOMS)
A Phase 1 study testing Diosmin750 in people with Myalgia, run by Sergio Marques Borghi at 1 site in Brazil.
Trial summary
The potential benefits of exercise for the treatment of chronic inflammatory diseases and pain have been well documented in the scientific literature. Psychiatric, neurological, metabolic and cardiovascular diseases are examples of conditions that impact the health and quality of life of the population. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myalgia
- What is being tested?
- Diosmin750
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2024to May 2024
- Phase
- Phase 1
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be within the pre-determined age range.
- Be able to perform the proposed intense dynamic exercise protocol.
Who cannot join
- Locomotor system dysfunctions.
- Use of analgesic/anti-inflammatory medication at the time of recruitment.
- Calorie-restricted diet or ergogenic supplementation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual de Londrina
Londrina, Paraná, 86057-970
Sergio M Borghi, Ph.D., +55 43 999189216, sborghi@uel.br
Fabiana C Barreiros, Graduate, +55 43 988322883 ext. Borghi, sergio_borghi@yahoo.com.br
About this study
Official title: Evaluation of the Prophylactic Effects of the Flavonoid Diosmin on Delayed-onset Muscle Soreness in Humans: a Randomized, Double-blinded and Placebo-controlled Single-center Clinical Trial
The potential benefits of exercise for the treatment of chronic inflammatory diseases and pain have been well documented in the scientific literature. Psychiatric, neurological, metabolic and cardiovascular diseases are examples of conditions that impact the health and quality of life of the population. Due to the effects provided by exercise, it can modify the natural course of these diseases. This concept is important to justify the efforts made by government bodies committed to promoting exercise, such as the WHO. However, the habitual practice of physical activity following the primary guidelines may be hampered by some factors, including those that support the physiological repercussions of exercise on the body, such as muscle pain. In this sense, an important complicating factor such as delayed-onset muscle soreness (DOMS), present in the post-exercise recovery period, can impair adherence and permanence in physical activity programs, thus representing a considerable barrier to exercise promotion. They can also severely impair the performance of high-level athletes. Flavonoids, present in plants, but also in foods of the human diet, are known to have several biological properties, including analgesic, anti-inflammatory, and antioxidant effects. Currently, there are still few studies that have evaluated the effects of flavonoids on the development and evolution of DOMS in humans.
Read the detailed description
Main objective:
- Analyze the potential effects of supplementation with the flavonoid diosmin on DOMS in humans (athletes from the women's five-a-side soccer team from the city of Londrina, Paraná State, Brazil), using the proposed intense dynamic exercise protocol.
Specific objectives:
- Evaluate whether treatment with the flavonoid diosmin reduces muscle pain induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin reduces systemic (serum) levels of total creatine phosphokinase (CFQ) and oxidative stress (lipid peroxidation and antioxidant capacity) induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin is capable of improving the reduction in muscular performance and impairment of balance induced by the intense dynamic exercise protocol.
The present project will be carried out through a randomized, double-blinded and placebo-controlled clinical study. A total of approximately 40 female athletes pertaining to the Londrina Esporte Clube (name in Portuguese of the team) women's five-a-side soccer will be recruited for the study. The choice of exclusively women individuals is due to sexual dimorphism in pain perception, thus contributing to the results being more homogeneous and reliable. The criteria for inclusion of volunteer participants in the project will be to be between 16 and 35 years old, and to be able to perform the proposed intense dynamic exercise protocol. Exclusion criteria will include locomotor system dysfunctions or use of analgesic/anti-inflammatory medication at the time of recruitment, as well as being on a calorie-restricted diet or ergogenic supplementation. The study will consist of two experimental groups, made up of healthy individuals, who will perform the proposed intense dynamic exercise protocol, as follows: 1) control group that will receive placebo supplementation (corn starch tablets at a concentration of 750 mg); and 2) intervention group that will receive supplementation with diosmin (tablets at a concentration of 750 mg). Treatment of study participants will occur orally, and everyone will ingest identical opaque capsules containing placebo or diosmin with water. The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. Each experimental group will consist of approximately 20 participants. The project is approved by the Research Ethics Committee (CEP) for Human Beings/Brazil Platform(protocol number 64025122.2.0000.0108). The selected participants will be informed about the objectives and methodology of the study and when there is agreement with the proposed design, the agreement to voluntarily participate in the study will be registered by means of an Informed Consent Form. The intense dynamic exercise modality proposed (concentric and eccentric contractions) for the study will follow the following approach: participants will perform a standardized muscle injury protocol that will consist of a sequence of three sets of repetitions until fatigue of bilateral muscle contractions on a leg-press machine with a 45° angle. Each The participant will have their load previously defined through the 1 repetition maximum (1RM) test, and 70% of the defined weight will be used during the intense dynamic exercise protocol. During each action, the load will be resisted with the legs placed on the leg-press supporter from full knee extension to the 90° knee flexion angle, lasting approximately 3-5 seconds. Between each series, participants will be able to take a 1-minute rest period. The intense dynamic exercise protocol that will be carried out by all participants will be supervised by the project manager and/or collaborators duly trained for such assessments. Participants' clinical signs will be monitored frequently during the activities and in case of discomfort, the activity will be stopped immediately. Analyzes of clinical and blood parameters will be carried out before the start (baseline) and after the end of the proposed intense dynamic exercise protocol (24 and 48 hours) aiming to investigate the possible effects of diosmin on DOMS and related pathological events.
- Conditions
- Myalgia
- Being tested
- Diosmin750, Placebo
- Keywords
- delayed-onset muscle soreness, DOMS, exercise, flavonoids, diosmin
- Medical subject headings
- Myalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diosmin750Drug
Also called Diosmine
The ingestion will occur orally, under monitoring by the responsible investigator.
PlaceboDrug
Also called Corn starch tablets
The ingestion will occur orally, under monitoring by the responsible investigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (placebo, corn starch tablets) | Experimental | Treatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg). The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. Receives: Drug: Placebo |
| Intervention (diosmin) | Experimental | Treatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg). The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. Receives: Drug: Diosmin750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle soreness
Evaluated by both digital algometer (in kilograms force; Kgf) and visual analogue (VAS) scale (in centimeters; cm), where 0 represents no pain and 10 the worst possible pain.
Measured: Basal, 24, and 48 hours after DOMS induction protocol
Secondary outcomes (6)
Muscle tissue damage through the evaluation of the creatine phosphokinase (CPK) levels.
Evaluated by spectrophotometric analysis using commercial kits (in milligram per liter; mg/L)
Measured: Basal, 24, and 48 hours after DOMS induction protocol
Plasmatic lipid peroxidation levels
Evaluated by spectrophotometric analysis (in micromol per liter; µmol/L).
Measured: Basal, 24, and 48 hours after DOMS induction protocol
Plasmatic total antioxidant status
Evaluated by spectrophotometric analysis (in millimol per liter; mmol/L).
Measured: Basal, 24, and 48 hours after DOMS induction protocol
Recovery of muscle function through the evaluation of the average and maximum torque of the knee extension for determining quadriceps strength (maximum voluntary isometric contraction; MVIC).
Evaluated by isometric dynamometer (flexor/extension chair, in newton per meter; N/m).
Measured: Basal, 24, and 48 hours after DOMS induction protocol
Recovery of muscle function through vertical jump height.
Evaluated by jump strength (in milliseconds; msec).
Measured: Basal, 24, and 48 hours after DOMS induction protocol.
Bipedal and single-legged (unipedal) postural balance.
Evaluated through the antero-posterior (AP) and mediolateral (ML) displacement velocities (in centimeter per seconds; cm/sec).
Measured: Basal, 24, and 48 hours after DOMS induction protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyalgiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergio Marques Borghi
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Norte do Paraná
- Responsible party
- Sponsor-investigator, Sergio Marques Borghi, Universidade Estadual de Londrina
- Investigators
- Sergio M Borghi, Principal investigator, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125002
- Sponsor's protocol ID
- 64025122.2.0000.0108
- Acronym
- UEL
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luque MZ, Aguiar AF, da Silva-Araujo AK, Zaninelli TH, Heintz OK, Saraiva-Santos T, Bertozzi MM, Souza NA, Junior EO, Verri WA Jr, Borghi SM. Evaluation of a preemptive intervention regimen with hesperidin methyl chalcone in delayed-onset muscle soreness in young adults: a randomized, double-blinded, and placebo-controlled trial study. Eur J Appl Physiol. 2023 Sep;123(9):1949-1964. doi: 10.1007/s00421-023-05207-2. Epub 2023 Apr 29.
PubMed 37119360Borghi SM, Zaninelli TH, Saraiva-Santos T, Bertozzi MM, Cardoso RDR, Carvalho TT, Ferraz CR, Camilios-Neto D, Cunha FQ, Cunha TM, Pinho-Ribeiro FA, Casagrande R, Verri WA Jr. Brief research report: Repurposing pentoxifylline to treat intense acute swimming-Induced delayed-onset muscle soreness in mice: Targeting peripheral and spinal cord nociceptive mechanisms. Front Pharmacol. 2023 Jan 10;13:950314. doi: 10.3389/fphar.2022.950314. eCollection 2022.
PubMed 36703752Bussulo SKD, Ferraz CR, Carvalho TT, Verri WA Jr, Borghi SM. Redox interactions of immune cells and muscle in the regulation of exercise-induced pain and analgesia: implications on the modulation of muscle nociceptor sensory neurons. Free Radic Res. 2021 Jul;55(7):757-775. doi: 10.1080/10715762.2021.1953696. Epub 2021 Jul 19.
PubMed 34238089Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692Heiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, Huttel M, Hotfiel T. Advances in Delayed-Onset Muscle Soreness (DOMS) - Part II: Treatment and Prevention. Sportverletz Sportschaden. 2019 Mar;33(1):21-29. doi: 10.1055/a-0810-3516. Epub 2019 Mar 13.
PubMed 30865998da Cunha FCB, Cortez GB, Pucci IM, Silva MM, Borim JM, Bertozzi MM, Jacinto JL, Carvalho TT, Aguiar AF, Casonatto J, Junior EO, Verri WA Jr, Borghi SM. Effects of the Flavonoid Diosmin on Post Exercise Muscle Soreness - A Randomized Controlled Trial. J Diet Suppl. 2025;22(6):977-998. doi: 10.1080/19390211.2025.2547167. Epub 2025 Aug 16.
PubMed 40818103
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prophylactic Effects of the Flavonoid Diosmin on Delayed-onset Muscle Soreness in Humans: a Randomized, Double-blinded and Placebo-controlled Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT06125002
- Acronym / sponsor ID
- UEL / 64025122.2.0000.0108
- Conditions
- Myalgia
- Keywords
- delayed-onset muscle soreness, DOMS, exercise, flavonoids, diosmin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sergio Marques BorghiUniversity, hospital or other
- Collaborators
- Universidade Norte do Paraná
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
The potential benefits of exercise for the treatment of chronic inflammatory diseases and pain have been well documented in the scientific literature. Psychiatric, neurological, metabolic and cardiovascular diseases are examples of conditions that impact the health and quality of life of the population. Due to the effects provided by exercise, it can modify the natural course of these diseases. This concept is important to justify the efforts made by government bodies committed to promoting exercise, such as the WHO. However, the habitual practice of physical activity following the primary guidelines may be hampered by some factors, including those that support the physiological repercussions of exercise on the body, such as muscle pain. In this sense, an important complicating factor such as delayed-onset muscle soreness (DOMS), present in the post-exercise recovery period, can impair adherence and permanence in physical activity programs, thus representing a considerable barrier to exercise promotion. They can also severely impair the performance of high-level athletes. Flavonoids, present in plants, but also in foods of the human diet, are known to have several biological properties, including analgesic, anti-inflammatory, and antioxidant effects. Currently, there are still few studies that have evaluated the effects of flavonoids on the development and evolution of DOMS in humans.
Detailed description
Main objective:
- Analyze the potential effects of supplementation with the flavonoid diosmin on DOMS in humans (athletes from the women's five-a-side soccer team from the city of Londrina, Paraná State, Brazil), using the proposed intense dynamic exercise protocol.
Specific objectives:
- Evaluate whether treatment with the flavonoid diosmin reduces muscle pain induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin reduces systemic (serum) levels of total creatine phosphokinase (CFQ) and oxidative stress (lipid peroxidation and antioxidant capacity) induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin is capable of improving the reduction in muscular performance and impairment of balance induced by the intense dynamic exercise protocol.
The present project will be carried out through a randomized, double-blinded and placebo-controlled clinical study. A total of approximately 40 female athletes pertaining to the Londrina Esporte Clube (name in Portuguese of the team) women's five-a-side soccer will be recruited for the study. The choice of exclusively women individuals is due to sexual dimorphism in pain perception, thus contributing to the results being more homogeneous and reliable. The criteria for inclusion of volunteer participants in the project will be to be between 16 and 35 years old, and to be able to perform the proposed intense dynamic exercise protocol. Exclusion criteria will include locomotor system dysfunctions or use of analgesic/anti-inflammatory medication at the time of recruitment, as well as being on a calorie-restricted diet or ergogenic supplementation. The study will consist of two experimental groups, made up of healthy individuals, who will perform the proposed intense dynamic exercise protocol, as follows: 1) control group that will receive placebo supplementation (corn starch tablets at a concentration of 750 mg); and 2) intervention group that will receive supplementation with diosmin (tablets at a concentration of 750 mg). Treatment of study participants will occur orally, and everyone will ingest identical opaque capsules containing placebo or diosmin with water. The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. Each experimental group will consist of approximately 20 participants. The project is approved by the Research Ethics Committee (CEP) for Human Beings/Brazil Platform(protocol number 64025122.2.0000.0108). The selected participants will be informed about the objectives and methodology of the study and when there is agreement with the proposed design, the agreement to voluntarily participate in the study will be registered by means of an Informed Consent Form. The intense dynamic exercise modality proposed (concentric and eccentric contractions) for the study will follow the following approach: participants will perform a standardized muscle injury protocol that will consist of a sequence of three sets of repetitions until fatigue of bilateral muscle contractions on a leg-press machine with a 45° angle. Each The participant will have their load previously defined through the 1 repetition maximum (1RM) test, and 70% of the defined weight will be used during the intense dynamic exercise protocol. During each action, the load will be resisted with the legs placed on the leg-press supporter from full knee extension to the 90° knee flexion angle, lasting approximately 3-5 seconds. Between each series, participants will be able to take a 1-minute rest period. The intense dynamic exercise protocol that will be carried out by all participants will be supervised by the project manager and/or collaborators duly trained for such assessments. Participants' clinical signs will be monitored frequently during the activities and in case of discomfort, the activity will be stopped immediately. Analyzes of clinical and blood parameters will be carried out before the start (baseline) and after the end of the proposed intense dynamic exercise protocol (24 and 48 hours) aiming to investigate the possible effects of diosmin on DOMS and related pathological events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (placebo, corn starch tablets) | Experimental | Drug: PlaceboTreatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg). The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. |
| Intervention (diosmin) | Experimental | Drug: Diosmin750Treatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg). The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Be within the pre-determined age range.
- Be able to perform the proposed intense dynamic exercise protocol.
Key exclusion criteria (3 listed)
- Locomotor system dysfunctions.
- Use of analgesic/anti-inflammatory medication at the time of recruitment.
- Calorie-restricted diet or ergogenic supplementation.
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 |
|---|---|---|
| Diosmin750Also: DiosmineThe ingestion will occur orally, under monitoring by the responsible investigator. | Drug | Intervention (diosmin) |
| PlaceboAlso: Corn starch tabletsThe ingestion will occur orally, under monitoring by the responsible investigator. | Drug | Intervention (placebo, corn starch tablets) |
Primary outcome
Muscle soreness
Time frame: Basal, 24, and 48 hours after DOMS induction protocol
Evaluated by both digital algometer (in kilograms force; Kgf) and visual analogue (VAS) scale (in centimeters; cm), where 0 represents no pain and 10 the worst possible pain.
6 secondary outcomes
Muscle tissue damage through the evaluation of the creatine phosphokinase (CPK) levels.
Time frame: Basal, 24, and 48 hours after DOMS induction protocol
Plasmatic lipid peroxidation levels
Time frame: Basal, 24, and 48 hours after DOMS induction protocol
Plasmatic total antioxidant status
Time frame: Basal, 24, and 48 hours after DOMS induction protocol
Recovery of muscle function through the evaluation of the average and maximum torque of the knee extension for determining quadriceps strength (maximum voluntary isometric contraction; MVIC).
Time frame: Basal, 24, and 48 hours after DOMS induction protocol
Recovery of muscle function through vertical jump height.
Time frame: Basal, 24, and 48 hours after DOMS induction protocol.
Bipedal and single-legged (unipedal) postural balance.
Time frame: Basal, 24, and 48 hours after DOMS induction protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 37119360Luque MZ, Aguiar AF, da Silva-Araujo AK, Zaninelli TH, Heintz OK, Saraiva-Santos T, Bertozzi MM, Souza NA, Junior EO, Verri WA Jr, Borghi SM. Evaluation of a preemptive intervention regimen with hesperidin methyl chalcone in delayed-onset muscle soreness in young adults: a randomized, double-blinded, and placebo-controlled trial study. Eur J Appl Physiol. 2023 Sep;123(9):1949-1964. doi: 10.1007/s00421-023-05207-2. Epub 2023 Apr 29.
- Background: PubMed 36703752Borghi SM, Zaninelli TH, Saraiva-Santos T, Bertozzi MM, Cardoso RDR, Carvalho TT, Ferraz CR, Camilios-Neto D, Cunha FQ, Cunha TM, Pinho-Ribeiro FA, Casagrande R, Verri WA Jr. Brief research report: Repurposing pentoxifylline to treat intense acute swimming-Induced delayed-onset muscle soreness in mice: Targeting peripheral and spinal cord nociceptive mechanisms. Front Pharmacol. 2023 Jan 10;13:950314. doi: 10.3389/fphar.2022.950314. eCollection 2022.
- Background: PubMed 34238089Bussulo SKD, Ferraz CR, Carvalho TT, Verri WA Jr, Borghi SM. Redox interactions of immune cells and muscle in the regulation of exercise-induced pain and analgesia: implications on the modulation of muscle nociceptor sensory neurons. Free Radic Res. 2021 Jul;55(7):757-775. doi: 10.1080/10715762.2021.1953696. Epub 2021 Jul 19.
- Background: PubMed 12617692Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- Background: PubMed 30865998Heiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, Huttel M, Hotfiel T. Advances in Delayed-Onset Muscle Soreness (DOMS) - Part II: Treatment and Prevention. Sportverletz Sportschaden. 2019 Mar;33(1):21-29. doi: 10.1055/a-0810-3516. Epub 2019 Mar 13.
- Derived from this study: PubMed 40818103da Cunha FCB, Cortez GB, Pucci IM, Silva MM, Borim JM, Bertozzi MM, Jacinto JL, Carvalho TT, Aguiar AF, Casonatto J, Junior EO, Verri WA Jr, Borghi SM. Effects of the Flavonoid Diosmin on Post Exercise Muscle Soreness - A Randomized Controlled Trial. J Diet Suppl. 2025;22(6):977-998. doi: 10.1080/19390211.2025.2547167. Epub 2025 Aug 16.
- 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.
Sergio M Borghi principal investigator
Universidade Estadual de Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diosmin750 in people with Myalgia, run by Sergio Marques Borghi at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio M Borghi, Ph.D. (+55 43 999189216, sborghi@uel.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle soreness (time frame: Basal, 24, and 48 hours after DOMS induction protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125002, which also lists 6 linked publications.
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 9 Nov 2023.