Delayed Onset Muscle SorenessPhase 4NCT02157675
Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness
A Phase 4 study testing Polyherbal capsule in people with Delayed Onset Muscle Soreness, run by NewChapter, Inc. at 1 site in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled, crossover design study in healthy subjects to determine the effects of a polyherbal supplement on the signs and symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Polyherbal capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- be in good general health without clinically significant disease, as determined by medical history, physical examination, and urine drug screens
- body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- females of child bearing potential must agree to use appropriate birth control methods during the entire study period
- agree not to initiate any new exercise or diet programs during the entire study period
- agree not to change their current diet or exercise program during the entire study period
- understand the study procedures and sign the forms providing informed consent to participate in the study, and authorize the release of relevant protected health information of the study investigator
- agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial.
Who cannot join
- previous history of upper extremity injury or pain
- use of anti-inflammatory medications or pain medications beginning at the screening visit and during the study
- daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
- use of any immunosuppressive drugs or biologic products in the last 12 months (including steroids [except for inhaled and topical dose forms]);
- antibiotic use, anticoagulants, intra-articular steroids in past 3 months
- any significant GI condition that would potentially interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (ulcerative colitis or Crohn's), history of lap band surgery, history of perforation of the stomach or intestines, or gastroparesis
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- clinically significant renal, hepatic and biliary, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic (particularly balance or neuropathy problems), hematologic disorder, or significant mental health disorder
- known allergy or sensitivity to herbal ingredients in the test products, olive oil, or soy
- history or presence of cancer in the last 5 years (except basal cell carcinoma of skin or in-situ cervical cancer)
- recent history of (within 2 years) or strong potential for alcohol or substance abuse
- participation in a clinical study with exposure to any non-registered drug product within 30 days prior to this study
- report use of tobacco or products containing nicotine
- individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk, including subjects who are bed or wheelchair-bound or those who have any physical disability which could interfere with their ability to perform the exercise assessments included in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness: a 2-arm, Randomized, Double-blind, Placebo-controlled, Crossover Design Study
This study is a randomized, double-blind, placebo-controlled, crossover design study in healthy subjects to determine the effects of a polyherbal supplement on the signs and symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.
Read the detailed description
Approximately 30 subjects will be enrolled. The study includes a 19-day treatment period and a minimum 7-day washout period in which no test product is administered. Subjects will then crossover to a second 19-day treatment period to complete the study. Subjects receive test product (polyherbal capsule or placebo capsule) daily during the treatment periods. Two exercise test sessions followed up to 5 days will occur during the study using a modified seated arm-curl bench. Muscle strength is assessed on each day of the 5-day exercise test period. Safety is assessed during the study by collecting adverse events (AEs), clinical laboratory data (serum hematology and chemistry), and vital signs (blood pressure, pulse, respiration rate, temperature).
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Polyherbal capsule, Placebo capsule
- Keywords
- Delayed onset muscle soreness, Muscle damage, Eccentric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyherbal capsuleDietary supplement
Placebo capsuleDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Polyherbal capsule | Experimental | Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. Receives: Dietary Supplement: Polyherbal capsule |
| Placebo capsule | Placebo comparator | Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise.
This procedure utilizes 3 sets of 1 repetition of maximal isometric contractions of the arm recorded in pounds and averaged across the 3 sets.
Measured: Day 2 of each 5-day test period (ie, 48 hours after the eccentric exercise procedure to induce DOMS on Day 0)
Secondary outcomes (6)
Change from baseline in peak muscle strength after eccentric exercise
Measured: Up to 5 days following eccentric exercise.
Change from baseline in pain assessment after eccentric exercise
Pain will be assessed verbally during elbow flexion and extension using a 10-point Likert scale (with 1 = normal, no discomfort and 10 = very uncomfortable).
Measured: Days 1-4 of each test period after eccentric exercise
Change from baseline in flexibility after eccentric exercise
Flexibility of the biceps muscle group will be evaluated with the arm hanging freely at the subject's side. The relaxed extension will be measured using an electronic level and electronic goniometer placed at the elbow.
Measured: Days 1-4 of each test period after eccentric exercise
Change from baseline in elbow girth (swelling) after eccentric exercise
Girth measurements will be taken around the elbow.
Measured: Days 1-4 of each test period after eccentric exercise
Change from baseline in muscle tenderness after eccentric exercise
Muscle tenderness scores will be assessed using a standard manual muscle myometer. Decreasing force application after baseline indicates increasing tenderness, a reflection of muscle damage.
Measured: Days 1-4 of each test period after eccentric exercise
Change from baseline in creatinine kinase (CK) and C-reactive protein (CRP) levels after eccentric exercise
Measured: Days 1-4 of each test period after eccentric exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle SorenessStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewChapter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157675
- Sponsor's protocol ID
- NEWC2700
- Other IDs
- 2013138
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness: a 2-arm, Randomized, Double-blind, Placebo-controlled, Crossover Design Study
- ClinicalTrials.gov ID
- NCT02157675
- Acronym / sponsor ID
- NEWC2700
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- Delayed onset muscle soreness, Muscle damage, Eccentric exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NewChapter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jun 2014 (estimated)
- 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 is a randomized, double-blind, placebo-controlled, crossover design study in healthy subjects to determine the effects of a polyherbal supplement on the signs and symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.
Detailed description
Approximately 30 subjects will be enrolled. The study includes a 19-day treatment period and a minimum 7-day washout period in which no test product is administered. Subjects will then crossover to a second 19-day treatment period to complete the study. Subjects receive test product (polyherbal capsule or placebo capsule) daily during the treatment periods. Two exercise test sessions followed up to 5 days will occur during the study using a modified seated arm-curl bench. Muscle strength is assessed on each day of the 5-day exercise test period. Safety is assessed during the study by collecting adverse events (AEs), clinical laboratory data (serum hematology and chemistry), and vital signs (blood pressure, pulse, respiration rate, temperature).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyherbal capsule | Experimental | Dietary Supplement: Polyherbal capsuleSubjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo capsuleSubjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- be in good general health without clinically significant disease, as determined by medical history, physical examination, and urine drug screens
- body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- females of child bearing potential must agree to use appropriate birth control methods during the entire study period
- agree not to initiate any new exercise or diet programs during the entire study period
Key exclusion criteria (13 listed)
- previous history of upper extremity injury or pain
- use of anti-inflammatory medications or pain medications beginning at the screening visit and during the study
- daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
- use of any immunosuppressive drugs or biologic products in the last 12 months (including steroids [except for inhaled and topical dose forms]);
- antibiotic use, anticoagulants, intra-articular steroids in past 3 months
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 |
|---|---|---|
| Polyherbal capsule | Dietary supplement | Polyherbal capsule |
| Placebo capsule | Dietary supplement | Placebo capsule |
Primary outcome
Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise.
Time frame: Day 2 of each 5-day test period (ie, 48 hours after the eccentric exercise procedure to induce DOMS on Day 0)
This procedure utilizes 3 sets of 1 repetition of maximal isometric contractions of the arm recorded in pounds and averaged across the 3 sets.
6 secondary outcomes
Change from baseline in peak muscle strength after eccentric exercise
Time frame: Up to 5 days following eccentric exercise.
Change from baseline in pain assessment after eccentric exercise
Time frame: Days 1-4 of each test period after eccentric exercise
Change from baseline in flexibility after eccentric exercise
Time frame: Days 1-4 of each test period after eccentric exercise
Change from baseline in elbow girth (swelling) after eccentric exercise
Time frame: Days 1-4 of each test period after eccentric exercise
Change from baseline in muscle tenderness after eccentric exercise
Time frame: Days 1-4 of each test period after eccentric exercise
Change from baseline in creatinine kinase (CK) and C-reactive protein (CRP) levels after eccentric exercise
Time frame: Days 1-4 of each test period after eccentric exercise
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 14 Oct 2015.
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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 Phase 4 study testing Polyherbal capsule in people with Delayed Onset Muscle Soreness, run by NewChapter, Inc. at 1 site in United States.
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 8 inclusion and 13 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 14 Oct 2015. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise. (time frame: Day 2 of each 5-day test period (ie, 48 hours after the eccentric exercise procedure to induce DOMS on Day 0)). 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 14 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.