Delayed Onset Muscle Soreness | Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness
Delayed Onset Muscle Soreness research study
What is the primary objective of this 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.
Who is eligible to participate?
Inclusion Criteria: - ≥ 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. Exclusion Criteria: - 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 - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Delayed Onset Muscle Soreness
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Polyherbal capsule
Dietary Supplement:Placebo capsule
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
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 capsuleSubjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages.
Start Date: April 2014
Completed Date: June 2014
Phase: Phase 4
Primary Outcome: Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise.
Secondary Outcome: Change from baseline in peak muscle strength after eccentric exercise
Study sponsors, principal investigator, and references
Lead Sponsor: NewChapter, Inc.
Collaborator: Procter and Gamble