Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness

NCT02157675 | Completed Phase 4

• 2 other identifiers: NEWC27002013138
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delayed Onset Muscle Soreness

Keywords

Delayed onset muscle soreness; Muscle damage; Eccentric exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 5 days following eccentric exercise.

• Change from baseline in pain assessment after eccentric exercise

  Days 1-4 of each test period after eccentric exercise

• Change from baseline in flexibility after eccentric exercise

  Days 1-4 of each test period after eccentric exercise

• Change from baseline in elbow girth (swelling) after eccentric exercise

  Days 1-4 of each test period after eccentric exercise

• Change from baseline in muscle tenderness after eccentric exercise

  Days 1-4 of each test period after eccentric exercise

Study Arms (2)

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.

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.

Dietary Supplement: Placebo capsule

Interventions

Polyherbal capsule DIETARY_SUPPLEMENT

Polyherbal capsule

Placebo capsule DIETARY_SUPPLEMENT

Placebo capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NewChapter, Inc.: lead
• Procter and Gamble: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)