Polyherbal Capsule Formulation for Joint Health

NCT02157701 | Completed Phase 4

• 2 other identifiers: NEWC26002014020
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule compared to placebo capsule in improving exercise capacity and overall parameters of joint health.

Conditions

Knee Discomfort; Pain Physical Activity

Keywords

Dietary herbs; Polyherbal capsule; Functional exercise capacity; Joint health

Outcome Measures

Primary Outcomes (1)

• 6-minute Timed Walk Distance Test

  Subjects will walk up and down a hallway for 6 minutes after being instructed to walk as rapidly as possible within their comfort zone and without causing themselves any pain. Study personnel will time each subject with a stopwatch and measure the total distance travelled in the 6 minutes.

  Visit 6 (Day 90)

Secondary Outcomes (8)

• 6-minute timed walk distance test

  Visits 3 and 4 (Days 14 and 45, respectively)

• WOMAC pain questions

  Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)

• Patient Global Assessment (PGA)

  Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)

• WOMAC overall score

  Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).

• WOMAC physical function questions

  Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).

Study Arms (2)

Polyherbal capsule

EXPERIMENTAL

1 capsule taken with breakfast and 1 capsule with lunch. Capsules should be taken immediately prior to meals and not with carbonated beverages.

Dietary Supplement: Polyherbal capsule

Placebo capsule

PLACEBO COMPARATOR

1 capsule taken with breakfast and 1 capsule with lunch. Capsules should be taken 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: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 25 and ≤ 75 years of age with history of joint discomfort in at least 1 knee following daily activities but otherwise healthy
• body mass index (BMI) ≥ 25 and ≤ 40 kg/m2
• sum of ≥ 60 mm (based on 100-mm visual analog scale \[VAS\]) on the first 2 questions (ie, "How much pain have you had when walking on a flat surface?" "How much pain have you had when going up or down stairs?") of the WOMAC (Section A; Appendix 2)
• 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, or to use other dietary supplements other than the test product, 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.

You may not qualify if:

• use of NSAIDS during the study (however 81 mg of aspirin daily for cardioprotection is allowed)
• daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
• subjects with any history of chronic inflammatory disease, immune system disorder or auto-immune disorder including but not limited to the following: AIDS/HIV, ankylosing spondylitis, dermatomyositis, fibromyalgia, Grave's disease, Hashimoto's thyroiditis, lupus, multiple sclerosis, myasthenia gravis, pernicious anemia, systemic vasculitis conditions such as temporal arteritis, primary biliary cirrhosis, psoriasis, Raynaud's syndrome, rheumatoid arthritis, sarcoidosis, scleroderma including the CREST syndrome subset, Sjogren's syndrome, temporal arteritis, inflammatory bowel disease, vitiligo, or chronic infections such as Lyme disease, tuberculosis, endocarditis, and osteomyelitis;
• history of or current diagnosis of gout or pseudogout
• 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
• intra-articular hyaluronic acid in past 6 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, GI, endocrine (including diabetes mellitus), neurologic (particularly balance or neuropathy problems), or hematologic disorders; or chronic obstructive pulmonary disease (COPD), asthma, lung disease, or heart disease that limits exercise capacity (such as peripheral artery disease, ischemic heart disease, heart failure, stroke in the last year, or uncontrolled hypertension \[systolic blood pressure over 140 mmHg and/or diastolic above 90 mmHg\]) or causes abnormal respiratory or cardiovascular responses during the 6-minute timed walk distance test (such as angina or arrhythmias)
• known allergy or sensitivity to herbal ingredients in the test products, acetaminophen, 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) alcohol or substance abuse
• participation in a clinical study with exposure to any non-registered drug product within 30 days prior to this study
• 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 walk or perform the exercise capacity assessments included in this protocol (eg, history of knee or hip joint replacement surgery)
• diabetes not controlled by medication

Sponsors & Collaborators

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

Study Sites (5)

Akta Medika Medical Group Research Division

Homestead, Florida, 33030, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Radiant Research

Dallas, Texas, 75231, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Radiant Research

San Antonio, Texas, 78229, United States

Location

Study Officials

• Jose Brum, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

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

Study Record Dates

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

Record last verified: 2015-10

Locations

US (5)