Knee DiscomfortPhase 4NCT02157701
Polyherbal Capsule Formulation for Joint Health
A Phase 4 study testing Polyherbal capsule in people with Knee Discomfort and Pain Physical Activity, run by NewChapter, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Knee Discomfort, Pain Physical Activity
- 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
- 108 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2014to Apr 2015
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Show all 23Show fewer
- intra-articular hyaluronic acid in past 6 months
- subjects with chronic pain syndrome and who are in the judgment of the Investigator unlikely to respond to any therapy (Note that chronic depression and chronic anxiety are known magnifiers of chronic pain syndrome and are also exclusionary. Chronic fatigue syndrome overlaps with the chronic pain domain and is also exclusionary. In addition, fibromyalgia is a central nervous system (CNS) disorder and overlaps with the chronic pain and chronic fatigue domains and is exclusionary as well.)
- 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
- untreated or unstable thyroid dysfunction (hyper- or hypo-thyroidism)
- subjects with a significant mental health disorder (bipolar disorder, chronic depression requiring medication, chronic anxiety disorder, obsessive compulsive disorder, or active eating disorders including anorexia nervosa or bulimia)
- subjects with a history of seizures in the last 5 years or dizziness when exercising
- knee arthroscopy in the previous year or surgeries of the lumbar spine, hip, knee, ankle or foot
- surgery scheduled prior to study completion
- pregnant or lactating women
- walk > 575 meters (1886 feet), or have a Knee Pain Rating Scale (Appendix 4) score of < 40 mm on a 100 mm VAS that assesses knee discomfort, after the 6-minute timed walk distance test.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Radiant Research
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Akta Medika Medical Group Research Division
Homestead, Florida, 33030
Benchmark Research
San Angelo, Texas, 76904
Radiant Research
San Antonio, Texas, 78229
About this study
Official title: Polyherbal Capsule Formulation for Joint Health: a Multicenter, 2-arm, Randomized, Double-blind, Placebo-controlled Study
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.
Read the detailed description
Subjects will come to the study site at Visit 1 for screening assessments (which will occur within 14 days before the start of the run-in period) and to answer questions associated with habitual diet, exercise capacity, and level of activity. Those subjects who meet initial inclusion/exclusion criteria will undergo a run-in period of at least 7 days at home to discontinue use of all concurrent dietary supplements. Subjects will then return to the study site at Visit 2 (Baseline; Day 0) for further assessments and those meeting all inclusion/exclusion criteria will be enrolled into the study and randomly assigned to study product.
Approximately 108 subjects (54 per treatment group) will be enrolled in the study. Subjects will be evaluated at Visit 3 (Day 14), Visit 4 (Day 45), Visit 5 (Day 60, phone call), and Visit 6 (Day 90). Exercise capacity (ie, 6-minute timed walk distance test) will be assessed, along with overall knee wellness and joint-related symptoms using WOMAC, PGA, Knee Pain Rating Scale, and rescue medication usage. Safety will be assessed by collecting adverse events (AEs) and clinical laboratory data.
- Conditions
- Knee Discomfort, Pain Physical Activity
- Being tested
- Polyherbal capsule, Placebo capsule
- Keywords
- Dietary herbs, Polyherbal capsule, Functional exercise capacity, Joint health
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 | 1 capsule taken with breakfast and 1 capsule with lunch. Capsules should be taken immediately prior to meals and not with carbonated beverages. Receives: 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. Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 6 (Day 90)
Secondary outcomes (8)
6-minute timed walk distance test
Measured: Visits 3 and 4 (Days 14 and 45, respectively)
WOMAC pain questions
WOMAC Index is a self-administered questionnaire that assesses 3 dimensions of pain, physical function, and joint stiffness in knee and hip osteoarthritis using a battery of 24 questions. The latest version of the instrument (WOMAC 3.1) in 100-mm VAS format will be used in this clinical study.
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
Patient Global Assessment (PGA)
PGA is a measurement tool to quantify disease activity that asks patients in 100-mm VAS format to rate on a scale how they feel overall.
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
WOMAC overall score
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC physical function questions
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC joint stiffness questions
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Knee Pain Rating Scale
A 100-mm VAS Pain Rating Scale will be used to assess knee discomfort after the 6-minute timed walk distance test, where 0 mm = "No Pain" and 100 mm = "Worst Possible Pain".
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Rescue medication usage
Acetaminophen will be permitted as rescue product during the treatment phase and at the end of the 6 minute timed walk distance test. Subjects will be advised to use rescue product only in case of unbearable pain and to restrict the use to a maximum of 4 tablets (2 g) per day.
Measured: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
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 startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewChapter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Jose Brum, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157701
- Sponsor's protocol ID
- NEWC2600
- Other IDs
- 2014020
- 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
- Polyherbal Capsule Formulation for Joint Health: a Multicenter, 2-arm, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02157701
- Acronym / sponsor ID
- NEWC2600
- Conditions
- Knee Discomfort, Pain Physical Activity
- Keywords
- Dietary herbs, Polyherbal capsule, Functional exercise capacity, Joint health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- NewChapter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (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 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.
Detailed description
Subjects will come to the study site at Visit 1 for screening assessments (which will occur within 14 days before the start of the run-in period) and to answer questions associated with habitual diet, exercise capacity, and level of activity. Those subjects who meet initial inclusion/exclusion criteria will undergo a run-in period of at least 7 days at home to discontinue use of all concurrent dietary supplements. Subjects will then return to the study site at Visit 2 (Baseline; Day 0) for further assessments and those meeting all inclusion/exclusion criteria will be enrolled into the study and randomly assigned to study product.
Approximately 108 subjects (54 per treatment group) will be enrolled in the study. Subjects will be evaluated at Visit 3 (Day 14), Visit 4 (Day 45), Visit 5 (Day 60, phone call), and Visit 6 (Day 90). Exercise capacity (ie, 6-minute timed walk distance test) will be assessed, along with overall knee wellness and joint-related symptoms using WOMAC, PGA, Knee Pain Rating Scale, and rescue medication usage. Safety will be assessed by collecting adverse events (AEs) and clinical laboratory data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyherbal capsule | Experimental | Dietary Supplement: Polyherbal capsule1 capsule taken with breakfast and 1 capsule with lunch. Capsules should be taken immediately prior to meals and not with carbonated beverages. |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo capsule1 capsule taken with breakfast and 1 capsule with lunch. Capsules should be taken immediately prior to meals and not with carbonated beverages. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (23 listed)
- 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])
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
6-minute Timed Walk Distance Test
Time frame: Visit 6 (Day 90)
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.
8 secondary outcomes
6-minute timed walk distance test
Time frame: Visits 3 and 4 (Days 14 and 45, respectively)
WOMAC pain questions
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
Patient Global Assessment (PGA)
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
WOMAC overall score
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC physical function questions
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC joint stiffness questions
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Knee Pain Rating Scale
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Rescue medication usage
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
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.
Jose Brum, MD study director
Procter and Gamble
5 sites 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 Knee Discomfort and Pain Physical Activity, run by NewChapter, Inc. at 5 sites 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 7 inclusion and 23 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 5 sites 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?
6-minute Timed Walk Distance Test (time frame: Visit 6 (Day 90)). 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.