Joint DiscomfortNCT04955353
Efficacy of a Hydrolyzed Chicken Collagen Type II in Alleviating Joint Discomfort
A study testing AVC-H2 in people with Joint Discomfort, run by Avicenna Nutraceutical at 1 site in United States.
Trial summary
Joint pain and disease affect more than one in four adults in the United States. We conducted a double-blind, randomized, placebo-controlled trial to investigate the efficacy of a hydrolyzed chicken collagen type II (HCII) supplement in reducing joint-related discomfort such as pain and stiffness, and in improving… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Discomfort
- What is being tested?
- AVC-H2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 12 Feb 2018
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women 40-65 years of age
- all races
- good general health (free of any systemic or dermatological disorder) but have joint pain, stiffness, or other joint-related discomfort
- literate and able to understand the informed consent document, as well as able to choose whether or not to sign the form
- able to complete a preliminary medical history, Health Insurance Portability and Accountability Act (HIPAA), and Code of Conduct form
- able to cooperate with the Investigator and research staff
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- willing and able to comply with the instructions to use the test product, and to complete the full course of the study
- agree to not participate in any other study during the entire duration of the study
- have not participated in a similar study in the past thirty days
- agree to refrain from using any joint-pain relief products except for the product received from our re-search staff during the entire duration of the study
- agree to take a urine pregnancy test prior to enrollment
Who cannot join
- individuals currently taking any medications that may mask or interfere with the test results
- those who had a history of any acute or chronic disease that would interfere with or increase the risk of study participation
- those with a history of diseases of chronic inflammation (e.g., septic arthritis, gout, and rheumatoid arthritis)
- those who had a recent injury in the hip, knee, and/or wrist in the past six months
- those who had a history of hip, knee, and/or wrist surgery
- those who had injections to reduce joint discomfort in the past 12 months
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- those who are at high risk of adverse outcomes for participating in the study and thus may invalidate the study due to confounding factors
- pregnancy or lactation
- individuals who had diabetes or hyperuricemia
- body mass index > 30 kg/m2
- history of substance abuse
- known history of hypersensitivity to any cosmetics, personal care products, or fragrances
- known allergy to eggs, chicken, or any other ingredients in the test product
- individuals who have phenylketonuria
- those who need to take calcium supplementation
- those who are affiliated with the clinical trial agency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of a Hydrolyzed Chicken Collagen Type II Supplement in Alleviating Joint Discomfort
Joint pain and disease affect more than one in four adults in the United States. We conducted a double-blind, randomized, placebo-controlled trial to investigate the efficacy of a hydrolyzed chicken collagen type II (HCII) supplement in reducing joint-related discomfort such as pain and stiffness, and in improving mobility. We enrolled adults aged 40-65y (65.5% were women) who had joint discomfort, but had no co-morbidities, and were not taking pain medications. The participants were randomized to receive either the HCII supplement (n=47) or a placebo (n=43) for eight weeks. At baseline, week 4, and week 8, we administered the Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with three additional wrist-related questions and the Visual Analog Scale for assessments of joint-related symptoms.
Read the detailed description
Joint pain and disease affects more than one in four adults in the United States. Hydrolyzed Chicken Collagen Type II, hereinafter referred to as HCII, may repair or regenerate deteriorating collagen, and therefore, help address the underlying cause of joint discomfort. This study evaluated the efficacy of Avicenna's patented Hydrolyzed Chicken Collagen Type II product, hereinafter referred to as AVC-H2, in the reduction of joint pain \& stiffness and improvement in joint function.
BioScreen Clinical Services conducted a double-blind, randomized, placebo-controlled trial. 90 participants were enrolled, 47 in the AVC-H2 group and 43 in the placebo group; aged 40-65 with overall joint discomfort but no co-morbidities were enrolled. Participants in both groups took two pills in the morning and evening for 8 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with the addition of 3 questions pertaining to the wrist and Visual Analog Scale (VAS) for pain assessment were conducted at baseline, week 4, and week 8.
The product used was Avicenna's Hydrolyzed Chicken Collagen Type II raw material product. The techniques used to create AVC-H2 mimic the body's natural hydrolysis process for ease of digestion and optimum low molecular weight. AVC-H2 protein consists of protein bonds that have been broken down or "untied" so that they are more easily absorbed by the small intestines. The total collagen in the product is ≥ 70%, making it a highly pure product, in comparison to other collagen products that were tested prior to the study. Total collagen content of AVC-H2 was based off of certificates of analyses prior to the study. As such, a smaller dosage was administered to participants compared to previous studies of similar products. Participants in the study were randomly assigned to receive either 2.5g of AVC-H2 daily or a matching amount of placebo.
Intent to Treat Analysis and Sensitivity Analysis were both used. Intent to Treat Analysis included all study participants and Sensitivity Analysis removed participants who broke protocol and those who initially claimed they had 0 joint pain \& stiffness.
To the investigators' knowledge, Avicenna's study appears to be the first to assess the efficacy of HCII on joint discomfort in the wrist and in individuals not taking additional pain medications.
- Conditions
- Joint Discomfort
- Being tested
- AVC-H2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVC-H2Dietary supplement
A total of 2.5g AVC-H2 daily (2 tablets in the morning and 2 in the evening)
PlaceboDietary supplement
A total of 2.5g placebo daily (2 tablets in the morning and 2 in the evening)
| Study group | Role | What they receive |
|---|---|---|
| AVC-H2 | Experimental | Participants received Avicenna Hydrolyzed Chicken Collagen Type II (AVC-H2), 2.5g daily, for 8 weeks. Receives: Dietary Supplement: AVC-H2 |
| Placebo | Placebo comparator | Participants received placebo of matching amount to that of AVC-H2 daily for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Baseline
The WOMAC survey is used to assess joint-related discomfort at baseline. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Measured: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Midpoint (Week 4)
The WOMAC survey is used to assess joint-related discomfort at midpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Measured: Week 4
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Endpoint (Week 8)
The WOMAC survey is used to assess joint-related discomfort at endpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Measured: Week 8
The Visual Analog Scale (VAS) - Baseline
VAS is used for pain assessment at baseline. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Measured: Baseline
The Visual Analog Scale (VAS) - Midpoint (Week 4)
VAS is used for pain assessment at midpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Measured: Week 4
The Visual Analog Scale (VAS) - Endpoint (Week 8)
VAS is used for pain assessment at endpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start16 Oct 2017
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Nutraceutical
- Sponsor type
- University, hospital or other
- Collaborators
- BioScreen Testing Services
- Responsible party
- Sponsor
- Investigators
- Rania Ibrahim, PhD, Principal investigator, BioScreen Testing Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955353
- Sponsor's protocol ID
- BCS 17-033
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of a Hydrolyzed Chicken Collagen Type II Supplement in Alleviating Joint Discomfort
- ClinicalTrials.gov ID
- NCT04955353
- Acronym / sponsor ID
- BCS 17-033
- Conditions
- Joint Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Avicenna NutraceuticalUniversity, hospital or other
- Collaborators
- BioScreen Testing Services
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 8 Jul 2021 (actual)
- 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.
Joint pain and disease affect more than one in four adults in the United States. We conducted a double-blind, randomized, placebo-controlled trial to investigate the efficacy of a hydrolyzed chicken collagen type II (HCII) supplement in reducing joint-related discomfort such as pain and stiffness, and in improving mobility. We enrolled adults aged 40-65y (65.5% were women) who had joint discomfort, but had no co-morbidities, and were not taking pain medications. The participants were randomized to receive either the HCII supplement (n=47) or a placebo (n=43) for eight weeks. At baseline, week 4, and week 8, we administered the Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with three additional wrist-related questions and the Visual Analog Scale for assessments of joint-related symptoms.
Detailed description
Joint pain and disease affects more than one in four adults in the United States. Hydrolyzed Chicken Collagen Type II, hereinafter referred to as HCII, may repair or regenerate deteriorating collagen, and therefore, help address the underlying cause of joint discomfort. This study evaluated the efficacy of Avicenna's patented Hydrolyzed Chicken Collagen Type II product, hereinafter referred to as AVC-H2, in the reduction of joint pain \& stiffness and improvement in joint function.
BioScreen Clinical Services conducted a double-blind, randomized, placebo-controlled trial. 90 participants were enrolled, 47 in the AVC-H2 group and 43 in the placebo group; aged 40-65 with overall joint discomfort but no co-morbidities were enrolled. Participants in both groups took two pills in the morning and evening for 8 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with the addition of 3 questions pertaining to the wrist and Visual Analog Scale (VAS) for pain assessment were conducted at baseline, week 4, and week 8.
The product used was Avicenna's Hydrolyzed Chicken Collagen Type II raw material product. The techniques used to create AVC-H2 mimic the body's natural hydrolysis process for ease of digestion and optimum low molecular weight. AVC-H2 protein consists of protein bonds that have been broken down or "untied" so that they are more easily absorbed by the small intestines. The total collagen in the product is ≥ 70%, making it a highly pure product, in comparison to other collagen products that were tested prior to the study. Total collagen content of AVC-H2 was based off of certificates of analyses prior to the study. As such, a smaller dosage was administered to participants compared to previous studies of similar products. Participants in the study were randomly assigned to receive either 2.5g of AVC-H2 daily or a matching amount of placebo.
Intent to Treat Analysis and Sensitivity Analysis were both used. Intent to Treat Analysis included all study participants and Sensitivity Analysis removed participants who broke protocol and those who initially claimed they had 0 joint pain \& stiffness.
To the investigators' knowledge, Avicenna's study appears to be the first to assess the efficacy of HCII on joint discomfort in the wrist and in individuals not taking additional pain medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVC-H2 | Experimental | Dietary Supplement: AVC-H2Participants received Avicenna Hydrolyzed Chicken Collagen Type II (AVC-H2), 2.5g daily, for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received placebo of matching amount to that of AVC-H2 daily for 8 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- men and women 40-65 years of age
- all races
- good general health (free of any systemic or dermatological disorder) but have joint pain, stiffness, or other joint-related discomfort
- literate and able to understand the informed consent document, as well as able to choose whether or not to sign the form
- able to complete a preliminary medical history, Health Insurance Portability and Accountability Act (HIPAA), and Code of Conduct form
Key exclusion criteria (16 listed)
- individuals currently taking any medications that may mask or interfere with the test results
- those who had a history of any acute or chronic disease that would interfere with or increase the risk of study participation
- those with a history of diseases of chronic inflammation (e.g., septic arthritis, gout, and rheumatoid arthritis)
- those who had a recent injury in the hip, knee, and/or wrist in the past six months
- those who had a history of hip, knee, and/or wrist surgery
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 |
|---|---|---|
| AVC-H2A total of 2.5g AVC-H2 daily (2 tablets in the morning and 2 in the evening) | Dietary supplement | AVC-H2 |
| PlaceboA total of 2.5g placebo daily (2 tablets in the morning and 2 in the evening) | Dietary supplement | Placebo |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Baseline
Time frame: Baseline
The WOMAC survey is used to assess joint-related discomfort at baseline. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Midpoint (Week 4)
Time frame: Week 4
The WOMAC survey is used to assess joint-related discomfort at midpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Endpoint (Week 8)
Time frame: Week 8
The WOMAC survey is used to assess joint-related discomfort at endpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).
The Visual Analog Scale (VAS) - Baseline
Time frame: Baseline
VAS is used for pain assessment at baseline. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
The Visual Analog Scale (VAS) - Midpoint (Week 4)
Time frame: Week 4
VAS is used for pain assessment at midpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
The Visual Analog Scale (VAS) - Endpoint (Week 8)
Time frame: Week 8
VAS is used for pain assessment at endpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.
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 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Rania Ibrahim, PhD principal investigator
BioScreen Testing Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVC-H2 in people with Joint Discomfort, run by Avicenna Nutraceutical 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 11 inclusion and 16 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 8 Jul 2021. 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.
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?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. 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 8 Jul 2021.