<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470336</url>
  </required_header>
  <id_info>
    <org_study_id>JHB/190702/NATIVECTII/OA</org_study_id>
    <nct_id>NCT04470336</nct_id>
  </id_info>
  <brief_title>To Assess the Efficacy of Collagen Supplement in Osteoarthritis</brief_title>
  <official_title>A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vedic Lifesciences Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vedic Lifesciences Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Collagen Supplement is a natural ingredient that contains undenatured collagen derived from&#xD;
      chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and&#xD;
      efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee&#xD;
      Osteoarthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of&#xD;
      cartilage in movable joints that leads to friction between bones creating pain, stiffness,&#xD;
      and abnormal movement. It is estimated to affect more than 20% of the population over the age&#xD;
      of 60 years and is considered to be a major cause of morbidity, disability, and limitations&#xD;
      on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA&#xD;
      being 2nd most common rheumatological disorder. , As global life expectancy increases, the&#xD;
      prevalence of OA is expected to rise further ultimately resulting in a greater burden for&#xD;
      healthcare. Currently, the management has largely been palliative, focusing on the&#xD;
      alleviation of symptoms.&#xD;
&#xD;
      The principles of OA treatments primarily are to alleviate pain and stiffness and maintain&#xD;
      function. The current treatment guidelines recommend a combination of physical therapy, use&#xD;
      of analgesia with Acetaminophen or NSAIDs, and surgical intervention when deemed necessary.&#xD;
      While medications slow the progression of OA and other inflammatory conditions, no proven&#xD;
      disease-modifying agents for the treatment of knee OA currently exists. The majority of&#xD;
      individuals are successfully managed with a combination of the aforementioned treatments, but&#xD;
      there is still a significant group of patients in whom these treatments do not provide&#xD;
      adequate relief. Furthermore, there remains a lack of treatments that have demonstrated&#xD;
      effectiveness in stopping or reversing the degenerative process. , Besides, there are&#xD;
      considerable side effects associated with the use of these drugs. As a result, OA sufferers&#xD;
      have turned to natural nutraceuticals to ease their pain and discomfort.&#xD;
&#xD;
      In recent years, several novel agents have emerged as potential treatment alternatives to&#xD;
      improve pain, stiffness, and function with the possibility of altering disease progression.&#xD;
      These products are commonly used because they are well tolerated and considered safe. Among&#xD;
      the OA patients, glucosamine and chondroitin are most commonly used and have shown to&#xD;
      considerably reduce the pain associated with arthritis. From the nutraceutical point of view,&#xD;
      there is a growing interest in Collagen Supplement as a solution for the treatment of OA. The&#xD;
      Collagen Supplement has been studied extensively in both animals as well as human clinical&#xD;
      studies. , Among animal studies, a study in the rat model of OA reported several benefits&#xD;
      after treatment, suggesting its potential for the prevention of worsening of articular&#xD;
      cartilage damage. In another study, porcine Collagen Supplement administration demonstrated a&#xD;
      significant reduction of pain intensity. Also, a lower dose regimen showed meaningful pain&#xD;
      reduction indicating its protective effect on the cartilage. Furthermore, several studies&#xD;
      have evaluated the efficacy and safety of Collagen Supplement in individuals suffering from&#xD;
      chronic OA. Crowley and colleagues showed that supplementation of Collagen Supplement for&#xD;
      three months is more efficacious as compared to the combination of glucosamine plus&#xD;
      chondroitin. In another study, 6-month administration of the Collagen Supplement&#xD;
      significantly reduced pain, stiffness, and physical functioning as compared to glucosamine&#xD;
      hydrochloride plus chondroitin sulfate group of participants with knee OA.&#xD;
&#xD;
      Based on the available evidence it is clear that Collagen Supplement is effective in&#xD;
      improving joint discomfort associated with OA. Moreover, collagen products are also&#xD;
      recognized as safe components of pharmaceutical and foods by the US Food and Drugs&#xD;
      Administration Center for Food Safety and Nutrition. Hence, considering its symptomatic&#xD;
      benefits, the structural effect on the cartilage and its important role in bone structure,&#xD;
      Collagen Supplement is thought to be a viable alternative for OA patients. , Therefore, the&#xD;
      present study aimed to evaluate the safety and efficacy of an collagen supplementation in&#xD;
      participants suffering from knee OA. Study volunteers will be supplemented with Collagen&#xD;
      Supplement, an collagen product for 12 weeks and assessed as per study designated efficacy&#xD;
      and safety variables. Also, the efficacy and efficacy of Collagen Supplement will be compared&#xD;
      with Glucosamine HCL plus chondroitin sulfate and placebo as per the set study intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">April 12, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>modified Western Ontario and McMaster Score</measure>
    <time_frame>Day0 Day 28 Day 56 Day 84</time_frame>
    <description>Effect of consumption of IP on Joint health as assessed by the change in the (mWOMAC) total score from baseline and when compared with the placebo. [From baseline to 84 days] High score defines worst outcome and low score defines better oucome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>Day 0 and Day 84</time_frame>
    <description>Effect of consumption of IP on Joint health as assessed by the change in the EQ-5D-5L from baseline and when compared with the placebo. [From baseline to 84 days]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL - 6)</measure>
    <time_frame>Day 0 Day 84</time_frame>
    <description>Effect of consumption of IP on Joint inflammation as assessed by the change in the inflammatory biomarker interleukin-6 (IL-6) concentration from baseline and when compared with the placebo. [From baseline to 84 days]</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Collagen Supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucosamine chondroitin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collagen Supplement</intervention_name>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
    <arm_group_label>Collagen Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucosamine chondroitin</intervention_name>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
    <arm_group_label>Glucosamine chondroitin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Three capsules post-breakfast Three capsules post-dinner</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male &amp; female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3&#xD;
             months prior to screening.&#xD;
&#xD;
          -  BMI ≥ 18.5 and ≤ 29.9 kg/m2.&#xD;
&#xD;
          -  Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef&#xD;
             or eggs).&#xD;
&#xD;
          -  Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.&#xD;
&#xD;
          -  Radiographic evidence of grade II/III knee OA based on one of following criteria.&#xD;
&#xD;
          -  Participants willing to stop the restricted supplements and medications prior to&#xD;
             inclusion and throughout the study period.&#xD;
&#xD;
          -  Participants willing to stop any home-based remedies or any other form of topical&#xD;
             products intended for knee joint pain relief or any other reason for the entire study&#xD;
             duration.&#xD;
&#xD;
          -  Willing to stop the use of study designated rescue medication 48 hours prior to all&#xD;
             assessment visits.&#xD;
&#xD;
          -  Willing to abstain from food containing type II collagen only from cartilage, e.g.&#xD;
             chicken, fish, beef, pork, etc. 48 hours prior to all assessment visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders,&#xD;
             etc.), abnormal medical history or physical findings.&#xD;
&#xD;
          -  Participants with history of type II diabetes and uncontrolled hypertension.&#xD;
&#xD;
          -  Fasting Blood glucose &gt; 125 mg/dl&#xD;
&#xD;
          -  Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.&#xD;
&#xD;
          -  Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria&#xD;
             for osteoarthritis.&#xD;
&#xD;
          -  Any history of trauma, fractures or surgery to the index joint.&#xD;
&#xD;
          -  Any planned surgery (diagnostic or therapeutic intervention) to the index joint during&#xD;
             the participation in the study.&#xD;
&#xD;
          -  Participants with deformity of the knee joint.&#xD;
&#xD;
          -  Participants with a diagnosed condition which may involve or involves the index joint&#xD;
             that includes but is not limited to known rheumatic or inflammatory conditions such as&#xD;
             rheumatoid arthritis, osteomyelitis, osteoporosis, gout, and bone metastasis.&#xD;
&#xD;
          -  Other pathologic lesions on X-rays of the knee.&#xD;
&#xD;
          -  Current smokers or chronic alcoholics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Shalini Srivastava, MD - Med.</last_name>
    <role>Study Director</role>
    <affiliation>Vedic Life Sciences Pvt. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Randive's knee and spine clinic</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400093</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PKC Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400705</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Sonawane orthopedic clinic</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400709</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainbow Multispeciality hospital and trauma center</name>
      <address>
        <city>Navi Mumbai</city>
        <state>Maharashtra</state>
        <zip>400708</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shubham Sudbhawana Super Specialty Hospital</name>
      <address>
        <city>Varanasi</city>
        <state>Uttar Pradesh</state>
        <zip>221005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470336
org study id: JHB/190702/NATIVECTII/OA
nct id: NCT04470336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Collagen Supplement is a natural ingredient that contains undenatured collagen derived from
      chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and
      efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee
      Osteoarthritis
Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of
      cartilage in movable joints that leads to friction between bones creating pain, stiffness,
      and abnormal movement. It is estimated to affect more than 20% of the population over the age
      of 60 years and is considered to be a major cause of morbidity, disability, and limitations
      on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA
      being 2nd most common rheumatological disorder. , As global life expectancy increases, the
      prevalence of OA is expected to rise further ultimately resulting in a greater burden for
      healthcare. Currently, the management has largely been palliative, focusing on the
      alleviation of symptoms.

      The principles of OA treatments primarily are to alleviate pain and stiffness and maintain
      function. The current treatment guidelines recommend a combination of physical therapy, use
      of analgesia with Acetaminophen or NSAIDs, and surgical intervention when deemed necessary.
      While medications slow the progression of OA and other inflammatory conditions, no proven
      disease-modifying agents for the treatment of knee OA currently exists. The majority of
      individuals are successfully managed with a combination of the aforementioned treatments, but
      there is still a significant group of patients in whom these treatments do not provide
      adequate relief. Furthermore, there remains a lack of treatments that have demonstrated
      effectiveness in stopping or reversing the degenerative process. , Besides, there are
      considerable side effects associated with the use of these drugs. As a result, OA sufferers
      have turned to natural nutraceuticals to ease their pain and discomfort.

      In recent years, several novel agents have emerged as potential treatment alternatives to
      improve pain, stiffness, and function with the possibility of altering disease progression.
      These products are commonly used because they are well tolerated and considered safe. Among
      the OA patients, glucosamine and chondroitin are most commonly used and have shown to
      considerably reduce the pain associated with arthritis. From the nutraceutical point of view,
      there is a growing interest in Collagen Supplement as a solution for the treatment of OA. The
      Collagen Supplement has been studied extensively in both animals as well as human clinical
      studies. , Among animal studies, a study in the rat model of OA reported several benefits
      after treatment, suggesting its potential for the prevention of worsening of articular
      cartilage damage. In another study, porcine Collagen Supplement administration demonstrated a
      significant reduction of pain intensity. Also, a lower dose regimen showed meaningful pain
      reduction indicating its protective effect on the cartilage. Furthermore, several studies
      have evaluated the efficacy and safety of Collagen Supplement in individuals suffering from
      chronic OA. Crowley and colleagues showed that supplementation of Collagen Supplement for
      three months is more efficacious as compared to the combination of glucosamine plus
      chondroitin. In another study, 6-month administration of the Collagen Supplement
      significantly reduced pain, stiffness, and physical functioning as compared to glucosamine
      hydrochloride plus chondroitin sulfate group of participants with knee OA.

      Based on the available evidence it is clear that Collagen Supplement is effective in
      improving joint discomfort associated with OA. Moreover, collagen products are also
      recognized as safe components of pharmaceutical and foods by the US Food and Drugs
      Administration Center for Food Safety and Nutrition. Hence, considering its symptomatic
      benefits, the structural effect on the cartilage and its important role in bone structure,
      Collagen Supplement is thought to be a viable alternative for OA patients. , Therefore, the
      present study aimed to evaluate the safety and efficacy of an collagen supplementation in
      participants suffering from knee OA. Study volunteers will be supplemented with Collagen
      Supplement, an collagen product for 12 weeks and assessed as per study designated efficacy
      and safety variables. Also, the efficacy and efficacy of Collagen Supplement will be compared
      with Glucosamine HCL plus chondroitin sulfate and placebo as per the set study intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: modified Western Ontario and McMaster Score
time frame: Day0 Day 28 Day 56 Day 84
description: Effect of consumption of IP on Joint health as assessed by the change in the (mWOMAC) total score from baseline and when compared with the placebo. [From baseline to 84 days] High score defines worst outcome and low score defines better oucome.
measure: EQ-5D-5L
time frame: Day 0 and Day 84
description: Effect of consumption of IP on Joint health as assessed by the change in the EQ-5D-5L from baseline and when compared with the placebo. [From baseline to 84 days]
measure: interleukin-6 (IL - 6)
time frame: Day 0 Day 84
description: Effect of consumption of IP on Joint inflammation as assessed by the change in the inflammatory biomarker interleukin-6 (IL-6) concentration from baseline and when compared with the placebo. [From baseline to 84 days]
arm group label: Collagen Supplement
arm group type: Active Comparator
description: Three capsules post-breakfast Three capsules post-dinner
arm group label: Glucosamine chondroitin
arm group type: Other
description: Three capsules post-breakfast Three capsules post-dinner
arm group label: Placebo
arm group type: Placebo Comparator
description: Three capsules post-breakfast Three capsules post-dinner
intervention type: Other
intervention name: Collagen Supplement
description: Three capsules post-breakfast Three capsules post-dinner
arm group label: Collagen Supplement
intervention type: Other
intervention name: Glucosamine chondroitin
description: Three capsules post-breakfast Three capsules post-dinner
arm group label: Glucosamine chondroitin
intervention type: Other
intervention name: Placebo
description: Three capsules post-breakfast Three capsules post-dinner
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Shalini Srivastava, MD - Med.
role: Study Director
affiliation: Vedic Life Sciences Pvt. Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Osteoarthritis