<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/NCT03262792</url>
  </required_header>
  <id_info>
    <org_study_id>VL/170105/PA/OA</org_study_id>
    <nct_id>NCT03262792</nct_id>
  </id_info>
  <brief_title>Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis</brief_title>
  <acronym>A Paniculata</acronym>
  <official_title>A Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis Over a 12-weeks Period</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>
      This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the&#xD;
      effect of Andrographis Paniculata at low dose of 300 mg/day and high dose of 600 mg/day in&#xD;
      the study population in the age range of 40-70 years and suffering from mild-moderate OA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, we will assess the efficacy parameters such as effect on various joint health&#xD;
      parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with&#xD;
      knee OA suffer from an increased impact on their activities of daily living, which leads to&#xD;
      losses in labor relations, leisure, social life, and sleeping quality, leading also to&#xD;
      important decrease in their quality of life. Thus, an important outcome to be evaluated in&#xD;
      this study is quality of life of these individuals which will be assessed by SF-36&#xD;
      self-reported questionnaire. One of the aims of this study is therefore to investigate the&#xD;
      levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after&#xD;
      the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue&#xD;
      questionnaire.&#xD;
&#xD;
      Effect of the treatment on rescue medication consumption which is directly proportional to&#xD;
      the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and&#xD;
      renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of&#xD;
      chronic use of Andrographis Paniculata on liver and kidneys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2017</start_date>
  <completion_date type="Actual">August 27, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</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>
    <intervention_model_description>Randomized, double-blind, placebo controlled, parallel groups study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC pain score</measure>
    <time_frame>84 days</time_frame>
    <description>Change in WOMAC pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC stiffness score</measure>
    <time_frame>84 days</time_frame>
    <description>Change in WOMAC stiffness score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC physical function score</measure>
    <time_frame>84 days</time_frame>
    <description>Change in WOMAC physical function score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>84 days</time_frame>
    <description>Change in SF-36's various component scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACIT score</measure>
    <time_frame>84 days</time_frame>
    <description>Change in FACIT score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue medication consumption</measure>
    <time_frame>84 days</time_frame>
    <description>Change in rescue medication consumption.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Microcrystalline cellulose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Andrographis Paniculata 150</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Andrographis Paniculata 150 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Andrographis Paniculata 300</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Andrographis Paniculata 300 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Microcrystalline cellulose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Andrographis Paniculata</intervention_name>
    <description>Andrographis Paniculata 150 mg</description>
    <arm_group_label>Andrographis Paniculata 150</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Andrographis Paniculata</intervention_name>
    <description>Andrographis Paniculata 300 mg</description>
    <arm_group_label>Andrographis Paniculata 300</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects in the age range of 40 - 70 years (both inclusive).&#xD;
&#xD;
          2. Body mass index (BMI) must be ≥ 25 and &lt; 29.9 kg/m2.&#xD;
&#xD;
          3. Radiographic evidence of grade I- II osteoarthritis of knee joint, based on the&#xD;
             Kellgren and Lawrence radiographic entry criteria with WOMAC pain score in range of&#xD;
             10-16.&#xD;
&#xD;
          4. History of primary idiopathic osteoarthritis of the knee characterized by pain of mild&#xD;
             to moderate intensity which requires intake of analgesics.&#xD;
&#xD;
          5. Self-reported difficulty in at least one of the following activities attributed to&#xD;
             knee pain: walking a distance of 400 metres, getting in and out of the car, going up&#xD;
             and down the stairs or stiffness observed in the knee if &gt; 30 minutes in the same&#xD;
             position.&#xD;
&#xD;
          6. Female subjects of child-bearing age must be willing to use the accepted methods of&#xD;
             contraception during the course of the study.&#xD;
&#xD;
          7. Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric condition,&#xD;
             alcoholism, drug abuse), medical history, physical findings, ECG findings or&#xD;
             laboratory abnormalities that in the investigator's opinion could adversely affect the&#xD;
             safety of the subject, makes it unlikely that the course of treatment or follow-up&#xD;
             would be completed or could impair the assessment of study results.&#xD;
&#xD;
          2. History of surgery or major trauma to the study joint.&#xD;
&#xD;
          3. History of arthroscopic surgery or intervention on the study joint.&#xD;
&#xD;
          4. Subjects who have received intra-articular steroids or hyaluronic acid within the last&#xD;
             three months.&#xD;
&#xD;
          5. Signs of active study joint inflammation including redness, warmth, and/or, if&#xD;
             qualifying with osteoarthritis of the knee, a large, bulging effusion of the study&#xD;
             knee joint with the loss of normal contour of the joint at the screening visit or at&#xD;
             the baseline examination after the washout period.&#xD;
&#xD;
          6. Subjects awaiting a replacement of knee or hip joint.&#xD;
&#xD;
          7. Subjects with other conditions that cause pain.&#xD;
&#xD;
          8. Subjects with deformity of the knee joint.&#xD;
&#xD;
          9. Subject who are significantly incapacitated or disabled and would be categorized as&#xD;
             ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without&#xD;
             assistive devices.&#xD;
&#xD;
         10. Subjects with other known rheumatic or inflammatory disease such as rheumatoid&#xD;
             arthritis, osteomyelitis and bone metastasis.&#xD;
&#xD;
         11. Other pathologic lesions on X-rays of knee.&#xD;
&#xD;
         12. Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human&#xD;
             immunodeficiency virus (HIV) antibody test, or VDRL.&#xD;
&#xD;
         13. History of bleeding disorders.&#xD;
&#xD;
         14. Inability to comply with the protocol requirements.&#xD;
&#xD;
         15. Participation in any other clinical trial within 3 months of registering in this&#xD;
             trial.&#xD;
&#xD;
         16. Women of child-bearing potential with a positive pregnancy test or who are lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalini Srivastava, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vedic Lifesciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nidaan Hospital, A/1, Adinath Society, Near Dosti Estate, Opposite Antop Hill Post Office, Wadala(West)</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400031</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ayush nursing Home, Gaurav vista, Gaurav Garden,BunderpakhadiRoad, Kandivali(West)</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400067</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siddhant Clinic, Shop No. 17, Lenyadri Cooperative Housing Society, Sector 19A, Nerul(East),Navi Mumbai -400706, Maharashtra</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400706</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Clinic, 213, 2nd floor, Shiv Centre, Plot no. 72, Sector-17, Vashi, Navi Mumbai.</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://hpingredients.com/products/premier-ingredients/paractin/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Andrographolide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03262792
org study id: VL/170105/PA/OA
nct id: NCT03262792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the
      effect of Andrographis Paniculata at low dose of 300 mg/day and high dose of 600 mg/day in
      the study population in the age range of 40-70 years and suffering from mild-moderate OA.
In this study, we will assess the efficacy parameters such as effect on various joint health
      parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with
      knee OA suffer from an increased impact on their activities of daily living, which leads to
      losses in labor relations, leisure, social life, and sleeping quality, leading also to
      important decrease in their quality of life. Thus, an important outcome to be evaluated in
      this study is quality of life of these individuals which will be assessed by SF-36
      self-reported questionnaire. One of the aims of this study is therefore to investigate the
      levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after
      the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue
      questionnaire.

      Effect of the treatment on rescue medication consumption which is directly proportional to
      the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and
      renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of
      chronic use of Andrographis Paniculata on liver and kidneys.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo controlled, parallel groups study.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: WOMAC pain score
time frame: 84 days
description: Change in WOMAC pain score
measure: WOMAC stiffness score
time frame: 84 days
description: Change in WOMAC stiffness score
measure: WOMAC physical function score
time frame: 84 days
description: Change in WOMAC physical function score
measure: SF-36
time frame: 84 days
description: Change in SF-36's various component scores.
measure: FACIT score
time frame: 84 days
description: Change in FACIT score
measure: Rescue medication consumption
time frame: 84 days
description: Change in rescue medication consumption.
arm group label: Placebo
arm group type: Placebo Comparator
description: Microcrystalline cellulose
arm group label: Andrographis Paniculata 150
arm group type: Active Comparator
description: Andrographis Paniculata 150 mg
arm group label: Andrographis Paniculata 300
arm group type: Active Comparator
description: Andrographis Paniculata 300 mg
intervention type: Dietary Supplement
intervention name: Placebo
description: Microcrystalline cellulose
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Andrographis Paniculata
description: Andrographis Paniculata 150 mg
arm group label: Andrographis Paniculata 150
intervention type: Dietary Supplement
intervention name: Andrographis Paniculata
description: Andrographis Paniculata 300 mg
arm group label: Andrographis Paniculata 300
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shalini Srivastava, MD
role: Study Director
affiliation: Vedic Lifesciences
facility: 
facility: 
facility: 
facility: 
country: India
url: http://hpingredients.com/products/premier-ingredients/paractin/
description: Related Info
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Andrographolide
sharing ipd: No