<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/NCT04439981</url>
  </required_header>
  <id_info>
    <org_study_id>Curcuma</org_study_id>
    <nct_id>NCT04439981</nct_id>
  </id_info>
  <brief_title>Curcuma Extract Beneficial for Muscle Damage</brief_title>
  <official_title>Beneficial Effect of Curcuma Extract In Muscle Damage (Study in Soccer Athlete): Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitas Muhammadiyah Semarang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitas Muhammadiyah Semarang</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle damage and inflammation is a clinical problem caused by the unimpeachable body&#xD;
      adaptation of strenuous exercise through increasing free radicals. Antioxidants content in&#xD;
      Curcuma is hypothesized to alleviate the free radicals. This study aimed to examine the&#xD;
      effect of Curcuma extract in the form of ice cream to improve muscle damage and inflammation&#xD;
      of soccer athletes caused by strenuous exercise. This study was experimental study with&#xD;
      pre-post control group design. Male soccer athlete (n=20) were divided into treatment group&#xD;
      (n=10) and control group (n=10). The treatment group was treated by Curcuma extract ice cream&#xD;
      for 21 days. Blood samples of creatine kinase (as muscle damage marker) and IL-6 (as&#xD;
      inflammation marker) were quantified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle damage is a clinical problem caused by the adaptation process in strenuous exercise of&#xD;
      soccer athletes which free radical is the main culprit of the damage. There is a significant&#xD;
      increment of muscle damage after strength exercise using leg press. Physical exercise leads&#xD;
      to inflammation process in endothelial cells of blood vessel which can be marked by releasing&#xD;
      cytokine. Interleukin-6 (IL-6) is one of cytokine pro-inflammation and this marker is used as&#xD;
      an indicator for inflammation of micro-trauma in muscle during strenuous exercise.&#xD;
&#xD;
      Normally, free radical generation will be stabilized by endogenous antioxidant secretion such&#xD;
      as superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase; nevertheless, body&#xD;
      needs exogenous antioxidant to support endogenous antioxidant as a scavenger of free radical&#xD;
      in such condition.&#xD;
&#xD;
      Muscle damage due to the strenuous exercise should be managed to avoid the pain feeling and&#xD;
      subsequently decrease athlete performances. Some previous studies used herbs such as ginger&#xD;
      (Zingiber officinale), ginseng (Panax quinquefolium), and Curcuma to relieve the muscle&#xD;
      damage and inflammation resulting from high-intensity exercise.The Curcuma extract treatment&#xD;
      to the athlete gained lack of success; therefore, supplementation to food products might use&#xD;
      to increase acceptability. Ice cream is one of the products, which has a broad segment market&#xD;
      and every single person regardless of age is fond of it.&#xD;
&#xD;
      Curcumin is an antioxidant substance contained in Curcuma and it has better antioxidant&#xD;
      capacity compared to the other component in Curcuma such as demetoksicurcumin and&#xD;
      bisdemetoksicurcumin.Besides, curcumin has an efficient reaction with superoxide radicals as&#xD;
      well as lipid antioxidants has, and the reaction leads to superoxide catalytic degradation in&#xD;
      which curcumin represents as a superoxide dismutase. This study aimed to examine the Curcuma&#xD;
      extract effect which has been supplemented to own-made ice cream in muscle damage and&#xD;
      inflammation of soccer athletes after having strenuous exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2019</start_date>
  <completion_date type="Actual">July 29, 2019</completion_date>
  <primary_completion_date type="Actual">July 8, 2019</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>Subjects were divided by 2 groups: control group (n=10), treated by ice cream without any Curcuma extract supplementation; and treatment group (n=10), treated by ice cream supplemented by Curcuma extract.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lactic acid change</measure>
    <time_frame>21 days</time_frame>
    <description>Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin change</measure>
    <time_frame>21 days</time_frame>
    <description>Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6 change</measure>
    <time_frame>21 days</time_frame>
    <description>Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine kinase change</measure>
    <time_frame>21 days</time_frame>
    <description>Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Athletes Foot</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>treated by ice cream without any Curcuma extract supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treated by ice cream supplemented by Curcuma extract</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ice cream</intervention_name>
    <description>Curcumin extract was added into ice cream</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  14-18 year-old&#xD;
&#xD;
          -  does not have an acute and chronic&#xD;
&#xD;
          -  hemoglobin level ≥13 g/L&#xD;
&#xD;
          -  nutrition status normal (BMI &gt;18.5-25.0)&#xD;
&#xD;
          -  no coffee consumption&#xD;
&#xD;
          -  no alcohol consumption&#xD;
&#xD;
          -  no drugs consumption&#xD;
&#xD;
          -  no smoking&#xD;
&#xD;
          -  no vitamin and other supplements consumption at least two weeks before this study was&#xD;
             conducted&#xD;
&#xD;
          -  no additional exercise except the programmed exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject did not comply the procedure of the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Rosidi, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitas Muhammadiyah Semarang</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia</name>
      <address>
        <city>Semarang</city>
        <state>Provinsi</state>
        <zip>50198</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitas Muhammadiyah Semarang</investigator_affiliation>
    <investigator_full_name>Ali Rosidi, Dr</investigator_full_name>
    <investigator_title>Dean of Faculty of Nursing and Health, Universitas Muhammadiyah Semarang</investigator_title>
  </responsible_party>
  <keyword>Curcuma extract</keyword>
  <keyword>ice cream</keyword>
  <keyword>inflammation</keyword>
  <keyword>muscle damage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinea Pedis</mesh_term>
  </condition_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/NCT04439981
org study id: Curcuma
nct id: NCT04439981
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Muscle damage and inflammation is a clinical problem caused by the unimpeachable body
      adaptation of strenuous exercise through increasing free radicals. Antioxidants content in
      Curcuma is hypothesized to alleviate the free radicals. This study aimed to examine the
      effect of Curcuma extract in the form of ice cream to improve muscle damage and inflammation
      of soccer athletes caused by strenuous exercise. This study was experimental study with
      pre-post control group design. Male soccer athlete (n=20) were divided into treatment group
      (n=10) and control group (n=10). The treatment group was treated by Curcuma extract ice cream
      for 21 days. Blood samples of creatine kinase (as muscle damage marker) and IL-6 (as
      inflammation marker) were quantified.
Muscle damage is a clinical problem caused by the adaptation process in strenuous exercise of
      soccer athletes which free radical is the main culprit of the damage. There is a significant
      increment of muscle damage after strength exercise using leg press. Physical exercise leads
      to inflammation process in endothelial cells of blood vessel which can be marked by releasing
      cytokine. Interleukin-6 (IL-6) is one of cytokine pro-inflammation and this marker is used as
      an indicator for inflammation of micro-trauma in muscle during strenuous exercise.

      Normally, free radical generation will be stabilized by endogenous antioxidant secretion such
      as superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase; nevertheless, body
      needs exogenous antioxidant to support endogenous antioxidant as a scavenger of free radical
      in such condition.

      Muscle damage due to the strenuous exercise should be managed to avoid the pain feeling and
      subsequently decrease athlete performances. Some previous studies used herbs such as ginger
      (Zingiber officinale), ginseng (Panax quinquefolium), and Curcuma to relieve the muscle
      damage and inflammation resulting from high-intensity exercise.The Curcuma extract treatment
      to the athlete gained lack of success; therefore, supplementation to food products might use
      to increase acceptability. Ice cream is one of the products, which has a broad segment market
      and every single person regardless of age is fond of it.

      Curcumin is an antioxidant substance contained in Curcuma and it has better antioxidant
      capacity compared to the other component in Curcuma such as demetoksicurcumin and
      bisdemetoksicurcumin.Besides, curcumin has an efficient reaction with superoxide radicals as
      well as lipid antioxidants has, and the reaction leads to superoxide catalytic degradation in
      which curcumin represents as a superoxide dismutase. This study aimed to examine the Curcuma
      extract effect which has been supplemented to own-made ice cream in muscle damage and
      inflammation of soccer athletes after having strenuous exercise.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects were divided by 2 groups: control group (n=10), treated by ice cream without any Curcuma extract supplementation; and treatment group (n=10), treated by ice cream supplemented by Curcuma extract.
primary purpose: Treatment
masking: None (Open Label)
measure: Lactic acid change
time frame: 21 days
description: Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method
measure: Hemoglobin change
time frame: 21 days
description: Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method
measure: IL-6 change
time frame: 21 days
description: Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method
measure: Creatinine kinase change
time frame: 21 days
description: Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method
arm group label: Control Group
arm group type: Placebo Comparator
description: treated by ice cream without any Curcuma extract supplementation
arm group label: Treatment Group
arm group type: Experimental
description: treated by ice cream supplemented by Curcuma extract
intervention type: Dietary Supplement
intervention name: Ice cream
description: Curcumin extract was added into ice cream
arm group label: Control Group
arm group label: Treatment Group
criteria: 
gender: Male
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Rosidi, Doctor
role: Principal Investigator
affiliation: Universitas Muhammadiyah Semarang
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Universitas Muhammadiyah Semarang
investigator full name: Ali Rosidi, Dr
investigator title: Dean of Faculty of Nursing and Health, Universitas Muhammadiyah Semarang
mesh term: Tinea Pedis
sharing ipd: No