xml: <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/NCT05971186</url>
    </required_header>
    <id_info>
      <org_study_id>703/UN6.KEP/EC/2022</org_study_id>
      <nct_id>NCT05971186</nct_id>
    </id_info>
    <brief_title>Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea</brief_title>
    <official_title>Single-Blinded Randomized Controlled Trial: Comparative Efficacy of Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Padjadjaran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitas Padjadjaran</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Dysmenorrhea, the painful condition experienced by women during menstruation, affects a&#xD;
        significant proportion of women worldwide and often leads to decreased productivity. Various&#xD;
        pharmacological and non-pharmacological treatments are available for pain relief, but&#xD;
        information on their effectiveness, particularly regarding green coconut water, dark&#xD;
        chocolate, and Ibuprofen, remains limited. This study aimed to compare the effectiveness of&#xD;
        green coconut water, dark chocolate bars, and Ibuprofen in reducing the intensity of primary&#xD;
        dysmenorrhea. A randomized controlled trial with a quantitative design was conducted,&#xD;
        involving 45 participants randomly assigned to receive either 330 ml of green coconut water,&#xD;
        35 grams of 70% dark chocolate, or 400 mg Ibuprofen. Pain intensity was measured before and&#xD;
        after treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dysmenorrhea, commonly known as period pain, is a prevalent condition that affects a large&#xD;
        number of women during menstruation, causing discomfort and often leading to reduced&#xD;
        productivity. While several treatments are available to alleviate the pain, there is limited&#xD;
        information on the comparative effectiveness of different interventions, including green&#xD;
        coconut water, dark chocolate, and Ibuprofen.&#xD;
  &#xD;
        This research aimed to conduct a randomized controlled trial to compare the effectiveness of&#xD;
        green coconut water, dark chocolate bars, and Ibuprofen in managing primary dysmenorrhea. A&#xD;
        total of 45 participants were enrolled in the study and randomly assigned to one of three&#xD;
        intervention groups: green coconut water, dark chocolate bars, or Ibuprofen.&#xD;
  &#xD;
        The green coconut water group received 330 ml of pure green coconut water, which is known for&#xD;
        its potential health benefits and natural electrolyte content. The dark chocolate group&#xD;
        received 35 grams of 70% dark chocolate, as some studies have suggested its potential role in&#xD;
        pain relief due to the presence of bioactive compounds. The Ibuprofen group received 400 mg&#xD;
        of the common over-the-counter nonsteroidal anti-inflammatory drug (NSAID) known for its&#xD;
        analgesic properties.&#xD;
  &#xD;
        To assess the effectiveness of each intervention, pain intensity was measured before and&#xD;
        after treatment using validated pain scales. The Kruskal-Wallis test, a non-parametric&#xD;
        statistical method, was used to analyze the data and compare the effectiveness of the three&#xD;
        interventions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 30, 2022</start_date>
    <completion_date type="Actual">August 15, 2022</completion_date>
    <primary_completion_date type="Actual">August 15, 2022</primary_completion_date>
    <phase>Phase 2</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>The sample comprised 45 female students from Saleha Midwifery Academy who met the inclusion criteria and voluntarily consented after a detailed explanation. Sample size was determined using the Federer formula, yielding a minimum of 9 participants per group. However, 15 samples were included in each of the three treatment groups, resulting in a total of 45 subjects due to the three interventions.&#xD;
  Simple random sampling via Microsoft Excel's random name selection feature was used to select participants from the accessible population. Random allocation to treatment or control groups was done without bias, using a blocking system and designated application.&#xD;
  The samples were divided into three groups: Group 1 received young coconut water, Group 2 received 70% dark chocolate bar, and Group 3 received 1 tablet of Ibuprofen, an NSAID. Allocation to each group was randomized using a designated application and a block system.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>This quantitative study uses a Single-blind Randomized Controlled Trial (RCT) design. Key roles, including researcher, subjects, data analyst, collector, and assistant, ensure blinding to individual treatments. Blinding subjects is infeasible due to distinct interventions (young coconut water, dark chocolate, Ibuprofen). The research hypothesis remains undisclosed in the Informed Consent. Subjects won't discuss interventions with involved parties. Implementing this robust design aims to generate unbiased results contributing to scientific knowledge.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>The Pain intensity measured 2 times. Before the intervention and two hours after the intervention</time_frame>
      <description>Pain intensity was measured using a Numeric Rating Scale (NRS) observation sheet, allowing respondents to rate their pain intensity on a scale from 0 to 10</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Dysmenorrhea Primary</condition>
    <condition>Menstrual Pain</condition>
    <condition>Ibuprofen</condition>
    <arm_group>
      <arm_group_label>Ibuprofen</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Fifteen participants were randomly selected to form the third intervention group. Each subject in this arm received a single tablet of Ibuprofen, with a dosage of 400 mg. Similar to the other arms, they were given a 15-minute window to take the Ibuprofen tablet.&#xD;
  Prior to administering the Ibuprofen, the pain intensity of the participants was measured using the standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was measured again two hours after the consumption of the Ibuprofen tablet, using the same Numeric Rating Scale (NRS).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Young Coconut Water</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Fifteen participants were randomly selected to join the intervention group. Each subject in this arm received a single dose of 330 ml of young coconut water. To ensure uniformity, they were given a 15-minute window to consume the entire 330 ml of the young coconut water intervention.&#xD;
  Before administering the young coconut water, the pain intensity of the participants was measured using a standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was reevaluated two hours after the consumption of the young coconut water, using the same Numeric Rating Scale (NRS).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dark Chocolate Bar</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Fifteen participants were also randomly chosen for the second intervention group. In this arm, each subject received a single 70% dark chocolate bar weighing 35 grams. Similar to Arm 1, they were given a 15-minute timeframe to consume the entire dark chocolate bar intervention.&#xD;
  Prior to giving the dark chocolate bar, the pain intensity of the participants was measured using the Numeric Rating Scale (NRS). Subsequently, the pain intensity was reassessed two hours after the consumption of the dark chocolate bar, using the same Numeric Rating Scale (NRS).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ibuprofen 400 mg</intervention_name>
      <description>Dosage Form: Tablet Dosage: 1 tablet of Ibuprofen (400 mg) Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption</description>
      <arm_group_label>Ibuprofen</arm_group_label>
      <other_name>Ibuprofen 400 mg - Novapharin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Young Coconut Water</intervention_name>
      <description>Dosage Form: Liquid (coconut water) Dosage: 330 ml (milliliters) of young coconut water Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.</description>
      <arm_group_label>Young Coconut Water</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dark Chocolate Bar</intervention_name>
      <description>Dosage Form: Solid (dark chocolate bar) Dosage: 35 grams of 70% dark chocolate Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.</description>
      <arm_group_label>Dark Chocolate Bar</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged between 17 and 24 years&#xD;
  &#xD;
            -  Diagnosed with primary dysmenorrhea based on specific characteristics and assessment&#xD;
  &#xD;
            -  Willing to refrain from using any pharmacological or non-pharmacological therapies&#xD;
               other than the interventions provided by the researcher&#xD;
  &#xD;
            -  willing to participate as respondents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergies to dark chocolate or young coconut water or contraindications to Ibuprofen&#xD;
               consumption&#xD;
  &#xD;
            -  Diagnosed with specific gynecological conditions.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>In this study, eligibility criteria based on gender require the participation of individuals identifying as female. The research focuses on assessing the effectiveness of interventions for managing primary dysmenorrhea, a condition specific to individuals with female reproductive systems. Therefore, only individuals who identify as female and experience primary dysmenorrhea are eligible to participate in this study. All other gender identities are not included in the eligibility criteria, as the study aims to investigate the impact of the interventions specifically on female participants with primary dysmenorrhea.</gender_description>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kaifar Nuha, STrKeb,M.Keb</last_name>
      <role>Study Director</role>
      <affiliation>Universitas Padjadjaran</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Saleha Academy of Midwifery</name>
        <address>
          <city>Banda Aceh</city>
          <state>Aceh</state>
          <zip>23239</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dark Chocolate</keyword>
    <keyword>Young Coconut Water</keyword>
    <keyword>Ibuprofen</keyword>
    <keyword>Pain Intensity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dysmenorrhea</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ibuprofen</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971186
  org study id: 703/UN6.KEP/EC/2022
  nct id: NCT05971186
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dysmenorrhea, the painful condition experienced by women during menstruation, affects a
        significant proportion of women worldwide and often leads to decreased productivity. Various
        pharmacological and non-pharmacological treatments are available for pain relief, but
        information on their effectiveness, particularly regarding green coconut water, dark
        chocolate, and Ibuprofen, remains limited. This study aimed to compare the effectiveness of
        green coconut water, dark chocolate bars, and Ibuprofen in reducing the intensity of primary
        dysmenorrhea. A randomized controlled trial with a quantitative design was conducted,
        involving 45 participants randomly assigned to receive either 330 ml of green coconut water,
        35 grams of 70% dark chocolate, or 400 mg Ibuprofen. Pain intensity was measured before and
        after treatment.
  Dysmenorrhea, commonly known as period pain, is a prevalent condition that affects a large
        number of women during menstruation, causing discomfort and often leading to reduced
        productivity. While several treatments are available to alleviate the pain, there is limited
        information on the comparative effectiveness of different interventions, including green
        coconut water, dark chocolate, and Ibuprofen.
  
        This research aimed to conduct a randomized controlled trial to compare the effectiveness of
        green coconut water, dark chocolate bars, and Ibuprofen in managing primary dysmenorrhea. A
        total of 45 participants were enrolled in the study and randomly assigned to one of three
        intervention groups: green coconut water, dark chocolate bars, or Ibuprofen.
  
        The green coconut water group received 330 ml of pure green coconut water, which is known for
        its potential health benefits and natural electrolyte content. The dark chocolate group
        received 35 grams of 70% dark chocolate, as some studies have suggested its potential role in
        pain relief due to the presence of bioactive compounds. The Ibuprofen group received 400 mg
        of the common over-the-counter nonsteroidal anti-inflammatory drug (NSAID) known for its
        analgesic properties.
  
        To assess the effectiveness of each intervention, pain intensity was measured before and
        after treatment using validated pain scales. The Kruskal-Wallis test, a non-parametric
        statistical method, was used to analyze the data and compare the effectiveness of the three
        interventions.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The sample comprised 45 female students from Saleha Midwifery Academy who met the inclusion criteria and voluntarily consented after a detailed explanation. Sample size was determined using the Federer formula, yielding a minimum of 9 participants per group. However, 15 samples were included in each of the three treatment groups, resulting in a total of 45 subjects due to the three interventions.
  Simple random sampling via Microsoft Excel's random name selection feature was used to select participants from the accessible population. Random allocation to treatment or control groups was done without bias, using a blocking system and designated application.
  The samples were divided into three groups: Group 1 received young coconut water, Group 2 received 70% dark chocolate bar, and Group 3 received 1 tablet of Ibuprofen, an NSAID. Allocation to each group was randomized using a designated application and a block system.
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  masking description: This quantitative study uses a Single-blind Randomized Controlled Trial (RCT) design. Key roles, including researcher, subjects, data analyst, collector, and assistant, ensure blinding to individual treatments. Blinding subjects is infeasible due to distinct interventions (young coconut water, dark chocolate, Ibuprofen). The research hypothesis remains undisclosed in the Informed Consent. Subjects won't discuss interventions with involved parties. Implementing this robust design aims to generate unbiased results contributing to scientific knowledge.
  measure: Pain Intensity
  time frame: The Pain intensity measured 2 times. Before the intervention and two hours after the intervention
  description: Pain intensity was measured using a Numeric Rating Scale (NRS) observation sheet, allowing respondents to rate their pain intensity on a scale from 0 to 10
  arm group label: Ibuprofen
  arm group type: Active Comparator
  description: Fifteen participants were randomly selected to form the third intervention group. Each subject in this arm received a single tablet of Ibuprofen, with a dosage of 400 mg. Similar to the other arms, they were given a 15-minute window to take the Ibuprofen tablet.
  Prior to administering the Ibuprofen, the pain intensity of the participants was measured using the standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was measured again two hours after the consumption of the Ibuprofen tablet, using the same Numeric Rating Scale (NRS).
  arm group label: Young Coconut Water
  arm group type: Active Comparator
  description: Fifteen participants were randomly selected to join the intervention group. Each subject in this arm received a single dose of 330 ml of young coconut water. To ensure uniformity, they were given a 15-minute window to consume the entire 330 ml of the young coconut water intervention.
  Before administering the young coconut water, the pain intensity of the participants was measured using a standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was reevaluated two hours after the consumption of the young coconut water, using the same Numeric Rating Scale (NRS).
  arm group label: Dark Chocolate Bar
  arm group type: Active Comparator
  description: Fifteen participants were also randomly chosen for the second intervention group. In this arm, each subject received a single 70% dark chocolate bar weighing 35 grams. Similar to Arm 1, they were given a 15-minute timeframe to consume the entire dark chocolate bar intervention.
  Prior to giving the dark chocolate bar, the pain intensity of the participants was measured using the Numeric Rating Scale (NRS). Subsequently, the pain intensity was reassessed two hours after the consumption of the dark chocolate bar, using the same Numeric Rating Scale (NRS).
  intervention type: Drug
  intervention name: Ibuprofen 400 mg
  description: Dosage Form: Tablet Dosage: 1 tablet of Ibuprofen (400 mg) Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption
  arm group label: Ibuprofen
  other name: Ibuprofen 400 mg - Novapharin
  intervention type: Other
  intervention name: Young Coconut Water
  description: Dosage Form: Liquid (coconut water) Dosage: 330 ml (milliliters) of young coconut water Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.
  arm group label: Young Coconut Water
  intervention type: Other
  intervention name: Dark Chocolate Bar
  description: Dosage Form: Solid (dark chocolate bar) Dosage: 35 grams of 70% dark chocolate Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.
  arm group label: Dark Chocolate Bar
  criteria: 
  gender: Female
  gender based: Yes
  gender description: In this study, eligibility criteria based on gender require the participation of individuals identifying as female. The research focuses on assessing the effectiveness of interventions for managing primary dysmenorrhea, a condition specific to individuals with female reproductive systems. Therefore, only individuals who identify as female and experience primary dysmenorrhea are eligible to participate in this study. All other gender identities are not included in the eligibility criteria, as the study aims to investigate the impact of the interventions specifically on female participants with primary dysmenorrhea.
  minimum age: 17 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kaifar Nuha, STrKeb,M.Keb
  role: Study Director
  affiliation: Universitas Padjadjaran
  facility: 
  country: Indonesia
  responsible party type: Sponsor
  mesh term: Dysmenorrhea
  mesh term: Ibuprofen