<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20240306061184N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-23</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes -induced peripheral neuropathy in cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes -induced peripheral neuropathy in cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75884</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants are placed in two groups of test and control by block randomization method
According to the sample size, we will have 9 blocks of 8 people and 1 block of 2 people.
In each block, half of the lottery papers will correspond to "I" or intervention and the rest will be "p" or placebo.
The medicine and placebo containers will be identical and they will be identified only based on a code that identifies which medicine and which is placebo, Blinding description: The doctor and the patient are not aware of the type of treatment (placebo or herbal product) assigned either before or after the treatment. In other words, the patient does not know which group he will be placed in and does not know whether the drug he received is the main drug under study or not. On the other hand, the doctor examining the effect of the drug should not be aware of the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Taxanes-induced peripheral neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the test group, the participants are asked to apply 1 cc of oil (vegetable) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day.  spread, a total of 6 cc daily. Intervention 2: Control group: In the control group, the participants are asked to apply 1 cc of oil (placebo) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day.  spread, a total of 6 cc daily.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information on the main outcome and secondary outcome

When:
6 months after the publication of the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
For research purposes

Where to obtain:
dr.msadeghi4431@gmail.com
Dr. Mehri Sadeghi Khansari

How to obtain:
A maximum time is one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Yosofpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Traditional and Complementary Medicine Research Center,Khazar Blvd, next to Baghban Medical Complex (Toubi), Sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3324 4893</telephone>
        <email>m.yousefpour@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad yosofpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Traditional and Complementary Medicine Research Center,Khazar Blvd, next to Baghban Medical Complex (Toubi), Sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3324 4893</telephone>
        <email>m.yousefpour@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with breast, gynecological and urology cancer in the age range of 18-80 years with complaints of peripheral neuropathy symptoms, according to the opinion of a neurologist; their neuropathy is due to chemotherapy with taxane drugs.
Are undergoing chemotherapy or have a history of chemotherapy, provided that no more than two months have passed since the completion of their chemotherapy, regardless of the number of chemotherapy courses.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having diabetes and other neuropathies such as Guillain-Barré, multiple sclerosis, and carpal tunnel syndrome
Allergy to herbal medicines
Stage 4 cancer patients
Patients who perform radiotherapy at the same time as chemotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G62.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug-induced polyneuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the test group, the participants are asked to apply 1 cc of oil (vegetable) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day.  spread, a total of 6 cc daily.</i_keyword>
      <i_keyword>Control group: In the control group, the participants are asked to apply 1 cc of oil (placebo) on the surface of the foot (from the ankle to the tip of the toes) and the surface of the hand (from the wrist to the tip of the fingers) three times a day.  spread, a total of 6 cc daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory and motor disorders and pain and symptoms of neuropathy in the lower and upper limbs. Timepoint: The beginning of the study (before the start of the intervention) and 28 days after the start of topical herbal oil consumption (the end of the intervention). Method of measurement: To quantitatively evaluate peripheral neuropathy before and after intervention(Questionnaire FACT/GOG-Ntx Version 4)Functional Assessment of Cancer Therapy for patients with neurotoxicity questionnaire - version 4 (FACT-GOG-NTX), Qualitative symptoms of peripheral neuropathy based on the scalePNQ (Patient Neurotoxicity Questionnaire), Pain before and after the intervention; Neuropathic Pain Scale (NPS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Registration of possible complications. Timepoint: While studying. Method of measurement: Side effects registration form.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-28</approval_date>
        <contact_name>Ethics Committee of Mazandaran university of Medical Sciences</contact_name>
        <contact_address>Traditional and Complementary Medicine Research Center, Khazar Blvd, Sari, Mazandaran Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
