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Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

Primary Purpose

Xerostomia, Head and Neck Cancers

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
mixed powder of A. digitata and M. sylvestris
Hypozalix spray (artificial saliva)
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22).

Exclusion Criteria:

  • history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control

    intervention

    Arm Description

    In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks.

    Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks

    Outcomes

    Primary Outcome Measures

    changes in patients' quality of life
    changes in patients' quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire|(EORTC QLQ-H&N 35)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2016
    Last Updated
    August 2, 2016
    Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02854358
    Brief Title
    Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    5. Study Description

    Brief Summary
    Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL). HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Xerostomia, Head and Neck Cancers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks.
    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks
    Intervention Type
    Drug
    Intervention Name(s)
    mixed powder of A. digitata and M. sylvestris
    Other Intervention Name(s)
    Traditional Persian Medicine preparation
    Intervention Type
    Drug
    Intervention Name(s)
    Hypozalix spray (artificial saliva)
    Intervention Description
    Hypozalix spray (artificial saliva)
    Primary Outcome Measure Information:
    Title
    changes in patients' quality of life
    Description
    changes in patients' quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire|(EORTC QLQ-H&N 35)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22). Exclusion Criteria: history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28494850
    Citation
    Heydarirad G, Rezaeizadeh H, Choopani R, Mosavat SH, Ameri A. Efficacy of a traditional Persian medicine preparation for radiation-induced xerostomia: a randomized, open-label, active-controlled trial. J Integr Med. 2017 May;15(3):201-208. doi: 10.1016/S2095-4964(17)60333-9.
    Results Reference
    derived

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    Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

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