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

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02854358
Collaborator
Shahid Beheshti University of Medical Sciences (Other)
60
Enrollment
2
Arms
11.1
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: mixed powder of A. digitata and M. sylvestris
  • Drug: Hypozalix spray (artificial saliva)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control

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

Drug: Hypozalix spray (artificial saliva)
Hypozalix spray (artificial saliva)
Experimental: intervention

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

Drug: mixed powder of A. digitata and M. sylvestris
Other Names:
  • Traditional Persian Medicine preparation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. changes in patients' quality of life [4 weeks]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shiraz University of Medical Sciences
    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    seyed hamdollah mosavat, assisstant professor, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02854358
    Other Study ID Numbers:
    • CT.9732
    First Posted:
    Aug 3, 2016
    Last Update Posted:
    Aug 3, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Xerostomia

    Study Results

    No Results Posted as of Aug 3, 2016