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

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ClinicalTrials.gov Identifier: NCT02854358
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
seyed hamdollah mosavat, Shiraz University of Medical Sciences

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
Xerostomia Head and Neck Cancers Drug: mixed powder of A. digitata and M. sylvestris Drug: Hypozalix spray (artificial saliva) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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 Name: Traditional Persian Medicine preparation




Primary Outcome Measures :
  1. changes in patients' quality of life [ Time Frame: 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)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: seyed hamdollah mosavat, assisstant professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02854358     History of Changes
Other Study ID Numbers: CT.9732
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases