Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02854358
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
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

Layout table for study information
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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: seyed hamdollah mosavat, assisstant professor, Shiraz University of Medical Sciences 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:
Layout table for MeSH terms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases