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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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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

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Detailed Description

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Conditions

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Xerostomia Head and Neck Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

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

Group Type ACTIVE_COMPARATOR

Hypozalix spray (artificial saliva)

Intervention Type DRUG

Hypozalix spray (artificial saliva)

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

Group Type EXPERIMENTAL

mixed powder of A. digitata and M. sylvestris

Intervention Type DRUG

Interventions

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mixed powder of A. digitata and M. sylvestris

Intervention Type DRUG

Hypozalix spray (artificial saliva)

Intervention Type DRUG

Other Intervention Names

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Traditional Persian Medicine preparation

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No