Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

ConditionXerostomia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age more than 18 years

Head and neck cancer with xerostomia

6 months post radiation

Willing to participate in this study

Disqualifiers

Sialolith or Sjogren's syndrome

Uncontrolled cancer

Using artificial saliva more than 2 weeks

Taking Pilocarpine or cevimeline more than 2 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial saliva containing cumin and ginger extract

    Other intervention

    Artificial saliva containing cumin and ginger extract in spray bottle

  • Placebo

    Other intervention

    Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Artificial saliva containing cumin and ginger extractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Amount of saliva

Spit saliva to the bottle for 5 min

Time frame
14 days

Secondary outcomes

1

Acid and base characteristic of saliva

Spit saliva to the bottle, then take 1 piece of pH strip and dip it into the saliva for 30 seconds. Compare the color of the dipped pH strip to the color chart on pH strip box. The result shows value at pH 1-14.

Time frame
14 days
2

Xerostomia questionnaires

Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).

Time frame
14 days
3

Oral Mucositis Grading Scale

Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).

Time frame
14 days
4

Adverse reaction: Skin reaction

Found or not found

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: