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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.
There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial saliva containing cumin and ginger extract | Experimental | Artificial saliva containing cumin and ginger extract in spray bottle |
|
| Placebo | Placebo Comparator | Placebo containing composition close to the test group without cumin and ginger extract in spray bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial saliva containing cumin and ginger extract | Other | Artificial saliva containing cumin and ginger extract in spray bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of saliva | Spit saliva to the bottle for 5 min | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Xerostomia questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pornanong Aramwit, Professor | Contact | +66899217255 | aramwit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pornanong Aramwit, Professor | Chulalongkorn University | Principal Investigator |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Placebo | Other | Placebo containing composition close to the test group without cumin and ginger extract in spray bottle |
|
Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)). |
| 14 days |
| Oral Mucositis Grading Scale | Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)). | 14 days |
| Adverse reaction: Skin reaction | Found or not found | 14 days |
| Adverse reaction: Respiratory reaction | Found or not found | 14 days |
| Adverse reaction: Gastrointestinal trat reaction | Found or not found | 14 days |
| Quality of life of the patient | Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)). | 14 days |
| Satisfaction of the patient | Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)). | 14 days |