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CompletedNCT01915966Updated Feb 11, 2014

Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients

An interventional study of Cardamom, ginger and orange juice gelatin and Camomile infusion with lemon juice in Xerostomia, Salivary Gland Diseases and Mouth Diseases, sponsored by Fundacio Salut i Envelliment UAB. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2014-02-11.

Sponsored by Fundacio Salut i Envelliment UAB · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Sex
All
01

Study summary

Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.

The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.

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Conditions studied

  • Xerostomia
  • Salivary Gland Diseases
  • Mouth Diseases
03

In context

Xerostomia

254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.

This study's enrollment of 32 is below the median of 42 across 216 interventional studies indexed under Xerostomia.

Browse Xerostomia studies →

Lead sponsor

Fundacio Salut i Envelliment UAB is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years or older
  • Receiving palliative care for terminall illness at MUTUAM PADES
  • Complaining of dry mouth and should not have been treated for this problem
  • Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so

Exclusion criteria

Exclusion Criteria:

  • Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
  • Oropharinx neoplasm treated with surgery or radiotherapy.
  • Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
  • Motor dysphagia causing coordination problems in swallowing.
  • Life expectancy less than seven days (Last Days Situation).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Cardamom, ginger and orange juice gelatin

    Dietary Supplement

    Dietary Supplement: Cardamom, ginger and orange juice gelatin

  • Active comparator
    Camomile infusion with lemon juice

    Dietary Supplement

    Dietary Supplement: Camomile infusion with lemon juice

Interventions

  • Dietary supplementCardamom, ginger and orange juice gelatin

    Patients will receive the recipe of the gelatin, with detailed instructions to prepare it at home, and the necessary ingredients for the gelatin. If necessary, they will be helped in the preparation of an initial batch that should last for one week of treatment. Patients will be instructed to consume the gelatin candy as necessary to alleviate the dry mouth sensation

  • Dietary supplementCamomile infusion with lemon juice

    Patients will receive instructions to prepare the infusion at home, and the necessary ingredients. Patients will be instructed to ingest the infusion as necessary to alleviate the dry mouth sensation.

06

What researchers measure

Primary outcomes

  1. Scale of self-perceived mouth dryness (0=not at all, 10=very dry)

    Time frame: At end of treatment (1 week )

Secondary outcomes

  1. Objective signs of xerostomia

    Investigator will assess the presence of xerostomia signs through the assessment of 1) appearance and degree of dryness of tongue, buccal mucosa and lips, and 2)difficulties in speech derived from dry-mouth sensation in the patient.

    Time frame: At end of treatment (1 week )

  2. Scale of subjective assessment of salival disfunction (Pai 2001).

    Time frame: At end of treatment (1 week )

  3. Treatment acceptability

    Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.

    Time frame: At end of treatment (1 week )

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Study locations

1 site
  • MUTUAM
    Barcelona, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01915966
Lead sponsor
Fundacio Salut i Envelliment UAB
Collaborators
Mutuam
Responsible party
Teresa Peris (Palliativa Care Nurse, Mutuam) — Principal investigator
First posted
Aug 5, 2013
Start date
Apr 2013
Primary completion
Jan 2014
Last update
Feb 11, 2014

Study contacts

Teresa Peris, RN
principal investigator · Mutuam

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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