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Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with an artificial saliva in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers

Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with Hypozalix (artificial saliva) in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014012415860N1
Enrollment
60
Registered
2014-01-24
Start date
2014-02-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation induced xerostomia. Dry mouth, unspecified

Interventions

Intervention 1: Intervention group 1: Hypozalix 100 mL artificial saliva sprays, three times a day, every time two puffs, for 4 weeks. Intervention 2: Intervention group 2: Sachets of Malva sylvestris
Treatment - Drugs
Intervention group 1: Hypozalix 100 mL artificial saliva sprays, three times a day, every time two puffs, for 4 weeks.
Intervention group 2: Sachets of Malva sylvestris and Alcea digitata formulation, three times a day, each time one sachet into a cup of boiling water, stirred, and after cooling, drink it. For 4 weeks

Sponsors

School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: xerostomia at least grade 1 based on clinical grading CTC; adverse event 4; age between 20 to 70 years old; physically and mentally able to fill out a questionnaire; willingness to participate in the study and informed consent; at least three months after the end of radiotherapy; not drinking alcohol; drugs affecting the salivary glands like antidepressant, opioids, antihypertensive, antihistamines, diuretics, all kind of mouthwash and artificial saliva; no history of connective tissue disease like Sjogren, rheumatoid arthritis, lupus, liver disease, kidney disease, major depression, diseases involving salivary glands, diabetes, chronic diseases such as diarrhea cause dehydration; the absence ofneutropenia, immunosuppression, myelosuppression Exclusion criteria: sudden changes in systemic conditions like that a patient requires extensive chemotherapy and surgical interventions; failure/ need parenteral nutrition (TPN) or hospitalization; unwillingness to continue participation in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Xerostomia. Timepoint: Before interventin & weeks 2 and 4 after intervention. Method of measurement: VAS scale (determined by Question from patient) & Xerostomia Grade (determined by clinical examination).;Quality of life. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: EORTC questionnaire.

Secondary

MeasureTime frame
Other Symptoms. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: Question from patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazaleh Heydarirad M.D

School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh

dr.ghazalrad@sbmu.ac.ir+98 218877352

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026