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Assessment of Modiff effect on xerostomia

Randomized double blind clinical trial for assessing the effect of Modiff versus placebo on radiation induced xerostomia of head and neck patients.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092629998N1
Enrollment
30
Registered
2016-10-30
Start date
2016-10-22
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

xerostomia. Disturbances of salivary secretion

Interventions

Intervention 1: intervention group:Modiff drug.the combination of Althea and Plantago psyllium and mallow.5 gram saschet. every 8 houres each saschet dissolve in 1 glass of water .drinl daily for 3mou
Treatment - Drugs
intervention group:Modiff drug.the combination of Althea and Plantago psyllium and mallow.5 gram saschet. every 8 houres each saschet dissolve in 1 glass of water .drinl daily for 3mounths
placebo group:each sachet contains 5 gram wheat flour plus food colouring produced by Magnolia company. every 8 houres each saschet dissolve in 1 glass of water .drinl daily for 3mounths

Sponsors

Salamat negar Hekmat pazhoohan corporation ofof Medical Science Traditional Medical School of Tehran
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criterias:xerostomia at least grade 2 based on Avraham Eisbruch trial's grading(grade1:no malfunction, grade 2:need to exess fluid to swallow, grade 3: changes in nutririon ,sleep,speech and other activities); taking more than 40gray radition to head and neck to be more than three major salivary glands in the radition field;age of 18 years and older; at least 3 mounths later than the end of the radation. Exclusion criteria:alcohol and other drugs consumption that affect salivary glands like anti depressant;history of connective tissue and collagen vascular diseases like sjogren, rheumatoid arthritis, lupus;systemic or local reccurents;need to prenteralnutrition hospitalsation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Saliva amount. Timepoint: 3times in 3 mountes intervals. Method of measurement: collecting saliva in 5 mintusein the 1 scaled test tube.;Quality of life. Timepoint: 3times in 3 mountes intervals. Method of measurement: questionare.

Secondary

MeasureTime frame
Constipation. Timepoint: 3times in 3 mountes intervals. Method of measurement: questionare.;Skin dryness. Timepoint: 3times in 3 mountes intervals. Method of measurement: questionare.;Quality of sleep. Timepoint: 3times in 3 mountes intervals. Method of measurement: questionare.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeedeh Archang

Cancer Institue of Imam Khomeyni Hospital Complex

saeedeh.archang@yahoo.com+98 21 6119 2585

Outcome results

None listed

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