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Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis in head and neck cancer patients

Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis in head and neck cancer patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014120520208N1
Enrollment
44
Registered
2015-09-29
Start date
2014-12-22
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

Mucositis. Oral mucositis (ulcerative)

Interventions

Intervention 1: Intervention group 1: 4 gram Sachets of Malva sylvestris & Alcea digitata compound (2 grams of each Herb)
For 7 weeks
3 times daily after meals. Intervention 2: Control Group: 4 gram Sachets of Avecil
3 times a day, after meals.
Treatment - Drugs
Placebo
Intervention group 1: 4 gram Sachets of Malva sylvestris & Alcea digitata compound (2 grams of each Herb)
3 times daily after meals
Control Group: 4 gram Sachets of Avecil
3 times a day, after meals

Sponsors

Vice Chancellor for research of Shahed University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with 17-65 years old in both sexes; candidate for radiotherapy for head & neck cancers; life expectancy over 1 year; Good performance status in ECOG questionnaire; At least 4 areas in RT fields Early Exclusion criteria: Patients with organic & suppressive disorders; Use of drugs effective on salivary glands, cigar or alcohol; History of Rt in last 6 months; Grade 3-4 Mucositis, candidiasis, oral herpes; Failure to treat, Hospitalization or need to TPN; Lack of interest in work

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mucositis. Timepoint: At the baseline, Weeks 1,2,3,4,5,6,7. Method of measurement: Examination of Oral Cavity.;Pain. Timepoint: At the baseline, Weeks 1,2,3,4,5,6,7. Method of measurement: Visual Analogue Scale.;Quality of Life. Timepoint: Weeks 1,2,3,4,5,6,7. Method of measurement: EORTC questionnaire.

Secondary

MeasureTime frame
Side Effects. Timepoint: Weeks 1,2,3,4,5,6,7. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasser Rezaeipour

Shahed University of Medical Sciences

drrezaeipour92@gmail.com+98 21 2288 2521

Outcome results

None listed

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