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Effect of spaghula husk mucilage on prevention of chemotherapy-induced mucositis

Evaluation of the effect of Persian medicine based preparation from spaghula (Plantago Ovata Forsk) husk mucilage on prevention and treatment of oral mucositis in breast cancer patients receiving adriamycin

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180923041093N1
Enrollment
20
Registered
2018-12-02
Start date
2018-12-11
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Adriamycin induced oral mucositis. Oral mucositis (ulcerative) due to antineoplastic therapy

Interventions

Intervention 1: Intervention group: A mixture of (500 ml ispaghula husk and 3 drops of vinegar in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days

Sponsors

Vice chancellor for research, Kerman university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 65 Years

Inclusion criteria

Inclusion criteria: Breast cancer Candidate for adriamycin mucositis in screening course Remaining two courses of adriamycin with two weeks interval Age between 17 and 65 years Life expectancy for more than a year based on physician or team estimates Physical and mental ability to cooperate in filling in the questionnaire The desire to participate in the study

Exclusion criteria

Exclusion criteria: Use alcohol Use of drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistamine, diuretics Use of mouthwashes and artificial saliva and cigarettes Receiving Early Radiation in mouth or oropharynx The history of connective tissue diseases, such as Sjogren, rheumatoid arthritis, lupus Liver and kidney disease Major Depression Diseases that affect salivary glands such as diabetes Diseases that induce dehydration such as chronic diarrhea Diseases of the immune system Recurrent aphthous stomatitis Receiving Lithium or Levothyroxine for interference with spaghula

Design outcomes

Primary

MeasureTime frame
Degree of oral mucositis according to WHO scale. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: WHO scale for oral mucositis.;Degree of pain due to oral mucositis. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: Visual Analogue Scale.;Quality of life. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: OHIP-14 questionnaire.;Xerostomia. Timepoint: Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention). Method of measurement: LENT-SOMA scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Sadat Hasheminasab

Kerman University of Medical Sciences

hashemifa67@gmail.com+98 34 3211 0860

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 28, 2026