Clinical trial · Interventional
Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL). HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypozalix spray (artificial saliva) | Drug | — | UNRESOLVED |
| mixed powder of A. digitata and M. sylvestris | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks.
- interventionNames
- Drug: Hypozalix spray (artificial saliva)
- type
- EXPERIMENTAL
- label
- intervention
- description
- Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks
- interventionNames
- Drug: mixed powder of A. digitata and M. sylvestris
Primary outcomes (1)
- measure
- changes in patients' quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22). Exclusion Criteria: * history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris
References
Publications (1)
- DERIVEDHeydarirad G, Rezaeizadeh H, Choopani R, Mosavat SH, Ameri A. Efficacy of a traditional Persian medicine preparation for radiation-induced xerostomia: a randomized, open-label, active-controlled trial. J Integr Med. 2017 May;15(3):201-208. doi: 10.1016/S2095-4964(17)60333-9. PMID 28494850