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NCT06114797
Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly
NA trial testing Chamomile in Xerostomia Due to Hyposecretion of Salivary Gland in 88 participants. Completed in 1 September 2023.
20 August 2023
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 1 July 2023 |
| Primary completion | 20 August 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Chamomile — full drug profile →
- Saline mouthwash
Conditions studied
- Xerostomia Due to Hyposecretion of Salivary Gland — all drugs for Xerostomia Due to Hyposecretion of Salivary Gland →
Sponsor
Ain Shams University
Who can join
66 and older, any sex, with Xerostomia Due to Hyposecretion of Salivary Gland. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background and Objectives: Chronic hemodialysis causes changes in blood chemistry as well as dry mouth, due to removal of excess fluids. Dry mouth is due to hyposalivation or change in saliva composition. Many herbal medicines have been used as treatment options. Since the chamomile was suggested as a potent oral moisturizer by previous studies that have been done in this field. Therefore, the investigators decided to assess the effect of chamomile oral rinse on the SXI score, salivary nitric oxide level, salivary flow rate, OHIP-14, serum creatinine and blood urea levels in elderly patients on chronic hemodialysis. Material and Methods: It is an interventional randomized controlled clinical trial with a biochemical assessment. A chamomile, and placebo mouthwashes were provided to eighty-eight elderly participants with end-stage renal disease suffering from xerostomia. Patients were divided into 2 equal groups who used either the chamomile or placebo mouthwash for one month. The SXI score and salivary flow rate were evaluated for both groups at different intervals (baseline, 1 week, and 1 month). While salivary NO levels, OHIP-14, serum creatinine and blood urea levels evaluated at baseline and after one month only.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06114797 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 27 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06114797.
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