Chamomile Effect on Xerostomia Associated With End-stage Renal Disease in Elderly: A Randomized Clinical Trial With a Biochemical Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- The Summated Xerostomia Inventory (SXI)
研究概览
简要总结
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.
详细描述
A double-blind (interventional) cross-sectional clinical trial was performed on 88 participants in the hemodialysis center at Benha university. The inclusion criteria were both genders above 30 years of age with ESRD and complaints of dry mouth sensation. The exclusion criteria were significant salivary gland damage (for example, due to anticancer medication), radiotherapy or chemotherapy history, and allergies).
Bottles containing chamomile mouthwash or the placebo (A or B) were tagged by a reliable person outside the research group and placed inside an opaque envelope along with the questionnaires. Each patient received two envelopes containing a bottle (A & B) and a questionnaire. The results were analyzed exclusively by a statistics consultant at the end of the research. The patients were asked to express their sensation of dry mouth using subjective dry mouth score.
The Summated Xerostomia Inventory (SXI) (Thomson et al., 2011; Frigaard et al., 2023):
ESRD patients who met the eligibility criteria were asked about their subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements all recorded at 3 different intervals (at baseline- after 2 weeks- after 1 month).
Salivary flow rate: Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection was timed, so that flow rate (mL/min) could be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants in both groups will not recognize the type of applied treatment whether it is saline mouthwash or chamomile mouthwash.
Outcome assessor will not know whether the patients they are assessing are from the control or the intervention group.
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, aged above 65 years.
- •All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
- •Patients on hemodialysis ≥ 3 months (Bots et al., 2005).
- •All patients must have complaint of xerostomia.
- •Patients must be able to make reliable decision or communications.
排除标准
- •- Smoking, Alcohol.
- •Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- •Patients with any autoimmune disease.
- •Vulnerable groups such as prisoners, mentally and physically handicapped individuals.
结局指标
主要结局
The Summated Xerostomia Inventory (SXI)
时间窗: one month
subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements. Each statement has three possible replies: never, occasionally, or often, with scoring 1, 2, and 3, respectively. The SXI has a score range from (5 to 15), where a maximum score indicates severe problems related to dry mouth
次要结局
- Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method(one month)
- Increase in unstimulated Salivary Flow Rate (ml/min)(one month)
- The Oral Health Impact Profile (OHIP-14) questionnaire(one month)
- Serum creatinine and blood urea levels(one month)
研究者
Asmaa Aboubakr
Lecturer Assistant
Ain Shams University