Effect of Nigella Sativa on Selected Outcomes Among Patients With Chronic Rhinosinusitis: Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Severity of physiological symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22)
研究概览
简要总结
the study is intended to test the effect of Nigella sativa nasal oil drops on selected outcomes among patients with chronic rhinosinusitis using prospective clinical trial design. To achieve the aim of the current trial the following research hypotheses are postulated: H1. The total severity of symptoms mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total severity of symptoms mean scores of a control group.
H2. The total sleep quality mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total sleep quality mean scores of a control group.
H3. The total patient satisfaction mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total patient satisfaction mean scores of a control group.
详细描述
The clinical trial will be conducted to examine the effect of administering a daily dose of 100 mg Nigella sativa nasal oil drops for four weeks on selected outcomes which include severity of symptoms, sleep quality and patient satisfaction among patients with chronic rhinosinusitis. The trial will be conducted on 102 adult patients with chronic rhinosinusitis who will be randomly assigned to either a study group (51 participant) who will receive Nigella sativa beside the standard treatment or a control group (51 participant) who will receive the standard treatment only. The current trial will be conducted in the Ear, Nose and Throat (ENT) outpatient clinic at Kasr Al Ainy University Hospital, Cairo, Egypt. Required data will be collected by using the following four tools: (a) Demographic and Medical Data Form (DMDF), (b) Sino-Nasal Outcome Test 22 (SNOT-22), (c) Sleep Quality Scale (SQS) and (d) Treatment Satisfaction Questionnaire for Medication (TSQM). The researcher prepared a flyer that will be handed in for the study group to explain how the oil will be utilized by the participants. The formal initial approval was obtained from Research Ethics Committee at Faculty of Nursing, Cairo University and an official permission was also obtained from the hospital administrators for conducting the trial. The researcher collaborated with Emeritus Professor in Pharmacognosy from the College of Pharmacy for the preparation of N. sativa nasal oil drops from Nigella sativa and Sesame seeds. Thereafter, data collection will be carried out from both groups using the following five steps as follows: recruitment and randomization; interviewing; initial assessment; intervention; follow-up and monitoring.
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
- Single (Participant)
盲法说明
participants in both groups will be blinded to which treatment arms they will be assigned to till the end of the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients from 18 to 60 years old,
- •able to communicate,
- •having a confirmed diagnosis of CRS by signs and symptoms and meeting the criteria of having twelve consecutive weeks or longer of two or more of the following signs and symptoms will be recruited for the current trial: (a) mucopurulent drainage, (b) nasal obstruction/congestion, (c) facial pain-pressure-fullness and (d) decreased sense of smell; and one or more of the following signs and symptoms: (a) purulent mucus or edema in middle meatus or anterior ethmoid region or (b) radiographic imaging showing sinus inflammation.
排除标准
- •Pregnancy,
- •lactating mothers,
- •immunodeficiency,
- •scheduled for surgical management for nasal polyposis,
- •fever more than 37.8 ﹾC,
- •patients with coagulation disorders or using anticoagulants,
- •patients taking non-potassium sparing diuretics,
- •patients allergic to N. sativa (patients reactive to sensitivity test)
- •patients using any type of natural products as a complementary therapy at the time of the trial.
研究组 & 干预措施
Study group
Nigella sativa nasal oil drops
干预措施: Nigella sativa nasal oil drops (Other)
Study group
Nigella sativa nasal oil drops
干预措施: standard treatment (Drug)
Control group
standard treatment
干预措施: standard treatment (Drug)
结局指标
主要结局
Severity of physiological symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22)
时间窗: from two to four weeks
SNOT-22 consists of 22 items that measure four domains as follows: (a) nasal symptoms domain that contains eight items, (b) otologic symptoms domain which includes four items, (c) sleep symptoms domain which includes seven items and (d) emotional symptoms domain that contains three items. SNOT-22 is scored using a Likert scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem" and 5="Problem as bad as it can be". The overall scores of the SNOT-22 is ranged from 0 to 110 with higher scores suggesting symptom severity.
Sleep quality as measured by Sleep Quality Scale (SQS)
时间窗: from two to four weeks
Sleep Quality Scale (SQS) consists of 28 items, which evaluate six domains of sleep quality as follows: (a) daytime dysfunction/symptoms which contain twelve items, (b) restoration after sleep which include four items, (c) difficulty falling asleep that contain four items, (d) difficulty getting up that include three items, (e) difficulty in maintaining asleep which contain two items and (f) satisfaction with sleep which include three items. Sleep Quality Scale is scored through a four-point, Likert-type scale; (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) are reversely scored. Total scores are ranged from 0 to 84, with higher scores denoting more acute sleep problems.
次要结局
- severity of sleep and emotional symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22) (sleep and emotional symptoms domains)(from two to eight weeks)
- patient satisfaction as measured by Treatment Satisfaction Questionnaire with Medications (TSQM)(from two to eight weeks)
研究者
Reham Samir Fatehallah
Assistant Lecturer at Medical-Surgical Nursing, Faculty of Nursing
Cairo University