A prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in blood glucose levels
研究概览
简要总结
This study is a prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions.
Healthy adult human subjects of 18 to 55 years (both inclusive) were recruited. Body-mass index of ³ 18.5 kg/m2 and £ 30.0 kg/m2, with body weight not less than 50 kg who were judged healthy on the basis of a pre-study physical examination and clinical laboratory tests were included in the study.
Changes in blood glucose levels from baseline (0.00) to 15, 30 and 60 minutes and salivary pH from baseline (0.00) to 15, 30, 60, 120 and 180 minutes post application of toothpaste was evaluated using repeated measures ANOVA.Subject’s acceptance on dental toothpaste by assessing palatability questionnaire was evaluated using Wilcoxon non-parametric test.
Based on graphical representation, strontium Chloride 10 % Medicated Dental Cream does not increase blood glucose levels at various time points i.e.; 15, 30 and 60 minutes. Strontium Chloride 10 % Medicated Dental Cream dose not caused significant change in salivary pH; it maintained within the range of 6.96 to 7.12. Normal pH range of saliva is 6.7-7.3.
62 % subjects reported ‘good’ & 28 % subject reported ‘very good’ on taste.
There were no reports of death, serious or unexpected adverse events. A total of 02 adverse events were reported in two (02) subjects during entire conduct of the study. No adverse events were reported during study period. During post study safety assessment, two (02) adverse events were reported in 02 participants. In that, Increased glucose random was reported in two participants (i.e. Participant IDs: 10 & 33) which was mild in severity and possibly related to the dental cream application. All the adverse events were considered as resolved with no sequelae (except Participant ID: 10 was considered as lost to follow-up).
Based on results, it has been concluded that the Strontium Chloride 10% w/w Medicated Dental Cream does not increase blood glucose levels at various time points i.e.; 15, 30 and 60 minutes in healthy, adult, human male subjects, under fasting conditions.
Strontium Chloride 10% w/w Medicated Dental Cream does not cause significant change in salivary pH; it maintained within the range of 6.96 to 7.12. Almost 62 % subjects reported ‘good’ & 28 % subjects reported ‘very good’ on taste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy human male subjects within the age range of 18 to 55 years (inclusive of both)
- •Body-mass index of more than or equal to 18.5 kg/m2 and less than or equal to 30.0 kg/m2, with body weight not less than 50 kg.
- •Willingness to provide written informed consent to participate in the study.
- •Absence of significant disease, laboratory examinations within acceptable range, medical history and with normal physical examination during the screening.
- •Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
排除标准
- •Personal / family history or presence of allergy or hypersensitivity to Strontium Chloride or to any of the components of the formulations.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Presence of tooth sensitivity
- •Difficulty in brushing due to tooth decay
- •History of donation of blood (one unit) within 3 months prior to study check-in or difficulty in donating blood.
- •Participation in a drug research study within past 3 months.
结局指标
主要结局
Changes in blood glucose levels
时间窗: Baseline (0.00) to 15, 30 and 60 minutes post application of toothpaste
次要结局
- Changes in salivary pH(Baseline (0.00) to 15, 30, 60, 120 and 180 minutes post application of toothpaste.)
- To examine the subject’s acceptance by assessing palatability questionnaire(Within 15 minutes of post brushing)
研究者
Dr N Srikanth
AnaCipher Clinical Research Organisation