CTRI/2025/11/098193尚未招募不适用
A randomized,open-label,two-group, parallel study to evaluate the efficacy and safety of AS GEL in type II diabetic patients.
PR Nine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
This study is a randomized, open-label, two-group, parallel trial designed to evaluate the efficacy and safety of AS JEL in patients with Type II Diabetes Mellitus. A total of 50 participants (25 per group), aged 35–75 years with a BMI >23 kg/m² and diagnosed with diabetes within the past two years, will receive treatment for 10 weeks. The primary endpoints are changes in HbA1c and fasting blood glucose, while secondary endpoints assess oral dryness using the CODS index, Challacombe scale, and Xerostomia Inventory. The study aims to determine whether AS JEL can improve glycemic control and alleviate oral dryness symptoms safely in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female elderly individuals aged 35-75 (both inclusive).
- •Patients diagnosed with Diabetes Mellitus from the past two years.
- •Patients who give consent for participation in the study.
- •Patients with a BMI more than 23(Kg/m2).
排除标准
- •Treatment with insulin within the last 3 months before the trial.
- •Impaired liver or/and renal function.
- •Patients having an allergy to oral moisturizing creams.
- •Patients who had a salivary gland removal, and patients with Sjogrens syndrome.
- •Patients having chronic complications of Diabetes, Retinopathy, Neuropathy and Nephropathy.
- •Patients with the Presence of any oral mucosal lesion.
- •Those with pregnant or lactating, or women of childbearing age who do not agree to use medication during the trial.
- •Participants who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period.
- •Those who are deemed unable to comply with the test requirements or otherwise considered as unsuitable according to the investigators opinion.
研究者
Dr Venkatesh S
Vagus Super Speciality Hospital Pvt.Ltd.
研究点 (2)
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