CTRI/2024/04/066012尚未招募Phase 3 4
A RANDOMIZED, OPEN LABEL, PLACEBO CONTROLLED STUDY TO EVALUATE THE ROLE OF TAB NISHA-AMALAKI AND MAHADADIMADI GHRITA AS ADJUVANT THERAPY IN TYPE 1 DIABETES (SAHAJA PRAMEHA) IN CHILDREN
All India Institute of Ayurveda, New Delhi1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年5月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in HBA1C, FBS, PPBS level and Serum Insulin
研究概览
简要总结
patients of diabetes mellitus type I will be randomly selected into two groups group 1 will be provided with Nisha-amlaki tablet and Mahadadimadi ghrita along with SOC while patients of group 2 will be given SOC patients will be kept under follow for period of 1month
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
- 2.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 02 -16 years.
- •Pre-diagnosed cases of T1DM (Type 1 diabetes)
- •Patients having FBS ≥126mg/dl, PPBS ≥200 mg/dl, HbA1c ≥ 6.5%
- •Requirement of insulin as the initial mode of treatment at the time of diagnosis of diabetes.
- •Brittle diabetes (mellitus)
- •Diabetes (mellitus) due to autoimmune process
- •Diabetes (mellitus) due to immune mediated pancreatic islet beta-cell destruction
- •Idiopathic diabetes (mellitus)
- •Juvenile onset diabetes (mellitus).
排除标准
- •Patient age less than two year and more than 16 year
- •Patients of type 2 diabetes.
- •Any systematic and severe illness requiring hospitalization.
- •History of hypersensitivity to any drug.
- •Patients whose parents are not willing to give consent for clinical trial.
- •Active case of DKA and blood glucose level more than 600 mg/dl.
- •Ketosis-prone diabetes (mellitus), gestational diabetes.
- •Hyperglycemia NOS
- •Neonatal diabetes mellitus
- •Post pancreatectomy diabetes mellitus.
- •Post procedural diabetes mellitus.
- •Secondarydiabetes mellitus NEC.
结局指标
主要结局
Reduction in HBA1C, FBS, PPBS level and Serum Insulin
时间窗: FBS, PPBS level and Serum Insulin. Baseline, after every month and Hb1AC assessed Baseline, after 3rd month and | 6 | th months and for the assessment in the present study.
次要结局
- ➢ Reduction in dose of insulin per day.(25)
研究者
Gourav Kumar Rathor
All India Institute of Ayurevda, New Delhi
研究点 (1)
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