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临床试验/CTRI/2024/06/068929
CTRI/2024/06/068929尚未招募4 期

Effectiveness And Safety of Nutritional Supplement Momordica Charantia in Type 2 Diabetes Mellitus:Randomised Open Label Study- PG Dissertation

Kancherla Narasimha Abhinav Kaushal1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年6月27日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
To Assess the Effect of Momordica Charantia (Mc) Supplement on Blood Sugar and HbA1c In Type 2 Diabetic Patients Receiving Oral Antidiabetic Medications

研究概览

简要总结

Type 2 diabetes mellitus (type2 dm) is one of the major health problems and it is an important cause of morbidity and mortality. Diabetes mellitus is a growing global public health problem, and it is characterized by hyperglycemia. The developing and underdeveloped countries have recently witnessed an increase in the prevalence of diabetes mellitus.  Uncontrolled diabetes can lead to increased risk of macrovascular (cardiovascular, cerebrovascular, and peripheral artery disease) and microvascular (diabetic retinopathy, nephropathy, and neuropathy) complications. Intervention in the form of diet and exercise can delay the onset of diabetes and complications. The initial treatment includes the use of oral antidiabetic medications and insulin can be considered in these patients when blood sugar is inadequately controlled.   Momordica charantia (mc), known as bitter melon, has been reported to have antiviral, antibacterial, anti-cancer, and immune-modulating properties. The active components of mc are charantin, vicine, and polypeptide p which are structurally similar to animal insulin. The probable mechanisms of action include increased insulin-like effects, stimulation of pancreatic secretion leading to decreased hepatic gluconeogenesis, increased hepatic glycogen synthesis, and increased peripheral glucose oxidation. Momordica charantia has been widely used as a complementary or alternative therapy for treating diabetes mellitus in many other countries. There are few studies regarding the effect of Momordica charantia as an adjuvant for type 2 diabetes mellitus especially in India. This study will give us the efficacy and safety of Momordica charantia on blood sugar levels in type 2 diabetes mellitus patients who are on oral anti-diabetic medications.

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
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient with type 2 diabetes mellitus Patients receiving two drugs (Sulfonylureas (Glimepiride) + Metformin) for a minimum period of 12 weeks Patients with HbA1c 6.5 To 8%.

排除标准

  • Patients with type 2 diabetes mellitus receiving insulin Patients with liver dysfunction Patients who are on treatment with either steroids or immunosuppressive agents Pregnancy or Lactation Patients with renal impairment.

结局指标

主要结局

To Assess the Effect of Momordica Charantia (Mc) Supplement on Blood Sugar and HbA1c In Type 2 Diabetic Patients Receiving Oral Antidiabetic Medications

时间窗: Blood sugar,HbA1c and adverse effects at 0(baseline),Week 6,Week 12

To assess adverse effects of Momordica charantia supplement using WHO causality assessment scale

时间窗: Blood sugar,HbA1c and adverse effects at 0(baseline),Week 6,Week 12

次要结局

未报告次要终点

研究者

发起方
Kancherla Narasimha Abhinav Kaushal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kancherla Narasimha Abhinav Kaushal

Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research

研究点 (1)

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