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临床试验/NCT06125873
NCT06125873Enrolling By Invitation2 期

Effect of Moringa Leaf Capsules on Glycemic Control of Type 2 Diabetic Patients- an Interventional Study

Islamabad Medical and Dental College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Moringa leaf powder decreases blood sugar level in type 2 diabetic patients.

研究概览

简要总结

A randomized clinical trial will be done on 50 patients , randomly divided into two groups by lottery method to compare the glycemic control in patients of Type 2 Diabetes Mellitus by the use of Moringa Oleifera (MO) capsules. Patients will be given Moringa Oleifera (MO) capsules for 3 months and follow up will be conducted after 3 months to assess glycemic control.

详细描述

Few human studies are reported on Moringa Oleifera (MO), with most trials reported on animals. Based on human studies, the plant has been proposed to decrease glucose levels by increasing insulin secretion and sensitivity and by inhibiting amylase and glucosidase activities proven by animal studies, additional proposed mechanisms of action include increased glucose uptake in the muscle and liver, inhibition of glucose uptake in the intestine, and decreased gluconeogenesis in the liver.

Rationale of this study is to observe the effects of Moringa Oleifera (MO) capsules, a herbal medicine, on lowering Hba1c levels and compare it with the first line drug so that it can be recommended in the guidelines as a supportive treatment option.

A few human studies are reported on the use of Moringa Oleifera (MO), most of trials are reported on animals. In Pakistan no such study is available but people in rural areas take it as a myth to treat different diseases.

Moringa Oleifera (MO) leaves are non-toxic. This has been confirmed by laboratory experiments such as The aqueous extract of leaves was administered orally to 30 male Wistar rats and even in doses of 2000 mg/kg no mortality ensued. Sub-acute toxicity was assessed by administering daily doses of up to 1600 mg kg to male rats, and no signs of serious toxicity were observed on biochemical or haematological tests, or on histopathology of the organs.

According to the International Diabetes Federation, in the year 2022, 26.7% of adults in Pakistan are a victim of diabetes mellitus, making the total number of cases approximately 33,000,000. This alarmingly high number poses not only an enormous risk of health complications but also a huge financial load on patients. A substantial proportion of patients' income is spent on diabetes care. The mean annual direct cost per patient with diabetes was estimated to be 80,000 Rupees. Medications accounted for the largest share (60.4%) of this cost. The WHO has supported the evaluation of medicinal plants and herbs for the management of certain chronic conditions. In recent years there has been exponential growth in the field of herbal medicines and the demand for these is increasing both in developing and developed countries because of their natural origin, fewer side effects and low cost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients of over age 40 with type 2 diabetes
  • The patients who willingly consent

排除标准

  • Patients having Type I diabetes
  • Pregnant women
  • The patients with deranged LFTs and RFTs.
  • Patients having Creatinine levels more than 1.3 mg/dl in man and >1.1mg/dl in female.
  • Patients of Type II diabetes on insulin therapy

研究组 & 干预措施

Metformin

Active Comparator

Metformin 500mg taken orally twice daily

干预措施: Metformin (Drug)

"Moringa+Metformin"

Experimental

Metformin 500mg taken orally twice daily with Moringa Oliefera (MO) capsule 1g once daily before breakfast

干预措施: Metformin (Drug)

结局指标

主要结局

Moringa leaf powder decreases blood sugar level in type 2 diabetic patients.

时间窗: 3 months

Fasting blood glucose tested after 15 days regularly.

It controls blood Glycated hemoglobin level in type 2 diabetic patients.

时间窗: 3 months

Glycated Hemoglobin(Hb A1c) tested after 3 months.

次要结局

  • Moringa leaf powder effect on Systolic Blood Pressure(3 months)
  • Moringa leaf powder effect on Diastolic Blood Pressure(3 months)
  • Moringa leaf powder effect on body weight of patients(3 months)

研究者

发起方
Islamabad Medical and Dental College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Dr. Asma Irfan

Professor and Head of Department

Islamabad Medical and Dental College

研究点 (1)

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