A single centric open label randomized study on efficacy of blood glucose management herbal supplement as an adjuvant in Type-II Diabetes Mellitus patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary endpoint:
研究概览
简要总结
This is a randomized, single centric, open label study to evaluate the efficacy of a Diabetes Herbal Supplement in Type 2 diabetes mellitus patients. The aim of the study is to examine the effects of diabetes herbal supplement on symptoms of Diabetes Mellitus, wellbeing and quality of life. The hypothesis is that symptoms of Type-II Diabetes Mellitus, wellbeing and quality of life will be improved in the herbal supplement administered to subjects with reduction in HbA1c, Fasting and Post prandial Glucose levels. The impact of the supplements on lipids will also be documented.
The study comprises of 3 Phases:
Phase 0- Screening Visit (Day -3 to Day 0)
Phase 1- Baseline Visit (Day 0)
Phase 2- Follow-Up (Day 1 to Day 30)
Phase 3- Follow-Up Visit (Day 90)
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
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Male/ Females subjects between 35-55 years of age
- •Subjects able to communicate effectively.
- •Subjects willing to provide written informed consent
- •In the judgment of the Principal Investigator, able to comply with protocol requirements.
- •Ability to schedule and attend monthly visits for the duration of the study.
- •Subjects with fasting blood glucose levels between 150-250 mg/dL
- •Subjects who are diabetic for one year with standard Diabetic medication
- •Subjects with HbA1C Levels (8% -10%).
排除标准
- •Exclusion Criteria:
- •Contraindications or Hypersensitivity to study product.
- •History or presence of any medical condition or disease according to the discretion of the Investigator.
- •No contraindications to exercise as outlined by the American Endocrine society (ACS).
- •Patients with Fasting glucose levels more than 250 mg/dL.
- •Patients with diabetes associated with retinopathy
- •Patients with Diabetic Nephropathy and Diabetic Neuropathy
- •Patients with Chronic Cardiovascular diseases.
- •Subjects having abnormal findings on complete blood count
- •Subjects with HIV Positive.
- •Subjects having history of high alcohol intake (greater than 2 standard drinks per day).
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •Subjects participated in any clinical study within thirty (30) days prior to screening.
- •Pregnant Women.
结局指标
主要结局
Primary endpoint:
时间窗: Day 0 to Day 90
1.Treatment satisfaction score
时间窗: Day 0 to Day 90
2.Treatment preference
时间窗: Day 0 to Day 90
3.Quality of life scores
时间窗: Day 0 to Day 90
4.Clinical and biochemical markers of Diabetes mellitus
时间窗: Day 0 to Day 90
次要结局
- Secondary endpoints:
研究者
Dr P Sridhar Reddy
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD