Pre-Clinical & Clinical Studies on Poly Herbal Anti-Diabetic Formulation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- glycated hemoglobin (HbA1c)
研究概览
简要总结
The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is
- Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics
- Is the herbal combination therapy is safe for human use
- Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID.
- The recruited patients will continue the assigned therapy for at least six months
- They visit the clinical trial OPDs fortnightly
- They will record their fasting blood glucose with the glucometer at least two to three times a week and get the basal tests done in three-month time
详细描述
Preclinical evaluation studies including stability, dissolution and anti-microbial testing were performed. The formulation was also subjected to gas chromatography-mass spectrometry (GCMS). The powdered formulation was analyzed for LD-50 followed by two-center, unblinded, non-randomized controlled clinical trial with convenient sampling was conducted over 24 weeks in 500 adults with T2DM (HbA1c 7.5-10%). Participants were assigned to receive either polyherbal capsules (~500 mg three times daily, n = 250) or metformin (500 mg three times daily, n = 250). Primary outcome was HbA1c reduction; secondary outcomes included fasting/postprandial glucose, urinary protein, urinary glucose, lipid profile, body weight, and safety. Statistical analyses were performed using two-way ANOVA and unpaired t-tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having Type II Diabetes Mellitus.
- •Patients agree willingly to use study medicine throughout the study
- •Patients having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
- •Patients over 30 years of age.
- •Patients of both genders will be included in the study.
排除标准
- •Patients who do not agree willingly to participate in research.
- •Patients having history of any chronic organ failure.
- •Patients having history of any amputation.
- •Patients having history of treated or diagnosed cancer of any organ.
- •Pregnant and lactating mothers.
- •Patients who are having brittle Diabetes
- •Known under treatment cases of psychiatric disorders
研究组 & 干预措施
Metformin - control are of the study
Metformin is standardized hypoglycemic agent with global accepted efficacy & safety
干预措施: Metformin (Drug)
DIAB-PHC1 - Treatment arm of the study
The investigational formulation consisted of Syzygium cumini, Momordica charantia, Wrightia tinctoria and Gymnema sylvestre. Raw plant materials were procured from local herbal markets and authenticated shade dried and powdered. The powder was capsulated with avverage weight of 500 mg /capsule. Capsules were given TID with meals to the patients
干预措施: DIAB-PHC1 (Drug)
结局指标
主要结局
glycated hemoglobin (HbA1c)
时间窗: From two weeks to six months time period
The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose.
次要结局
- Urinary Proteins(At least Six months)
- Urinary Glucose(6 months)
研究者
Abdul Bari
Head of Clinical Trials
Hamdard University