An Open Labeled, Multicenter, Prospective, Clinical Study to Evaluate the Suitability for Consumption of Chyawanprakash in Controlled Type II Diabetic Patients.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- 1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values.
研究概览
简要总结
This study is an open labeled, multicenter,prospective, clinical study to evaluate the suitability for consumption ofChyawanprakash in controlled Type II Diabetic Patients that will be conductedin three centers in India. The drug Chyawanprakash will be given in a dose of 1teaspoonful twice a day orally after meals for 90 days. The primary outcomemeasures will be assessment of pre andpost treatment changes in HbA1c % (Glycosylated Hemoglobin %) values and post-treatment physician global assessment of overallsafety. The secondary outcomes will be monthly assessment of changes in fasting &postprandial plasma glucose levels, assessment of adverse drug reaction,assessment of post-treatment clinically significant abnormal laboratoryparameters, assessment of clinicalsymptoms of diabetes, assessment of changes in pre and post treatment of seruminsulin (fasting state) levels, monthly assessment of changes inmicro-albuminurea, assessment of changesin dose of OHAs and assessment of Quality of Life (On WHO Scale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / polydrug oral anti-diabetic therapy.
- •2.Subjects having HbA1c value below 8% at screening.
- •3.Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening.
- •4.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum.
- •A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1.Subjects on Insulin therapy.
- •2.Subjects suffering from Type I DM or type of Diabetes mellitus other than Type II.
- •3.Subjects having known hepatic or renal disease.
- •4.Subjects having an active malignancy.
- •5.Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
- •6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
- •7.Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •8.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •9.Subjects using any other investigational drug within 1 month prior to recruitment 10.Known hypersensitivity to any of the ingredients used in study drug 11.Pregnant and Lactating females.
- •12.Subjects participating in another Clinical trial 13.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
结局指标
主要结局
1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values.
时间窗: 3 month
2.Post-treatment Physician global assessment of overall safety of Dabur Chyawanprakash
时间窗: 3 month
次要结局
- 1.Monthly assessment of changes in fasting & postprandial plasma glucose levels(2.Assessment of Adverse Drug Reaction)