Clinical study to Evaluate Efficacy and Safety of EL/DM/01 in participants with Type 2 Diabetes mellitus.
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
- 2
- 主要终点
- 1. Change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent).
研究概览
简要总结
It is a randomized, double blind, multi-center, placebo controlled, prospective, interventional, clinical study to evaluate efficacy and safety of EL/DM/01 in participants with Type 2 Diabetes mellitus. The study will be carried out at 5 to 6 centers in India. The study will have to cohorts. In cohort 1, 60 participants with type 2 diabetes mellitus who are taking oral hypoglycemic agents on regular basis will be completed. In cohort 2, 60 participants with newly diagnosed type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin will be completed. For both the cohorts, subjects will be asked to consume given study product in a dose of 2 tablets twice daily orally after meals with water for 90 days. The primary objectives of the study will be to assess change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent) and change in quality of life assessed on QOLID. The secondary objectives of the study will be to assess change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl), change in Fasting Serum Insulin, change in HOMA-IR score, change in clinical symptoms of Type 2 DM, difference in requirement of Oral Hypoglycemic agents, monthly change in weight and BMI, change in global assessment for overall change by subject and investigator, tolerability of study products and change in laboratory parameters on day -7, day 0, day 30, day 60 and day 90.
Results and Observations:
Cohort 1
The study concludes that use of EL/DM/01 tablets showed significant reduction in HbA1c and Blood sugar (PP) levels in a dose of 2 tablets twice a day for a period of 90 days. There was a significant reduction in symptoms associated with diabetes like polydipsia and fatigue. Also, significant improvement in quality-of-life parameters as measured on QOLID was observed with the use of EL/DM/01. The use of EL/DM/01 was found to be safe as observed with no significant change in bio-chemical laboratory parameters, vitals, clinical symptoms and adverse events. The study concludes that EL/DM/01 can be safely recommended for Diabetes.
Cohort 2
The study concludes that use of EL/DM/01 showed significant reduction in HbA1c and Blood sugar (PP) levels in a dose of 2 tablets twice a day for a period of 90 days. There was a significant reduction in symptoms associated with diabetes like polyuria, polyphagia, polydipsia and fatigue. Also, significant improvement in quality-of-life parameters as measured on QOLID was observed with the use of EL/DM/01. The use of EL/DM/01 was found to be safe as observed with no significant change in bio-chemical laboratory parameters, vitals, clinical symptoms and adverse events. The study concludes that EL/DM/01 can be safely recommended for Diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with type 2 diabetes mellitus and are taking oral hypoglycemic agents on regular basis Cohort 2
- •Patients newly diagnosed with type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin For Both the Cohorts: 2.Patients having HbA1C value between 6.5 to 9.5 percent (both inclusive) at screening.
- •3.Patients having Fasting Plasma Glucose between 126 to 250 mg per dl (both inclusive) at screening.
- •4.Patients having postprandial glucose not more than 350 mg per dl at screening 5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia, acute ischemia.
- •6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is greater 2 years post menopause.
- •Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
排除标准
- •For Both Cohorts:
- •Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
- •Patients taking Insulin for the management of Diabetes
- •Patients with known history of chronic hepatic or renal disease.
- •Patients with known history of malignancy.
- •Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
- •Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
- •Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •History of Use of any other investigational product within 1 month prior to randomization
- •Known history of hypersensitivity to ingredients used in study product
- •Pregnant and Lactating females.
- •Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results.
结局指标
主要结局
1. Change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent).
时间窗: Day -7, day 0, day 30, day 60 and day 90
2. Change in quality of life assessed on QOLID
时间窗: Day -7, day 0, day 30, day 60 and day 90
次要结局
- 1. Change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl).(2. Change in Fasting Serum Insulin)
研究者
Dr Shishir P Pande
Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik