Clinical evaluation of D-Co-D as stand-alone and with conventional therapy for the management of type 2 diabetes mellitus and improvement in various comorbidities parameters

Dr.JRKs Research and Pharmaceuticals Pvt Ltd1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2025年2月12日最近更新: 2025年1月28日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 300
试验地点: 1
主要终点: 7) K

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

After getting informed consent, 300 subjects will be divided as per the below group

Group 1- JRK D-co-D tablet+ Metformin+ Vidagliptin
Group 2- Madhumeghachoornam+ Metformin+ Vidagliptin
Group 3- Iron tablet ( Siddha) + Metformin + Vidagliptin
D-co-D alone

All the patients alloted in each group based on randomization will be treated with the respective drug (s) for a total period of 6 months. All the blood and organ health parameter will be evaluated on day zero, after 45 days, after 3 months and after 6 months and the treatment response in each group was analysed for statistical signficance.

Evaluation Parameters

Fast blood Glucose 2) Post prandial blood glucose
Random blood glucose 4) Glycated Haemoglobin

Organ Health Details : Na, K, Urea, Creatinine, Uric Acid, Total Protein, Albumin, Bilieubin, Alkaline Phosphatase,Acid Phosphatase, Amylase, Total Cholestrol, Triglyceride, Vit B12, Na in Urine, K oin Urine, Creatinine in Urine, Systolic blood pressure and Diastolic blood Pressure

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 35.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•People who are clinically proven for diabetes mellitus (type 2)
•The duration of the disease between -1-15 years with the age ranged between 35-70 years
•Predominantly on Metformin +Vidagliptin treatment for last 5 months
•Also consulting AYUSH vaid besides diabetologist for AYUSH supplements which is not been objected by the respective diabetologist
•Willing to use JRKâ€™s D-Co-D tablet as per the direction without altering or deviating the main line therapy (Metformin + Vidagliptin)
•The patients who have not shown serious concern on any of the laboratory test parameters that may warrant the patient to be referred to specialized treatment
•Patients who are willing to subject to certain laboratory investigations at entry level, 45 days, three and six month of therapy to ascertain treatment response
•Patients who agree to the CRO and Sponsor to review and use the laboratory test results obtained purely for research purpose, without divulging the identity of the patient and where the medical benefit of JRKâ€™s D-Co-D can be reached out to large section of patients in India and other countries
•Patients who agree to consult the respective diabetologist without fail; where participation in the present observational study will not be construed by the patient such regular consultation of the diabetologist is not require.

排除标准

•Not agreed to any of the criteria mentioned above
•Lactating female and pregnant women
•Patients who may be suffering from infection, other health complications that may require primary medical attention.