CTRI/2019/04/018632已完成2 期
A Clinical Study of DB 07, an Ayurvedic preparation intended to manage blood sugar level in subjects suffering from Type 2 Diabetes Mellitus - DM2 Study
Emami Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects aged between 30 - 70 years with BMI between 18 and 33 kg/m2.
- •2.Subjects diagnosed with the type 2 diabetes mellitus based on the physical, medical and laboratory assessments (fasting plasma glucose >126mg/dL <= 200 mg/dL, and/or HbA1c > 6.5% and poorly controlled glycemic status (<=9%), or 2 hour post-prandial sugar >200mg/dL to <=300 mg/dL).
- •3.Subjects on life style modifications with allopathic anti-diabetic therapy namely biguanides (metformin) and sulfonylureas (2nd/3rd Generation).
- •4.Subjects who are willing to maintain a diet plan applicable for diabetic subjects during the course of the study.
- •5.Subjects should be active; considered generally healthy as per health history and routine clinical investigations.
- •6.Ability to understand the risks and benefits of the protocol.
- •7.Subjects who provide written informed consent and agree to be available for regular follow up throughout the study duration.
排除标准
- •1.Subjects with clinical history of severe endocrine disorders which according to the physician might interfere with the trial medication
- •2.Subjects suffering from Type 1 Diabetes mellitus or patients diagnosed with type 2 diabetes mellitus receiving insulin, or subjects with poorly controlled glycemic status with HbA1c >9% and/or have severe complications of diabetes mellitus viz., neuropathy, nephropathy, retinopathy Subjects with concurrent serious hepatic dysfunction (defined as AST and/or ALT >3 times of upper normal limit) or renal dysfunction (defined as S. creatinine >1.2mg/dL),or uncontrolled pulmonary dysfunction (asthmatic and Chronic obstructive pulmonary disease (COPD) patients), subjects with known conditions like HIV or any other concurrent severe disease.
- •3.Subjects having a history stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •4.Subjects with the history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •5.Subjects consuming alcohol ( >2 standard drinks per week) or smoking ( >5 cigarettes a day), and who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •6.Subjects who underwent major surgical procedures in last 6 months.
- •7.Pregnant/lactating women; subjects on steroids, oral contraceptive pills or oestrogen replacement therapy
- •8.Evidence of malignancy; suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, psycho-neuro-endocrinal disorders, etc
- •9.Subject who has illness as per the opinion of investigator which would interfere to participate into the study.
- •10.H/O hypersensitivity to any of the trial drugs or their ingredients and subjects who participated in a clinical study within the last 180 days prior to recruitment or currently involved in another study, or other conditions as per the Investigator may jeopardize the study will be excluded from the trial.
研究者
相似试验
已完成
3 期
AYURVEDIC TRAETMENT OF DIFFICULTY IN URINATION (Mutra Roga)CTRI/2022/10/046538Dept of Shalya Tantra60
已完成
2 期
Role of Triphaladi mouthwash in patients of dental caries.CTRI/2018/02/012165IPGT and RA40
尚未招募
2 期
Study Of Parikartikantak Ghrit in Fissure-in-AnoCTRI/2023/08/056040Govt PG Ayurvedic College and Hospital, varanasi
进行中（未招募）
3 期
Prevention and management of neurodegenerative disorders by an Ayurvedic formulatioCTRI/2014/12/005312Department of Science Technology
已完成
2 期
A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus )CTRI/2009/091/000702Hamdard National Foundation New DElhi50