CTRI/2017/11/010711进行中（未招募）2 期
A Randomised placebo controlled phase-II clinical study of an Ayurvedic coded drug â??AYUSH â?? Dâ?? in the management of Type 2-Diabetes Mellitus as add on therapy to Metformin - RADM
Incharge0 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
- 进行中（未招募）
- 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.Patients of either sex aged between 18 to 70 years.
- •2.Diagnosed patient of Type 2 Diabetes having Glycosylated Haemoglobin (HbA1c) between 7% - 9%
- •3.Willing to participate and able to provide signed informed consent.
排除标准
- •1.Subject of type 1 DM or type 2 DM on insulin/OHAâ??s other than metformin/any other AYUSH medication for glucose control.
- •2.Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, nephropathy, retinopathy, etc. which require an urgent treatment.
- •3.Subjects with uncontrolled hypertension (with or without medication >140/90mmHg after 5 mins of rest)
- •4.Subjects with established diagnosis of CAD requiring any procedure in next 6 months â?? angioplasty on bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease.
- •5.Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > greater than ULL),uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects)
- •6.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
- •7.Pregnant / Lactating women.
- •8.Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
- •9.Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- •10.Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
- •11.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •12.Subjects who have completed participation in any other clinical trial during the past three months.
- •Any other condition which the Investigator thinks may jeopardize the study.
研究者
相似试验
已完成
不适用
A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer-C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61PER-142-08MERCK SHARP & DOHME PERU S.R.L.,
进行中（未招募）
1 期
A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune DiseasePrevention of herpes zoster in adults with autoimmune diseaseMedDRA version: 14.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002313-11-ESMerck Sharp & Dohme Corp.340
进行中（未招募）
1 期
A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune DiseaseEUCTR2011-002313-11-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.340
进行中（未招募）
不适用
A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune DiseaseEUCTR2011-002313-11-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.340
进行中（未招募）
1 期
A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune DiseasePrevention of herpes zoster in adults with autoimmune diseaseMedDRA version: 14.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002313-11-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.340