CTRI/2024/03/064215尚未招募4 期
A Prospective, Randomized And Open Label Study To Compare The Efficacy And Safety Of Metformin Versus Metformin And Fluoxetine In Patients Of Type 2 Diabetes Mellitus With Mild Depression - Nil
ot Available0 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
- 4 期
- 状态
- 尚未招募
- 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
- •Diagnosed cases of T2DM
- •HbA1c = 6.5%.
- •FPG = 126 mg/dl (7.0 mmol/l) after 8 hours of Fasting.
- •2-hour plasma glucose = 200 mg/dl (11.1 mmol/l) during an OGTT.
- •In a patient with classic symptoms of hyperglycemia, a random
- •plasma glucose =200 mg/dl (11.1 mmol/l).
- •Diagnosed cases of concomitant Mild Depression according to ICD-11.
- •Patients between the ages of 18-65 years of both sexes.
- •Patients willing to join the study after giving the informed consent
排除标准
- •Patients with Type 1 DM, Diabetes Insipidus, Acromegaly, Cushing’s Syndrome, Thyrotoxicosis, Anaemia in Pregnancy, and Haemoglobinopathies.
- •Patients with any Organic cause of Depression.
- •Any other Psychiatric comorbidities.
- •Any other comorbidities like Cardiovascular, Renal and Hepatic diseases.
- •Special Physiological conditions like Pregnancy and Lactation.
- •Patients using drugs that can induce Diabetes: Corticosteroids, Thiazides, Phenytoin, Beta Blockers, Antipsychotics, Statins.
- •Patients using drugs that can cause Depression: Corticosteroids; Benzodiazepines – Alprazolam, Clonazepam, Chlordiazepoxide, Diazepam,
- •Flurazepam, Lorazepam, Triazolam; Anticonvulsants – Ethosuximide; Beta Adrenergic Blockers – Metoprolol, Atenolol, Carvedilol; Interferon a; Opiods – Codeine, Meperidine, Morphine, Oxycodone; Statins – Atorvastatin, Fluvastatin, Pravastatin, Simvastatin.
- •Patients using drugs that may interact with Metformin - Acetazolamide, Methazolamide, Dichlorphenamide, Topiramate, Zonisamide,
- •Patients using drugs that may interact with Fluoxetine - Antidepressants - Monoamine Oxidase Inhibitors (MAOI), Selective Serotonin Reuptake
- •Inhibitors (SSRIs), Tricyclic Antidepressants (TCAs); Pimozide; Thioridazone; Tamoxifen; Calcium Channel Blockers; Cyproheptadine;
- •Amino Acids L-Dopa and L-Tryptophan; Anorexiants - Fenfluramine, Anticonvulsants – Carbamazapine, Phenytoin; and Anxiolytics – Alprazolam,
- •Buspirone, Diazepam.
研究者
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