CTRI/2013/10/004092招募中2 期
A Multi centric, Single Blind, Randomized, parallel group study to compare efficacy and safety of coded unani formulation UNIM 221 with Metformin in patients with Ziabetus Sukkari Qism e Sani (Diabetes Mellitus Type II)
Central Council for Research in Unani Medicine CCRUM New Delhi0 个研究点目标入组 624 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 624
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 in the age group of 18-65 years.
- •2. Fasting plasma glucose levels between 126 and 150 mg/dl
- •3. 2hr plasma glucose levels between 200 and 250 mg/dl
- •(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
- •4. HbA1c level >=6.5%
- •5. Presence of any of the following symptoms and signs of diabetes
- •Utash mufrit (Polydipsia)
- •Kasrat al-Bawl (Polyuria)
- •Kasrat al-Ishtiha (Polyphagia)
- •Bawl Layli (Nocturia)
- •Iâ??ya (Fatigue)
- •Naqs al-Wazn (Loss of Weight)
- •Burning sensation in palm and soles
- •Sadr (Giddiness)
- •Naqs al-Shahwa (Loss of Libido)
排除标准
- •Subjects with fasting plasma glucose level 150 mg/dl and /or PP
- •plasma glucose level 250 mg/dl
- •Subjects on Insulin therapy
- •Diabetes Mellitus-Type I
- •Secondary Diabetes Mellitus
- •Diabetes Mellitus associated with complications of Ketoacidosis
- •Patients on systemic corticosteroids/ disease modifying agents
- •Ischemic Heart Disease/ Hypertension/ Hyperlipidemia
- •Liver disorders SGPT 105 IU/L
- •Impaired Renal function tests
- •Anemia Hb 8 gm/dl in Males and Hb 6 gm/dl in females
- •Obese Subjects â?? BMI 30
- •Pregnant and lactating women
- •Drug addicts/ Alcoholics
- •Malignancy/ Epilepsy
- •Any infective disorder requiring long-term treatment
- •Patient on any other treatment including use of alternative
研究者
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