A Single blind, randomized, parallel group study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in signs and symptoms of Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)
研究概览
简要总结
This study is designed as a single centric open trial in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. This study is designed as a multi-centric, controlled trial in patients with DM Type II. After screening, participants will be divided into 2 arms. First arm will receive the study drug*-* UNIM-D 2000 Powder 5 gm BD ½ hour before meals while the second arm will receive anti-diabetic drug Metformin 850 mg B.D. The total duration of treatment will be 12 weeks. The participants will be followed once in 2 weeks for all clinical parameters. The laboratory investigations will be done at baseline, 2 weeks and last follow-up as per the CRF. Fasting Plasma Glucose and 2 Hr Plasma Glucose level will be conducted at each follow-up.
Composition of Coded Unani drug UNIM D 2000
UNIM D 2000 is a compound Unani formulation containing Gurmar Buti (Gymnema sylvestris R.) Gilo (Tinospora cordifolia W.), Maghze Jamun (Syzygium cumini L.) etc. These single drugs have been described for the treatment of Ziabetus Sukkari (Diabetes Mellitus) in classical Unani literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender in the age group of 18-65 years 2.HbA1c level ≥ 7% 3.Both newly diagnosed and known case of Type 2 DM may be included 4.Fasting plasma glucose levels between 126 and 200 mg/dl Or 5.2hr plasma glucose levels between 200 and 300 mg/dl And 6.Presence of any of the following symptoms and signs of diabetes mellitus: Utash mufrit (Polydipsia) Kasrat al-Bawl (Polyuria) Kasrat al-Ishtiha (Polyphagia) Bawl Layli (Nocturia) Iya (Fatigue) Naqs al-Wazn (Loss of Weight) Burning sensation in palm and soles Sadr (Giddiness) Naqs al-Shahwa (Loss of Libido) Duf al Hadm Bawl-e-raqueeque (lighter urine) with Kasrat al-Bawl Bawl-e-sufed (colourless urine) with Kasrat al-Bawl.
排除标准
- •1.HbA1C ≥ 8% 2.Subjects with fasting plasma glucose level >200 mg/dl and /or PP plasma glucose level >300 mg/dl 3.Family history of Type 1 DM 4.Known cases of Metabolic syndrome 5.Diabetes Mellitus-Type 1 or subjects on Insulin therapy 6.Diabetes Mellitus associated with complications of Ketoacidosis 7.Patients on systemic corticosteroids/ disease modifying agents 8.Known cases of Ischemic Heart Disease/ Hyperlipidemia 9.Liver disorders SGPT >105 IU/L 10.Impaired renal function tests 11.Obese Subjects – BMI >35 12.Pregnant and lactating women 13.Known cases of Malignancy & Epilepsy 14.Known cases of any disorder requiring long-term treatment.
结局指标
主要结局
Improvement in signs and symptoms of Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)
时间窗: 12weeks
次要结局
- Haematological and biochemical assessment for safety assessment(12weeks)