Clinical Validation of Unani Pharmacopoeial formulation Qurs-e-Ziabetus Khaas in Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Improvement in signs and symptoms of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 12 weeks and the follow-up for all clinical parameters will be conducted every two weeks. Laboratory parameters for safety assessment will be conducted at baseline, after two weeks and at the end of study.
Composition of Qurs-e-Ziabetus Khaas
1. Tabasheer - 25g.
2. Satt-e-Gilo - 25g.
3. Maghz-e-Khasta-e-Jamun - 50 g.
4. Gurmar Buti - 50 g.
5. Kushta-e-Baiza-e-Murgh - 10 g.
6. Kushta-e-Zumurrud - 10 g.
7. Loab-e-Aspaghol - Q.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 sex in the age group of 18-65 years.
- •2.Fasting plasma glucose levels between 126 and 150 mg/dl or 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) and/or 4.Presence of any of the following classical symptoms and signs of diabetes mellitus: •Utashmufrit (Polydipsia) •Kasrat al-Bawl (Polyuria) •Kasrat al-Ishtiha (Polyphagia) •Bawl Layli (Nocturia) •I’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
- •Any one of the following: •Subjects with fasting plasma glucose level >150 mg/dl and /or PP plasma glucose level > 250 mg/dl •Diabetes Mellitus-Type I •Patients on systemic corticosteroids/ disease modifying agents •Ischemic Heart Disease/ Hypertension/ Hyperlipidemia •Liver disorders SGPT >105 IU/L •Impaired Renal function •Anemia: Hb <8 gm/dl in Males and Hb <6 gm/dl in females •Obese Subjects – BMI >30 •Pregnant and lactating women •Any disorder requiring long-term treatment •Patient on any other treatment including use of alternative medicine.
结局指标
主要结局
Improvement in signs and symptoms of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)
时间窗: 12 weeks
次要结局
- Haematological and biochemical assessment for safety assessment(12 weeks)