Clinical Validation of Unani Pharmacopoeial Formulations - MÄjÅ«n-e-SÅ«ranjÄn & Habb-e-AzÄrÄqi in Niqris (Gout)
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 Niqris (Gout)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Niqris (Gout). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 8 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and end of study.
Composition
I. MÄjÅ«n-e-SÅ«ranjÄn
Nameof Ingredients Botanical Name Quantity Actions
1.Suranjan Shireen (Merendera persica) 500 gm Mudir-e-Bawl,Mohallil 2. Sana (Cassia angustifolia) 250 gm Qabiz 3. Zanjabeel (Zingiber officinale) 100 gm Mushtahi,Hazim, Kasir-e-Riyah 4. Zeera Siyah (Carum carvi) 100 gm Hazim,Kasir-e-Riyah, Mudir-e-
Haiz,Ahtbas-e-Haiz 5. Filfil Daraz (Piper longum) 100 gm Sual,Dama, Kali Khansi 6. Asaroon (Asarum europaeum) 100 gm Sara, Laqwa,Falij 7. Asl Or Qand Safaid 3.5kg
II. Habb-e-AzÄrÄqi1. Azaraqi Mudabbar (Strychnosnux-vomica) 20 gm Falij, Laqwa 2. Filfil Siyah (Piper nigrum) 10 gm Zof-e-Qalb, Mushtahi 3. Filfil Daraz (Piper longum) 10 gm Sual, Dama, Kali Khansi 4. Arq-e-Ajwayin (Ptycotis ajowan) Q. S. Hazim, Kasir-e-Riyah
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients of either sex in the age group of 18-
- •â€¢Serum uric acid level: normal or above normal •Patients of gout having any of the following symptoms and signs: Joint Pain (especially first metatarsophalangeal (MTP) joint) Tenderness Swelling Redness.
排除标准
- •â€¢Other diseases involving small & large joints •Pregnant and lactating women •Patients having any systemic diseases such as hypertension, diabetes mellitus, Cardiovascular/Cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis •Obesity (BMI: ≥ 30) •Patients on long term medications •Patients taking drugs which increase serum uric acid levels (thiazide diuretics, etc.) and decrease serum calcium levels (furosemide, etc.).
结局指标
主要结局
Improvement in signs and symptoms of Niqris (Gout)
时间窗: Improvement in signs and symptoms of Niqris (Gout)
次要结局
- Haematological and biochemical assessment for safety assessment(12 weeks)