Clinical Validation Study of Unani Pharmacopoeial Formulation Habb -e- Leemun in Niqris (Chronic Gout)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- The efficacy of the Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire.
研究概览
简要总结
This study is designed as a Multi-centric open trial in patients with Niqris (Chronic Gout). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. Efficacy and safety parameters will be assessed clinically and recorded every two weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
The ingredients of the Habb-e-Leemun.
| S. No. |
Ingredients
Scientific Name
Quantity
|1. 1.
Post Illaichi kalan (Soktha)
Elettaria cardamomum
25 gm
|2. 2.
Post Halila Zard
Terminalia Chebula
50 gm
|3. 3.
Chhaliya Sokhta
Acacia Catechu Wild (Fruit)
25gm
|4. 4.
Habbul Neel (Kala dana)
Indigofera Tinctoria
25gm
|5. 5.
Kath Safaid
Acacia Catechu Wild (Extract)
25gm
|6. 6.
Murdar Sang
Triplumbic Tetroxide
50gm
|7. 7.
Aab-e-Leemu
Citrus Limon
150ml
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Conformed diagnosis of gout meeting ACR criteria (American College of Rheumatology Criteria) for gout.
- •History of recurrent gout flares (more than 2 per year).
- •Persistent symptoms such as joint pain, swelling, or tophi (visible urate deposits) present for at least six months.
- •Chronic hyperuricemia (serum uric acid equal or more than 6.8).
排除标准
- •Known cases of joints diseases (Osteoarthritis, Osteomyelitis, Rheumatoid Arthritis) except Gout.
- •Patients with systemic diseases like Diabetes Mellitus, Hypertension, and Cardiovascular diseases.
- •Grade-2 obesity (BMI more than 35).
- •Hepatic and renal insufficiency and any malignancy.
- •Patients on drugs that increase uric acid levels.
- •(Thiazide diuretics) or decrease calcium levels (furosemide).
- •Pregnant and lactating women.
结局指标
主要结局
The efficacy of the Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire.
时间窗: At baseline, at first follow up and at the end of treatment. i.e., 0, 2nd, 6th weeks
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT, KFT,Serum Uric acid, HbA1c, CRP and Urine Examination: Routine & Microscopic.
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)