Clinical Validation of Unani Pharmacopoeial Formulation Safoof Chobchini in Niqris (Gout)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Improvement in sign 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 at every 2 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Safoof-e-Chobchini
| S.No. |
Ingredients
Botanical/Scientific name46
Quantity
|1.
Chobchini
Smilax china
40 gm.
|2.
Sana
Cassia angustifolia
25 gm.
|3.
Ushba Maghribi
Smilax aristolochiaefolia
20 gm.
|4.
Bisfaayej
Polypodium vulgare
20 gm.
|5.
Suranjan
Colchicum luteum
10 gm.
|6.
Aftimoon
Cuscuta reflexa
10 gm.
|7.
Gul-e-Surkh
Rosa damascena
10 gm.
|8.
Sandal Safaid
Santalum album
10 gm.
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
- •(All of the following)
- •Patients of either sex in the age group of 18-65 years
- •Serum uric acid level: normal or above normal
- •Diagnosed cases of gout as per the ACR/ EULAR-2015 criteria for gout presenting with any of the following symptoms and signs:
- •Joint Pain [especially first metatarsophalangeal (MTP) joint]
- •Tenderness
- •Swelling 7.
排除标准
- •(Any of the following)
- •Clinical conditions involving joints e.g. Osteo-arthritis, Rheumatoid arthritis, Rheumatic arthritis
- •Pregnant and lactating women
- •Patients having any systemic diseases such as hypertension, diabetes mellitus, cardiovascular/cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis
- •Patients with recent H/O dengue, chikungunya and viral fever
- •Grade-2 obesity (BMI ≥ 35)
- •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 sign and symptoms of Niqris (Gout)
时间窗: 6 weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)