Clinical Validation of Unani Pharmacopoeal formulation Safoof e Teen in Zaheer (Dysentery)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Improvement in sign and symptoms of Safoof-e-Teen in Zaheer (Dysentery)
研究概览
简要总结
This study is a multicentric open trial in patients with Zaheer (Dysentery) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 0,1,2,4,6 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 1 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of SafoofTeen
| S. No. |
Ingredients
Quantity
|1.
Aspaghol
1 part
|2.
Tukhm-e-Raihan
1 part
|3.
Tukhm-e-Mako
1 part
|4.
Nishasta-e-Gandum
1 part
|5.
Samagh-e-Arabi
1 part
|6.
Gil-e-Armani
1 part
|7.
Tabasheer
1 part
|8.
Tukhm-e-Hammaz Biryan
1 part
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
- •Patients of either sex in the age group 18-65 years.
- •Patients of ZahÄ«r (Dysentery) having the following signs and symptoms: (i) 2-8 small-volume, semiformed or unformed stools/day (ii) BarÄz DamwÄ« (Bloody Stools) and/or BarÄz MukhÄtÄ« (Mucoid Stools) (iii) E.
- •histolytica Cysts or Trophozoites in stools With or without any of the following: Maghs (Tenesmus) Waja‘ al-Batn Asfal (Lower Abdominal Pain) ĪlÄm al-Batn Asfal (Lower Abdominal Tenderness).
排除标准
- •Patients having diarrhoea with >8 stools/day
- •Moderate or severe dehydration
- •Fever (≥101 °F)
- •Patients having amoebic dysentery with any associated severe complications, e.g., fulminant colitis with perforation, paralytic ileus, toxic megacolon, ameboma, and liver abscess.
- •Clinical evidence of coexisting acute systemic illnesses
- •History or clinical evidence of chronic diseases requiring long-term treatment, e.g., DM, hypertension, tuberculosis, HIV infection, chronic liver disease, CKD, coeliac disease, IBD, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.
- •Pregnant and lactating women
- •H/o Addiction (alcohol, drugs)
- •H/o Hypersensitivity to the study drug or any of its ingredients.
结局指标
主要结局
Improvement in sign and symptoms of Safoof-e-Teen in Zaheer (Dysentery)
时间窗: six weeks
次要结局
- Hematological and biochemical assessments for safety(six weeks)