An Open Label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial Formulation Qurs e Atash in Humuzat e Meda(Hyperacidity)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Improvement in signs and symptoms of Humuzat-e-Meda(Hyperacidity)
研究概览
简要总结
This study is designed as a single arm trial in patients with Humuzat-e-Meda (Hyperacididty). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Qurs-e-Atashtwo tablets thrice daily with water after meals for six weeks. The patients will be assessed at every two 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 Qurs Atash
| S. No. |
Ingredients
Botanical Name
Quantity
|1
Maghz-e-Tukhm-e-Kaddu
Cucurbitamoschata
40g
|2
Maghz-e-Tukhm-e-Khiyarain
CucumissativusLinn*.*
CucumismeloLinn.
40g
|3
Maghz-e-Tukhm-e-Khiyar
CucumissativusLinn*.*
40g
|4
Tukhm-e-Khurfa
Portulacaoleracea
40g
|5
Samagh-e-Arbi
Acacia Arabica
20g
|6
Nishasta
Carbohydrate
20g
|7
Kateera
CochlospermumreligiosumLinn*.*
20g
|8
Sandal Safaid
Santalum album Linn.
20g
|9
Kafoor
Cinnamomumcamphora
5g
|10
Loab-e-Aspaghol
Plantagoovata
Q.S.
|11
Ma-ul-Shaeer
Barley Water
Q.S.
|12
Aab-e-Kaddu
Water of Cucurbitamoschata
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
- •Subjects of either sex in the age group of 18-65 years
- •Subjects presenting with any of the following symptoms: Retrosternal burning Epigastric pain with retrosternal heaviness Waterbrash Anorexia Nausea or Vomiting SourBelching Sour/Bitter Taste Indigestion Fatigue.
排除标准
- •Pregnant/Lactating women
- •History of previous GIT surgery
- •Any systemic diseases like Cardiovascular, Respiratory, Hepato-Biliary and Renal Diseases
- •Any metabolic diseases like Diabetes
- •Chronic tobacco chewers or smokers
- •Alcoholism
- •Allergy/Hypersensitivity to any ingredients of the drug.
- •Known cases of Peptic Ulcer disease, Crohn’s Disease, Zollinger-Ellison Syndrome and Carcinoma of gastro-intestinal tract.
结局指标
主要结局
Improvement in signs and symptoms of Humuzat-e-Meda(Hyperacidity)
时间窗: 2weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)