Clinical Validation of Unani Pharmacopoeial Formulation Majoone-Sangdana Murgh in Du‘f al-Mi‘da (Functional Dyspepsia)
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
- 3
- 主要终点
- Improvement in signs and symptoms of Du‘f al-Mi‘da (Functional Dyspepsia)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with **Du‘f al-Mi‘da (Functional Dyspepsia).**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically 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.
Compositionof Majoon-e-Sangdana Murgh
| S. No. |
Ingredients
Botanical / Scientific Name
Quantity
|1.
Gul-e-Surkh
Rosa damascena Mill.
100 g
|2.
Post-e-Sangdana Murgh
Gizzard of the Cock/ Hen
90 g
|3.
Tabasheer
Bambusa arundinacea
90 g
|4.
Behman Safaid
Centaurea behen Linn.
70 g
|5.
Behman Surkh
Salvia haematodes Linn.
70 g
|6.
Sandal Surkh
Pterocarpus santalinus Linn*.*
70 g
|7.
Sandal Safaid
Santalum album Linn*.*
70 g
|8.
Saatar Farsi
Zataria multiflora Boiss*.*
70g
|9.
Kishneez Khushk Biryan
Coriandrum sativum Linn*.*
70 g
|10.
Habb-ul-Aas
Myrtus communis Linn*.*
70 g
|11.
Pudina Khushk
Mentha arvensis Linn*.*
45 g
|12.
Post-e-Berun-e-Pista
Pistacia vera Linn*.*
45 g
|13.
Post-e-Turanj
Citrus medica Linn*.*
45 g
|14.
Post-e-Halela Zard
Terminalia chebula Retz*.*
45 g
|15.
Qand Safaid
Sugar
3 kg
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •· Patients of either sex in the age group of 18-60 · Patients meeting the Rome III diagnostic criteria for PDS.
排除标准
- •· Presence of GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion.
- •· Having overlap syndrome combined with gastro esophageal reflux disease or irritable bowel syndrome · Having alarm symptoms (weight loss, black or tar stool, dysphasia, etc.) · Having any systemic disease (diseases of heart, lung, liver or kidney) or mental illness · History of surgery related with the gastrointestinal tract more than six months ago · Taking drugs which may affect the gastro intestinal tract, such as non-steroidal antiinflammatory drugs and aspirin · Known Allergy to the experimental medications · Pregnant and breastfeeding · Refusing to sign the informed consent.
结局指标
主要结局
Improvement in signs and symptoms of Du‘f al-Mi‘da (Functional Dyspepsia)
时间窗: 6 weeks
次要结局
- Investigations will be done at baseline and end of treatment(6 weeks)
