Clinical Validation of Unani Pharmacopoeial Formulation Jawarish-e-Muqawwi-e- Meda in Duf-al-Mida (Functional Dyspepsia)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Therapeutic efficacy of the study drug will be assessed on the basis of Response recorded using 05 score Likert dyspepsia incidence scale.
研究概览
简要总结
This study is designed as a multi centric 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 14th day for four weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition ofJawarish-e- Muqawwi-e- Meda:
| S. No. |
Ingredients
Botanical Names
Quantity
|1.
Mastagi
Pistacia lentiscus Linn.
05 g
|2.
Sumbul-ut-teeb
Valeriana Jatamansi De.
05 g
|3.
Qaranful
Syzygium aromaticum (L.)
05 g
|4.
Ood
Aquilaria agallocha Roxb.
10 gm
|5.
Sazaj Hindi
Cinnamomum Tamala Nees &
Eberm.
10 gm
|6.
Zarnab
Taxus baccata L.
10 gm
|7.
Sad Kufi
Cyperus rotundus Linn.
10 gm
|8.
Darchini
Cinnamomum Zeylanicum Blume
10 gm
|9.
Dana-e-Heel Khurd
Elettaria cardamomum Maton
20 gm
|10.
Zarishk
Berberis aristata DC.
20 gm
|11.
Gul-e-Surkh
Rosa Damascena Mill.
20 gm
|12.
Gaozaban
Borago Officinalis Linn.
20 gm
|13.
Qand Safaid
Sugar
2 times of all
ingredients
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 any sex in age group between 18-65 years.
- •Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, and epigastric burning sensation)
- •Who meets Rome IV criteria for functional dyspepsia
- •In addition to the above, patients having any / all of the following epigastric bloating excessive belching, nausea.
排除标准
- •Patients below 18 year and above 65 year of age
- •Patients with systemic illness e.g. Diabetes/Hypertension/Tuberculosis/Anemia.
- •Known case of Gastric peptic ulcer with H.
- •pylori Infection or reflux esophagitis within the past 6 months were excluded
- •Gastro intestinal bleeding e.g. Hematemesis or Melena.
- •Known case of gastrointestinal surgery.
- •Known cases of Intra-abdominal malignancy (e.g. stomach/Pancreas/Liver or Gastricleiomyoma /Leiomyosarcoma/ Malignant Lymphoma).
结局指标
主要结局
Therapeutic efficacy of the study drug will be assessed on the basis of Response recorded using 05 score Likert dyspepsia incidence scale.
时间窗: At every 14th day of treatment for 4 weeks
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline and after 4 weeks)