Clinical Validation Study of Unani Pharmacopeial Formulation Jawarish-e-Javed in Zof-e Meda (Functional dyspepsia)
试验速览
- 阶段
- 2 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 the signs and symptoms of Zof-e Meda (Functional dyspepsia). Which will be assessed on the basis of Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ).
研究概览
简要总结
This study is designed as a single centric open trial in patients with Zof-e Meda (Functional dyspepsia) . After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at baseline and every two weeks of the treatment. (i.e., 0, 2th, 4th and 6th week) . This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 06 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy (i.e., 0, and 6th week).
Composition of Jawarish-e- Javed:
| S. No. |
Ingredients
Botanical / Scientific Name
Part used
Quantity
|1.
Jauzbuwa
Myristica fragrans Houtt.
Fruit kernel
25 gm
|2.
Bisbasa
Myristica fragrans Houtt.
Aril
25 gm
|3.
Qaranful
Syzygium aromaticum Linn.
Flower bud
25 gm
|4.
Darchini
Cinnamomum verum J.Presl
Stem bark
25 gm
|5.
Sumbul-ut-teeb
Nardostachys jatamansi (D. Don) DC
Rhizome
25 gm
|6.
Sad Kufi
Cyperus rotundus Linn
Rhizome
25 gm
|7.
Amla Munaqqa
Phyllanthus emblica L
Deseeded fruit
25 gm
|8.
Dana Heel Khurd
Elettaria cardamomum (L.) Maton
seed25 gm
|9.
Qand Safaid
Sugar
As such
400 gm
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1-Patients of either sex in the age group of 18-65 years.
- •2-Patients meeting the Rome IV Criteria (Postprandial Distress Syndrome) as under 3-Patients with Mild to moderate dyspepsia as defined by a score ranging between 1-15 as per the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ).
排除标准
- •1- Patients with Severe dyspepsia as defined by a score ranging more then 15 as per the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ).
- •2- Patients showing alarm symptoms (weight loss, anemia, hematemesis, melena, dysphagia, palpable abdominal mass).
- •3- Patients with systemic illness e.g.Diabetes/Hypertension/Tuberculosis/Anemia.
- •4- Known case of Gastric peptic ulcer with H.
- •pylori Infection or reflux esophagitis within the past 6 months were excluded 5- Known case of gastrointestinal surgery.
- •6- Known cases of Intra-abdominal malignancy (e.g. stomach/Pancreas/Liver or Gastricleiomyoma/Leiomyosarcoma/Malignant Lymphoma) 7- Patient requiring long term therapy e.g. Hepatic, Renal or Cardiac Ailments.
- •8- History of surgery related with the gastrointestinal tract more than six months 9- Pregnant and lactating females.
结局指标
主要结局
Improvement in the signs and symptoms of Zof-e Meda (Functional dyspepsia). Which will be assessed on the basis of Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ).
时间窗: At baseline and every two weeks during the treatment period (i.e., at 0, 2nd, 4th, and 6th week).
次要结局
- Haematological and biochemical investigations for safety assessment i.e.,Haemogram, LFT, KFT, stool and Urine R/M.(At baseline and at the end of treatment.( i.e., 0 and 6th week))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)