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临床试验/CTRI/2019/02/017801
CTRI/2019/02/017801尚未招募3 期

Clinical Validation of Unani Pharmacopoeial Formulation Majoone-Sangdana Murgh in Du‘f al-Mi‘da (Functional Dyspepsia)

Central Council for Research in Unani Medicine CCRUM3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年2月28日最近更新:

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)

研究者

发起方
Central Council for Research in Unani Medicine CCRUM
申办方类型
Research institution

研究点 (3)

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