Treatment of Indigestion with Unani medicine Jawarish-e-Muqawwi-e-Meda

Phase 3

Recruiting

Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary: This study is designed as a multi centric open trial in patients with **Duâ€™f-al-Miâ€™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

Recruitment & Eligibility

Inclusion Criteria

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) 3.
Who meets Rome IV criteria for functional dyspepsia 4.
In addition to the above, patients having any / all of the following epigastric bloating excessive belching, nausea.

Exclusion Criteria

Patients below 18 year and above 65 year of age 2.
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 4.
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).

Primary Outcome Measures

Name	Time	Method
Therapeutic efficacy of the study drug will be assessed on the basis of Response recorded using 05 score Likert dyspepsia incidence scale.	At every 14th day of treatment for 4 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.	At baseline and after 4 weeks

Locations (2): Clinical Research Unit
🇮🇳
Nimar, MADHYA PRADESH, India
Regional Institute of Unani Medicine (RRIUM)
🇮🇳
Patna, BIHAR, India
Clinical Research Unit
🇮🇳Nimar, MADHYA PRADESH, India
Dr Yasmin Fatima
Principal investigator
8827166845
yas.fatima2014@gmail.com