To evaluate the Safety and efficacy of Unani formulation in the treatment of Dyspepsia

Phase 2

Recruiting

• Conditions: Functional dyspepsia, Sū’ al-Hadm (Dyspepsia),

• Registration Number: CTRI/2015/02/005528
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Sū’ al-Hadm (Dyspepsia).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

**Composition of Jawarish e Kamooni**

| | | | |

| --- | --- | --- | --- |

| **S. No.**

**Unani Name**

**Scientific Name**

**Weight**



| 1.

Zeera Siyah Mudabbar

*Cuminum cyminum*

350 g



| 2.

Barg-e-Sudab

*Ruta graveolens*

350 g



| 3.

Filfil Siyah

*Piper nigrum*

350 g



| 4.

Zanjabeel

*Zingiber officinale*

350 g



| 5.

Boora-e-Armani

*Borax*

100 g



| 6.

A‘sal or Qand Safaid

*Honey or Sugar*

5 kg

**Compositionof Arq-e- Badiyan**

| | | | |

| --- | --- | --- | --- |

| **S. No.**

**Unani Name**

**Scientific Name**

**Weight**



| 1.

Badiyan

*Foeniculum vulgare*

01 Part



| 2.

Aab

*Oxidane (Water)*

20 Parts

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-02
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1.Patients of either sex in the age group of 18-55 years.
• 2.Patients having abdominal discomfort with any of the following symptoms of Sū’ al-Hadm (Dyspepsia) due to Sū’-i-MizÄj BÄrid: •Abdominal pain •Heartburn •Acid Regurgitation •Eructation •Nausea and Vomiting •Abdominal Distention.

Exclusion Criteria

•Dysphagia •Inflammatory Bowel Disease e.g. Ulcerative colitis, Crohn’s Disease •Palpable abdominal mass •History of Zollinger ellison syndrome •History of sudden weight loss •History of long-term medication •Known cases of cancer, anaemia/ haematemesis/ melaena •Known cases of severe hepatic, renal or cardiac ailments •Diabetes Mellitus •H/o addiction (tobacco chewing, smoking, alcohol, drugs) •Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Sū’ al-Hadm (Dyspepsia)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	2 weeks

Trial Locations

Locations (5)

CENTRAL RESEARCH INSTITUTE, LUCKNOW; 🇮🇳 Lucknow, UTTAR PRADESH, India

Clinical Research Unit (CRU), Kurnool; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Clinical Research Unit (CRU), Meerut; 🇮🇳 Meerut, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

CENTRAL RESEARCH INSTITUTE, LUCKNOW

🇮🇳Lucknow, UTTAR PRADESH, India

DR ZIAUL HAQUE SIDDIQUI

Principal investigator

05222732088

crium_lko@yahoo.co.in