To evaluate the Safety and efficacy of Unani formulations in the treatment of Hyperacidity

Phase 2

Recruiting

• Conditions: Acute gastritis, hyperacidity,

• Registration Number: CTRI/2013/10/004116
• 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 ***Kasrat- e- Ratubat-e-Hamoozi*  (hyperacidity).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. 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 end of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-11
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

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

Inclusion Criteria

•Subjects in the Age group of 18-60 years •Subjects of both sexes •Subjects presenting with the following symptoms : oRetrosternal burning oEpigastric pain with retrosternal heaviness oAcidic brash oAnorexia oNausea oVomiting oPain relieved after vomiting.

Exclusion Criteria

• •Duodenal ulcer •Peptic ulcer •H/o previous gastric surgery •Presence of cardiac & lung diseases •Pregnancy/lactation •Alcoholism •Diabetes •Stomach carcinoma •Crohn’s Diseases •Allergy/Intolerance to any ingredients of the drug1,9,12.
• •Zollinger Ellison Syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms	6 WEEKS

Secondary Outcome Measures

Name	Time	Method
Outcome TimePoints	Hematological and biochemical assessments for safety

Trial Locations

Locations (3)

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

Regional Research Institute of Unani Medicine, Aligarh; 🇮🇳 Aligarh, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine, Srinagar; 🇮🇳 JAMMU, & KASHMIR, India

Regional Research Institute of Unani Medicine (RRIUM), Patna

🇮🇳Patna, BIHAR, India

DR S MANZAR AHSAN

Principal investigator

06122631106

manzarahsan9@gmail.com