MedPath

Effect of Unani drugs in Acidity

Phase 2
Conditions
Health Condition 1: K318- Other specified diseases of stomach and duodenum
Registration Number
CTRI/2020/04/024500
Lead Sponsor
ational Institute of Unani Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Symptoms persist at least for 1 month with moderate to severe symptoms (score > 4 on the 7 point Global overall symptoms (GOS) scale).

Exclusion Criteria

1.Patients age below 18 and above 50 year

2.Patients with severe systemic and metabolic diseases

3.History of angina pectoris

4.Pregnant and lactating women

5.Patients with alarming symptoms (unintentional weight loss, recurrent vomiting, dysphasia, hematemesis, Malena, fever, jaundice, anemia.

6.History of any serious gastrointestinal disease including peptic ulcer, malignancy, dysmotility.

7.Previous endoscopic diagnosis of erosive gastro-esophagitis or Barrett esophagus.

8.Gastrointestinal surgery within 30 days.

9.Hemoglobin <9g/dl, Total leukocyte count <3000/ul, Platelet count <75000/ul, AST & ALT >120 IU/L, Serum creatinine >1.5 mg/dl, Occult blood in stool.

10.Treatment history of NSAIDs, H2 receptors blockers, PPI, Prokinetic drugs, sucralfate or other ulcer healing agents within 15 days prior to enrolment.

11.Concomitant use of psychotropic drugs.

12.History of alcohol consumption

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
GOS (Global over all symptoms) scaleTimepoint: 0th , 7th, 14th, 21st and 28th Day
Secondary Outcome Measures
NameTimeMethod
1.Changes in the clinical global impression (CGI) scale score22 <br/ ><br>2.Unani Medicine Symptom Score5 (SS) <br/ ><br>Timepoint: 0th , 7th, 14th, 21st and 28th Day
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