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Efficacy of Unani formulation in stomach reflux disorder

Phase 2
Conditions
Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Registration Number
CTRI/2022/03/041538
Lead Sponsor
Rajiv Gandhi University of Health Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

Subjects of uncomplicated symptomatic GERD in accordance with the Montreal definition

GerdQ score of 8 or more

Patients with symptomatic GERD with heartburn >=2 times weekly for the past 2 months

BMI < 40 kg/m2

Patients between 18 to 65 years of age of any gender

Patients willing to take part in the study

Exclusion Criteria

Patients with alarming symptoms like unintentional weight loss, recurrent vomiting, dysphasia, odynophagia, gastrointestinal bleeding, malena and anemia.

History of any serious gastrointestinal disease including peptic ulcer malignancy and dysmotility

Previous endoscopic diagnosis of erosive gastroesophagitis or Barretts esophagus.

Prior gastric or esophageal surgery for the treatment of GERD

Pregnant and lactating females

Patients of Systemic illness like cancer, epilepsy, kidney, cardiac and pulmonary diseases.

Patients who had used more than 3 doses of histamine-2 receptor antagonists or PPI within the week before randomization

Patients who had participated in an investigational drug or investigational device study within 30 days prior to the baseline visit

Patients who fail to give consent for the trial and follow up

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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