Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: Unani formmulation containing Sesamum indicum Linn.
Cheiranthus cheiri Linn.
Papaver somniferum
Linn.
: Test drug in Safoof (powder) form should be given in 10gm before breakfast with
Sponsors
Rajiv Gandhi University of Health Sciences
Eligibility
Inclusion criteria
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 Patients between 18 to 65 years of age of any gender Patients willing to take part in the study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in GerdQ Change in GOS Scale Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Unani medicine symptom score. 1. Hirqat-ul-Mida Symptom score 2. Waja-ul-Fawad symptom score Comparison of Side effects. Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Abdul Mobeen
National Institute Of Unani Medicine
Outcome results
None listed