Health Condition 1: K30- Functional dyspepsia Health Condition 2: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Pudin hara Antacid Suspension: It consists of Godhuma & Shatavari. It was given to the subjects in the dosage of 2 teaspoonful (10 ml) twice daily
Control Intervention1: Digene Suspens
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria:-Functional (Non â??ulcer)Dyspepsia(NUD) 1 Subjects with 24% of dyspepsia as per the Hong Kong Index of Dyspepsia 2 Subjects with normal upper gastrointestinal endoscopy, absence of any clinical, or ultrasonographic evidence of organic disease that would account for the symptoms. 3 In the event of patient undergoing treatment for dyspepsia, washout period of 1 week was mandatory. 4 Willingness to sign informed consent and to come for regular follow- up examinations as & when required. Inclusion Criteria:- Gastrointestinal Esophageal Reflux disorder(GERD) 5 Subjects suffering from Reflux oesophagitis. 6 Subjects complaining for more than 25 percent of the time like heartburn, regurgitation, for at least 1 month. 7 Subjects with Grade o and Grade I of GERD symptoms. 8 Subjects with gastrointestinal endoscopy positive and negative evidence. 9 Willingness to sign informed consent and to come for regular follow- up examinations as & when required.
Exclusion criteria
Exclusion criteria: Exclusion Criteria:-Functional (Non â??ulcer)Dyspepsia(NUD 1 Subjects suffering from peptic and duodenal ulcers. 2 Family history of peptic ulcer disease or gastric malignancy. 3 Subjects suffering from Reflux oesophagitis. 4 Subjects with chronic NSAID and steroids ( > 1 month) use with or without evidence of an ulcer 5 Uncooperative Subjects or subjects not willing to sign Informed Consent or giving consent for study required procedure like endoscopy. 6 Subjects with clinically diagnosed serious medical illness (Diabetes, SLE, Rheumatoid Arthritis, Rheumatic Arthritis, Psoriatic Arthritis), surgical illness where compliance is difficult. 7 Subjects on any other medication for the treatment of acidity other than specified in the study. 8 Subjects not willing to follow up for the study visits. 9 Subjects with age range below 16 years and above 65 years; dyspepsia persisting for less than 1 month before endoscopy; 10 Clinical evidence of irritable bowel syndrome; prior gastric surgery or proven peptic ulceration in the past; 11 Subjects with history of upper G.I. bleeding; 12 Subjects with overwhelming physical or mental disease (this includes subjects with carcinoma, pancreatitis, gall bladder disease, acute and chronic liver disease, bowel obstruction, chronic diarrhea and major psychosis); Exclusion Criteria:- Gastrointestinal Esophageal Reflux disorder(GERD) 13 Family history of peptic ulcer disease or gastric malignancy. 14 Subjects not giving consent for study required procedure like endoscopy. 15 Subjects with chronic NSAID use ( > 1month) with or without evidence of an ulcer. 16 Subjects not willing to sign Informed Consent. 17 Subjects with clinically diagnosed serious medical illness (Diabetes, SLE, Rheumatoid Arthritis, Rheumatic Arthritis, Psoriatic Arthritis), surgical illness where compliance is difficult. 18 Subjects on any other medication for the treatment of acidity other than specified in the study. 19 Subjects not willing to follow up for the study visits. 20 Patients meeting the above inclusion and exclusion criteria were made fully aware of the type of treatment given to them and then informed consent were taken.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any improvement or relief from clinical symptoms related to acidity at the end of 2 weeks and 4 weeks or by the resolution of symptoms whichever stands early.Timepoint: 2 weeks and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Any improvement or relief from clinical symptoms related to acidity at the end of 2 weeks and 4 weeks or by the resolution of symptoms whichever stands early.Timepoint: 2 weeks and 4 weeks | — |
Countries
India
Contacts
Public ContactDr J L N Sastry
Pragati Sparsh Ayurvedic Centre
Outcome results
None listed