Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Gasex DS tablets: Gasex DS one tablet twice daily for a period of 30 days orally.
Control Intervention1: not applicable: not applicable
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1 Either male and female subjects Aged 18 to 65 years 2 Women can be recruited if they meet either one of criteria They will be of non-child bearing potential If they are of child bearing potential to avoid conception they must be willing to adhere to natural family planning methods, which are accepted ethical according to institutional policy Men can be recruited if they are willing to adhere to natural family planning methods, which are accepted ethical according to institutional policy 3 Subjects diagnosed with any one of below Arm ARM a Subjects presenting with signs and symptoms of functional dyspepsia with one or more of the following a Bothersome postprandial fullness b Early satiation c Epigastric pain d Epigastric burning Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis OR ARM b Subjects diagnosed with gastroparesis presenting with one or more of the following Diabetic Non Diabetic Nausea retching vomiting early satiety post prandial fullness loss of appetite bloating stomach fullness or belly visibly larger. Subject on stable treatment for diabetes for the last 6 months OR ARM c Abdominal discomfort during post operative period The subject should be stable and with surgery gap of minimum of 7 days before dosing OR ARM d Abdominal discomfort during prolonged immobilisation limited mobilisation 4 Willing to sign inform consent document 5 No other drug intended to treat the study condition during study period
Exclusion criteria
Exclusion criteria: 1. Patients with significant systemic illness or disorder/ or any other gastro intestinal malignancy/bleeding disorder/Gastrectomy/ history of structural disease in upper GIT(Eg: Ulcer, surgery etc). 2. Subjects with established GERD (Gastroesophageal reflux disease) or IBS (Irritable bowel syndrome) or known H.Pylori infection 3. Patients with any severe uncontrolled psychological disorder, or any other significant terminal disease 4. Subjects with a strong history of food or drug allergy or hypersensitivity to any of the ingredients in the test products. 5. Women who are pregnant or nursing mothers. 6. Other conditions determined by the investigator to be inappropriate for this clinical study 7. Patients with a co-existing disease for which they have to take a concomitant medication such as: systemic corticosteroids, immuno-suppressants etc. 8. Patients with any serious disease that would interfere with the compliance to study protocol and proper completion of the trial 9. Patient with severe anemia, leucopenia or thrombocytopenia or any other clinically significant blood disorders 10. Patients with hepatitis/fibrosis, cirrhosis, or any other active hepatic disordersor any abnormal kidney functions 11. Patients with uncontrolled diabetes & hypertension 12. Patients who have received any other investigational drug within 4 weeks prior to screening. /Has participated in a similar clinical investigation in the past four weeks. 13. Patients with Alcohol or drug dependence/History of alcohol abuse, smoking, tobacco. 14. Serum SGPT > 3 X , Creatinine > 1.5 X the Upper Limit of Normal (ULN) of the reference range at the screening assessment 15. Patients with any screening laboratory values that deviate from upper or lower limits of the reference range, except for clinically insignificant deviations as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of Improvement from baseline to Day 30 in symptoms score Gastroparesis cardinal symptom index Symptom Evaluation and QOL.Timepoint: Visit 1 Screening Visit Visit 2 At entry visit Day 1 Visit 3 Day 15 ±3 days Visit 4 Day 30 ±3 days End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation through Incidence of adverse events during the study periodTimepoint: Day 1 Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Srikrishna
The Himalaya Drug Company
Outcome results
None listed