Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
None listed
Sponsors
Institute of Teaching and Research in Ayurveda Jamnagar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Individuals of either gender, aged between 18 and 60 years. 2.Participants must meet the Rome IV criteria for Functional Dyspepsia. 3.The participants should have one or more symptoms of functional dyspepsia, and no evidence of structural diseases. 4.Participants must be capable of providing written informed consent to take part in the study.
Exclusion criteria
Exclusion criteria: 1.Individuals who have gastro-oesophageal reflux disease, Symptomatic gallstone disease, sphincter of Oddi dysfunction, biliary dyskinesia, or gallbladder cancer, peptic ulcer disease, crohn s disease, gastro-oesophageal malignancy, gastroparesis, hepatocellular carcinoma, chronic pancreatitis, or pancreatic cancer, Chronic mesenteric ischaemia. 2.The participants with ongoing drugs (eg, non-steroidal anti-inflammatory drugs, iron, calcium antagonists, angiotensin-converting enzyme inhibitors, methylxanthines, glucocorticoids, antibiotics [eg, tetracyclines or erythromycin] 3.History of significant gastrointestinal conditions, such as gastric bleeding, intestinal obstruction, perforation, or having undergone GI surgery. 4.The participants with cognitive impairments, which could hinder the response to questionnaires. 5.The participants with a history of addiction or abuse of medications or drugs, subjects who continued to abuse alcohol over time (alcoholics), smokers or ex-smokers who had quit less than a year prior, celiacs, and subjects with eating disorders. 6.The participants with heart disease, chronic hepatic, biliary, and pancreatic pathologies, neoplastic pathologies, genetic-metabolic diseases. 7.Systolic blood pressure above 160 mmHg or diastolic blood pressure above 90 mmHg (confirmed by repeated measurement), within 2 weeks before randomization. 8.A known case of positive Human immunodeficiency virus/Hepatitis B surface antigen/anti-hepatitis C virus antibody. 9.If the patient has a known allergy to the investigation product or any of its ingredients. 10.Pregnant/breastfeeding female at screening or throughout the study period. 11.Vulnerable patients (as defined by ICMR guidelines).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Improvement in clinical symptoms by Short-Form Leeds Dyspepsia Questionnaire.(Mean change of score from baseline to 8 weeks)Timepoint: 1)Improvement in clinical symptoms by Short-Form Leeds Dyspepsia Questionnaire.(Mean change of score from baseline to 8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in classical symptoms of Ajirna (from baseline to 8 weeks). 2.Agnibala Assessment Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactAnukrati Vyas
Institute of Teaching and Research in Ayurveda Jamnagar
Outcome results
None listed