Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic SciencesNew Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Subjects fulfilling the Rome IV criteria (2016) for FD.ie, Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis with one or more of the following symptoms: Upper abdominal pain (epigastric pain) or discomfort, Postprandial fullness, Early satiation, Bloating, Nausea, Belching. (3) No evidence of any organic disease (4) Patients not taking antidepressants, anxiolytics, or antipsychotics. (5) Patient is willing to participate and able to provide an informed consent
Exclusion criteria
Exclusion criteria: Participants taking antibiotics or nonsteroid anti-inflammatory drugs two weeks before the study. ii) Gastroesophageal reflux disease iii) Drug or alcohol abuse IV)The presence of gastroesophageal malignancy, chronic digestive diseases, and peptic ulcer disease based on history, physical examination, laboratory tests (e.g., white blood cell count, C reactive protein (CRP) or erythrocyte sedimentation rate (ESR) and upper endoscopy. V) Liver and kidney dysfunction based on laboratory tests. VI) Systemic disease (e.g., neurological disorders such as Parkinsonâ??s disease) and metabolic diseases (such as diabetes mellitus) VII) Pregnant and lactating women. VIII) The history of upper gastrointestinal tract surgery. IX) Illnesses like heart failure, epilepsy, and previous or current significant psychiatric co morbidity. X)Testing positive for H.Pylori during screening XI)Esopghagitis,Barrettâ??sesophagus,cancer,erosion and ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in functional dyspepsia symptoms assessed by Short Form Leeds Dyspepsia Questionnaire (SF-LDQ) Timepoint: baseline, 15th day,30th day,45th day, 60th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease relapse rate after treatmentTimepoint: 2 weeks from end of treatment period ie, on 75th day, based on the reappearance of clinical symptoms ;Assessment of QOL in FD patients by SF36,SF-NDITimepoint: baseline, -30th day 60th day ;Psychological assessment by Hamilton Anxiety Rating ScaleTimepoint: baseline, -30th day 60th day | — |
Countries
India
Contacts
Public ContactDR INDU S
Central Ayurveda Research Institute, Bhubaneswar, Bharatpur, Bhubaneswar
Outcome results
None listed