Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Individualized homoeopathic medicines in individualized dosage plus concomittant care: According to what is deemed appropriate for the case or condition, the intervention is designed to
Frequency: Individualized
Duration of therapy: 3 months
Control Intervention1: Identical-looking placebo plus concomittant care: A placebo that looks exactly like verum will be given to this arm. The quantity and frequency of
Duration of therapy: 3 months
Sponsors
D. N. De Homoeopathic Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years 2. Participants of either sex or transgender 3. Diagnosed functional dyspepsia (ICD 11- DD90.3) as per ROME IV criteria. One or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) Bothersome postprandial fullness. b) Bothersome epigastric pain c) Bothersome early satiation d) Bothersome epigastric burning And, no evidence of structural disease (at upper GI endoscopy) that is likely to explain the symptoms. 4. Patients who are already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry. 5. Providing written informed consent 6. Patients with ability to understand English/Bengali/Hindi.
Exclusion criteria
Exclusion criteria: 1. Alarm symptoms of dyspepsia a)Unintentional weight loss b)Difficulty swallowing(dysphagia) c)Painful swallowing(odynophagia) d)Unexplained iron deficiency anemia e)Persisting vomiting f)Detectable mass or Lymphadenopathy g)Family history of upper gastrointestinal cancer 2. Recent significant GI surgery within last 6 months. 3. Patients who are too sick for consultation. 4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life. 5. Pregnancy, puerperium and lactation. 6. Substance abuse and/or dependence (TAPS TOOL) 7. Self-reported immune-compromised state, and 8. Undergoing homeopathic treatment for any chronic disease within last 3 months. 9. Unwilling to take part and not giving consent to join the study. 10. Simultaneous participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM)Timepoint: Baseline, and every month, up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Short Form Nepean dyspepsia index (SF-NDI)Timepoint: Baseline, and every month, up to 3 months;Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)Timepoint: Baseline, and every month, up to 3 months | — |
Countries
India
Contacts
Public ContactSanjib Sarkar
D. N. De Homoeopathic Medical College and Hospital
Outcome results
None listed