Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient fulfilling case definition 2.Patient in the age group of 8-18 years 3.Patient with worst pain score of at least 30mm on a 100mm visual analogue scale at baseline (pain during the 1-week run-in period was measured on a 100 mm Visual Analogue Scale at the end or if no pain was experienced during the run-in period, the worst pain experienced during the two weeks period prior to the start of the run-in period will be used)
Exclusion criteria
Exclusion criteria: 1.Patient with alarm features Family history of inflammatory bowel disease, celiac disease, or peptic ulcer disease, Dysphagia Odynophagia Persistent vomiting Gastrointestinal blood loss Persistent nocturnal diarrhea Arthritis Perirectal disease Involuntary weight loss Deceleration of linear growth Delayed puberty Unexplained fever 2.Patient with organic disease as the cause of abdominal pain and other concomitant gastrointestinal disorders 3.Patient with history of receiving probiotics in the preceding 1 month 4.Mental disability or psychiatric causes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Wong-Baker FACES pain rating scale score 2.Quality of life is assessed by using Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core scale Malayalam versionTimepoint: 1.Measured at baseline and at the end of 12 weeks 2.Measured at baseline (0 month) and at the end of treatment (3rd month). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Difference in intensity of pain measured by Wong-Baker FACES pain rating scale 2.Frequency of pain measured by pain diary 3.Percentage of responders (participants with at least 30% reduction in pain intensity measured on a 100mm Visual Analogue Scale) 4.Percentage of participants with adverse eventsTimepoint: 1.Measured every 4 weeks till end of study 2.Measured at baseline and at the end of 12 weeks 3.Measured at end of 12 weeks 4.Measured during the course of study | — |
Countries
India
Contacts
Government Homoeopathic Medical College Kozhikode