Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Individualized Homoeopathic medicine (IH) in Fifty Millesimal (LM) potency with Concomitant Care: Intervention is planned as giving Individualized Homeopathic (IH) medicine in LM potenc
Sponsors
The Calcutta Homoeopathic Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age of the patients to be included in study must be of paediatric age group from 4 to 17 years suffering from functional constipation (ICD-11 CODE- DD91.1). 2.Inclusion criteria will be followed strictly as per ROAM IV criteria for Child or Adolescents. 3.Diagnostic criteria- Must include two or more of the following occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of IBS i.e. i.Two or fewer defecations in the toilet per week in a child of a developmental age of at least 4 years. ii. At least one episode of faecal incontinence per week. iii. History of retentive posturing or excessive volitional stool retention. iv. History of painful or hard bowel movements. v. Presence of a large faecal mass in the rectum. vi. History of large diameter stools which can obstruct the toilet. vii. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition. 4.The parents providing written informed consent voluntarily and the children providing with informed assent.
Exclusion criteria
Exclusion criteria: 1.Age of the participants outside 4 to 17 years. 2.Patients diagnosed with IBS. 3.Structural GI abnormalities like Hirschsprung disease, Anorectal malformations, Significant prior abdominal surgery etc. 4.Neurological disorders affecting bowel motility like Cerebral palsy, Spinal cord anomalies or injury etc. 5.Metabolic or Endocrine conditions causing constipation like Hypothyroidism, Hypercalcemia, Diabetes with Neuropathy, untreated Celiac disease etc. 6.Use of Constipation inducing medications in the past 2 weeks like Opioids, Anticholinergics etc. 7.Active GI inflammation or infections like IBD, Infectious Colitis, Chronic Intestinal Pseudo-obstruction etc. 8.Alarming features suggesting any organic disease like Delayed Meconium, Severe Distension, Bilious Vomiting, Unexplained Rectal Bleeding, Failure to thrive, Severe Perianal Disease etc. 9.Patients participating in another simultaneous Interventional trial. 10.Patients under Medications for treatment of any chronic diseases. 11.The parents unwilling to provide written Informed Consent and the children with Informed Assent voluntarily. 12.Any condition deemed by the Investigator to make participation unsafe or confound results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Paediatric Functional Constipation Questionnaire-Parent Form (PedFCQUEST-PR)Timepoint: Baseline and Every Month up to 3 months of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| KIDScreen Health Questionnaire for Children (KIDScreen-10 HRQoL)Timepoint: Baseline and after 3 months of intervention;Modified Naranjo Criteria for Homeopathy (MONARCH) Causal Attribution InventoryTimepoint: At the end of the study;To Identify and Shortlist the most frequently indicated Individualized Homoeopathic medicine (IH) for functional constipation in the paediatric age groupTimepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr ANJAN ROY
The Calcutta Homoeopathic Medical College and Hospital
Outcome results
None listed