Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Individualised Homoeopathic Medicine: Homoeopathic Medicine above 30 th potency mentioned in HPI will be administered orally according to the principles of Homoeopathy
for 3months
Cont
Sponsors
S Amrutha
Eligibility
Inclusion criteria
Inclusion criteria: 1) Cases satisfying ROME 4 diagnostic criteria. a)Must include one month of at least two of the following in infants up to 4 years of age:14 1. Two or fewer defecations per week 2. History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large diameter stools 5. Presence of a large fecal mass in the rectum In toilet trained children, the following additional criteria may be used: 6. At least one episode/week of incontinence after the acquisition of toileting skills 7. History of large diameter stools which may obstruct the toilet b) Rome 4 Diagnostic criteria for functional constipation: Must include one month of at least two of the following in children and adolescents:14 1. Two or fewer defecations in the toilet per week in a child of a developmental age of at least 4 years 2. At least one episode of fecal incontinence per week 3. History of retentive posturing or excessive volitional stool retention 4. History of painful or hard bowel movements 5. Presence of a large fecal mass in the rectum 6. History of large diameter stools which can obstruct the toilet 7. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition. 8. Patients in the age group of 0 to 6years of age. (Including 6 years)
Exclusion criteria
Exclusion criteria: 1. Patients using any medications that could cause constipation. 2. Patients having any previous diagnosis /symptoms suggestive of serious gastrointestinal diseases. 3. Major psychiatric disorders. 4.Cases with red flag signs pertaining to organic causes. 5.Significant chronic health conditions requiring speciality care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To determine the effect of homoeopathic medicines in improving PBMST scores in children with functional constipation up to 6years of age. 2)To determine the effect of homoeopathic medicines in improving defecation frequency in children with functional constipation up to 6years of age. Timepoint: PBMST score will be calculated at the baseline and 3months after individualized homoeopathic medicine has been taken. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Treatment success is defined as not fulfilling Rome 4 criteria for functional constipation during 3 of the last 4 weeks of trial, including the last week according to The Rome foundation paediatric subcommittee on clinical trials.Timepoint: 6 weeks;1)Treatment success is defined as not fulfilling Rome 4 criteria for functional constipation during 3 of the last 4 weeks of trial, including the last week according to The Rome foundation paediatric subcommittee on clinical trials.Timepoint: Baseline | — |
Countries
India
Contacts
Public ContactS Amrutha
Kerala University of Health Sciences
Outcome results
None listed