Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Malakudaara Mezhugu: Dosage :
1 Year- 200mg
2 Year- 400 mg
3 year- 500 mg
with milk in the night after food
Route of administration: Oral
Duration: 7 days
Control Intervention1: Nil: N
Sponsors
Ayothidoss Pandithar Hospital, Ayothidoss Pandithar Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Children with minimum two of the following clinical symptoms for atleast three month (Based on Rome IV criteria for Functional Constipation) 1) Straining during more than one-fourth (25%) of defecations 2) Lumpy or hard stools (Bristol Stool Form Scale 1 or 2) more than one-fourth (25%) of defecations 3) Sensation of incomplete evacuation more than one-fourth (25%) of defecations 4) Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations 5) Manual maneuvers to facilitate more than one-fourth (25%) of defecations (such as digital evacuation, or support of the pelvic floor) 6) Fewer than 3 Spontaneous Bowel Movements per week 7) Patient’s informant / Parent willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Intolerance to the drug and development of adverse reactions such as nausea, vomiting, abdominal discomfort during trial period. 2) Poor patient compliance & defaulters. 3) Patient turned unwilling to continue in the course of clinical trial. 4) Aggravation of symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome will be assessed using Bristol Stool Scale in children with Functional Constipation.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr A M Amala Hazel
National Institute of Siddha
Outcome results
None listed