Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 - Confirmed diagnosis of cancer and prescribed morphine for the management of pain for the first time 2 - Patients who can take medications orally or through feeding tubes(NG tube/ NJ tube/ PEG) 3 - Australia - modified Karnofsky Performance Status more than or equal to 40 4 - Patients with normal cognitive function
Exclusion criteria
Exclusion criteria: 1 - Patients who are already having chronic constipation (Type 1 and 2 based on Bristol stool form scale) and receiving laxatives for the same 2 - Patients who are currently having diarrhoea or stool consistency Type 6 and 7 based on Bristol stool form scale 3 - Patients having Diabetes Mellitus and undergoing treatment for the same 4 - Patients with impaired liver function or liver failure 5 - Patients having acute or unstable liver injury/damage 6 - Patients having medical renal disease / renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients constipated at the end of 48 hours and 96 hours based on Rome IV criteriaTimepoint: 48 hours and 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported side effects of sivathai chooranamTimepoint: 12 weeks;Average dose of sivathai chooranam requiredTimepoint: 12 weeks;Number of times laxatives neededTimepoint: Every week for 12 weeks;Consistency of stools based on Bristol stool form scaleTimepoint: At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12;Change in average Bowel Function Index(BFI) scoreTimepoint: At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12 | — |
Countries
India
Contacts
Cancer Institute WIA