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Exploring the use of sivathai chooranam, a siddha medication in the treatment of constipation occurring due to opioid pain killers in cancer patients

Using Sivathai Chooranam, a Siddha formulation in opioid induced constipation A prospective, interventional study - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082664
Enrollment
20
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Sivathai Chooranam: Patients consenting for the study will be evaluated, and eligible patients will receive sivathai chooranam 2 grams/day mixed with honey or water, at bedtime along wi

Sponsors

Cancer Institute WIA
Lead Sponsor
National Institute of Siddha
Collaborator

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

MeasureTime 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

MeasureTime 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

Public ContactDaniel Raj Joseph Thangasamy

Cancer Institute WIA

dr.j.danny@gmail.com9566997109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026