| CTRI Number |
CTRI/2025/03/082664 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the use of sivathai chooranam, a siddha medication in the treatment of constipation occurring due to opioid pain killers in cancer patients |
|
Scientific Title of Study
|
Using Sivathai Chooranam, a Siddha formulation in opioid induced constipation – A prospective, interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daniel Raj Joseph Thangasamy |
| Designation |
Palliative Care Physician |
| Affiliation |
Cancer Institute WIA |
| Address |
Room no 204, Department of Palliative Care, 2nd floor, IORT building, Dr. S. Krishnamurthi campus – 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9566997109 |
| Fax |
|
| Email |
dr.j.danny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Daniel Raj Joseph Thangasamy |
| Designation |
Palliative Care Physician |
| Affiliation |
Cancer Institute WIA |
| Address |
Room no 204, Department of Palliative Care, 2nd floor, IORT building, Dr. S. Krishnamurthi campus – 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9566997109 |
| Fax |
|
| Email |
dr.j.danny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Daniel Raj Joseph Thangasamy |
| Designation |
Palliative Care Physician |
| Affiliation |
Cancer Institute WIA |
| Address |
Room no 204, Department of Palliative Care, 2nd floor, IORT building, Dr. S. Krishnamurthi campus – 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9566997109 |
| Fax |
|
| Email |
dr.j.danny@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute WIA |
| National Institute of Siddha, Chennai |
|
|
Primary Sponsor
|
| Name |
Cancer Institute WIA |
| Address |
Dr. S. Krishnamurthi campus – 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Siddha |
The Director
National Institute of Siddha
(An Autonomous body under the Ministry of AYUSH)
Govt. of India.
Tambaram Sanatorium,
Chennai – 600 047 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Daniel Raj Joseph Thangasamy |
Cancer Institute WIA |
Room no 204, Department of Palliative Care, 2nd floor, IORT building, Dr. S. Krishnamurthi campus,
No 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
Chennai
TAMIL NADU |
9566997109
dr.j.danny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Cancer Institute WIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
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 with other medications for their cancer/ disease related symptoms. If there is constipation for more than 2 consecutive days (48 hours), then the dosage of Sivathai chooranam will be increased to 2grams BD. If there is constipation for more than 4 days ( 96 hours), then that is considered as failure and appropriate measures to relieve constipation will be administered based on physicians discretion. In patients who are not constipated and are not experiencing any adverse effects, they will be continuing on sivathai chooranam as long as they are receiving morphine. Proportion of patients constipated at the end of 48 hours and 96 hours based on Rome IV criteria. Number of times laxatives needed in every week for 12 weeks, consistency of stools based on Bristol stool form scale at the beginning, 48 hours, 96 hours, and at week 1, 4 and 12 will be noted. Change in average Bowel Function Index(BFI) score at the beginning, 48 hours, 96 hours, and at week 1, 4 and 12, average dose of sivathai chooranam required, patient reported side effects will be noted and reported. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients constipated at the end of 48 hours and 96 hours based on Rome IV criteria |
48 hours and 96 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient reported side effects of sivathai chooranam |
12 weeks |
| Average dose of sivathai chooranam required |
12 weeks |
| Number of times laxatives needed |
Every week for 12 weeks |
| Consistency of stools based on Bristol stool form scale |
At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12 |
| Change in average Bowel Function Index(BFI) score |
At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.j.danny@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
1. Origin of the proposal - The Rome IV criteria (panel) defines opioid-induced constipation as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. Opioid induced constipation(OIC) is a common side effect which occurs in patients for whom opioids are used in the management of pain. The prevalence of OIC among cancer patients receiving opioids is between 74 – 87%. So it is mandatory to prescribe laxatives prophylactically while prescribing opioids. The standard prescription includes stimulant laxatives like bisacodyl or sodium picosulfate. 2. Definition of the problem - Sivathai chooranam is a siddha medicine, consisting of 11 natural ingredients is proven to be effective in the management of functional constipation. But the efficacy of the same in management of OIC has not been studied yet. It has both laxative and anti-diarrhoeal properties even though it has been prescribed only for management of constipation along with warm water. If proven effective this can be a cheaper and natural alternative to the current management of OIC and a more acceptable one given our cultural context. 3. Objective - To assess the safety and efficacy of sivathai chooranam in opioid induced constipation for cancer patients requiring opioid analgesics |