| CTRI Number |
CTRI/2025/12/099708 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
can turmeric mouthwash prevent and reduce the oral mucositis in patients admitting for bone marrow transplant |
|
Scientific Title of Study
|
Effectiveness of Turmeric Mouthwash in Preventing and Reducing the Severity of Conditioning-Induced Oral Mucositis in Bone Marrow Transplant Patients: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Kumari khowal |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS DELHI |
| Address |
Room No. 925 private III 9th floor Main Hospital, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868203600 |
| Fax |
|
| Email |
nishakhowal94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Rathee |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS Delhi |
| Address |
Room No. 920 private III 9th floor Main Hospital, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9896729674 |
| Fax |
|
| Email |
anjaliratheee00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Rathee |
| Designation |
Nursing Officer |
| Affiliation |
AIIMS Delhi |
| Address |
Room No. 920 private III 9th floor Main Hospital, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9896729674 |
| Fax |
|
| Email |
anjaliratheee00@gmail.com |
|
|
Source of Monetary or Material Support
|
| All INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
Nisha kumari Khowal |
| Address |
Private III 9th floor AIIMS New Delhi pin 110029 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anjali Rathee |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
ROOM NO 920 Private ward III 9th floor
New Delhi
DELHI |
9896729674
anjaliratheee00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D618||Other specified aplastic anemias and other bone marrow failure syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Turmeric mouth wash |
admitted pateints over a period of one year will be advised for turmeric mouth wash with 5ml of readymade solution of prescribed turmeric mouth wash 4 times a day along with the routine care and will be observed for the mucositis related to stem cell transplant conditioning regimen |
| Comparator Agent |
Usual care only |
Admitted patinets over a period of one year will be advised for usual mouth care only using chlorhexidine mouth wash sodabicarb mouth wash to prevent the oral mucositis |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged equal to more than 6 years (children and adults) scheduled for autologous or allogeneic
stem cell transplantation.
Patients scheduled for myeloablative or reduced-intensity conditioning chemotherapy.
For adults (more than 18 years Ability to provide written informed consent.
For children (less than 18 years): Written informed consent from parent/guardian and assent
from the child (age-appropriate).
Capability to perform oral rinses independently or with caregiver assistance. |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to turmeric or curcumin.
Presence of severe pre-existing oral lesions unrelated to chemotherapy (except mild
gingivitis).
Patients unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of turmeric mouthwash on the incidence and grade of
conditioning-induced oral mucositis in patients undergoing bone marrow
transplantation. |
baseline and 1odays after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of oral mucositis between patients receiving turmeric
mouthwash with usual care and those receiving usual care alone.
To compare the maximum severity grade of oral mucositis between the turmeric
mouthwash group and the usual care group
To assess and compare pain intensity associated with oral mucositis.
To compare the duration of analgesic use for pain due to oral mucositis between the
two groups |
baseline and 1odays after intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral mucositis is a common and painful complication of bone marrow transplantation leading to difficulty in eating, risk of infection, prolonged hospitalization and higher treatment costs. Current preventive and management strategies, including basic oral care and pharmacological interventions, are often insufficient, costly, or not widely available. Curcumin, the active compound in turmeric, has shown anti-inflammatory, antioxidant, and antimicrobial effects, reducing the incidence, severity, and pain of oral mucositis in chemotherapy and radiotherapy patients. However, evidence in bone marrow transplant recipients is limited, and standardized protocols are lacking. Investigating Turmeric mouthwash as an adjunct to usual care could provide a safe, cost-effective, and culturally acceptable option to prevent or reduce oral mucositis in this high-risk population. |