| CTRI Number |
CTRI/2025/05/086615 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Randomized Controlled Trial to study the role of ginger-root-extract-capsules for children, adolescents, and young adults receiving highly- emetogenic-chemotherapy |
|
Scientific Title of Study
|
Study to evaluate the antiemetic efficacy of ginger root extract capsules for children adolescents and young adults receiving highly emetogenic chemotherapy A Seamless Placebo controlled single centre combined Phase II and III Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 243, second floor, Dr. B.R.A.I.R.C.H., ansari nagar, new delhi, 110029
New Delhi DELHI 110029 India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 243, second floor, Dr. B.R.A.I.R.C.H., ansari nagar, new delhi, 110029
DELHI 110029 India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 243, second floor, Dr. B.R.A.I.R.C.H., ansari nagar, new delhi, 110029
DELHI 110029 India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Pharmaceutical drug required for conducting the trial is supplied by HIMALAYA WELLNESS COMPANY Makali Bengaluru 562 162 India |
|
|
Primary Sponsor
|
| Name |
HIMALAYA WELLNESS COMPANY |
| Address |
MAKALI BENGALURU 562 162 INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Sameer Bakhshi |
AIIMS New Delhi |
Room No. 243, second floor, Dr. B.R.A.I.R.C.H., ansari nagar, new delhi, 110029 New Delhi DELHI |
9958828763
sambakh@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
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 |
| Intervention |
Ginger-root-extract-capsules |
Dose arm 1: 15 to less than 40kg: 1gm per day oral single dose more than or equal to 40kg: 2gm/day single dose
Dose arm 2: 15 to less than 40kg: 2gm per day oral in 2 divided doses; more than or equal to 40kg: 4gm per day in 2 divided doses
Dose arm 3: 15 to less than 40kg: 3gm per day oral in 3 divided doses more than or equal to 40kg: 6gm per day oral in 3 divided doses
|
| Comparator Agent |
Placebo |
Oral placebo Capsule in same number as intervention |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
Body weight greater then equal to 15kg
Diagnosis of solid or hematological malignancy scheduled to receive any cycle of a highly emetogenic chemotherapy regimen |
|
| ExclusionCriteria |
| Details |
CNS neoplasm primary or secondary (except vertebral or skull metastasis as long as they are not
breaching dura or compressing brain/spinal cord parenchyma)
Vomiting or retching within 24 hours before receipt of chemotherapy
Use of systemic steroids for malignancy or other uncontrolled systemic disease
Severe organ damage based on laboratory investigation within 2 weeks at the time of screening
Hepatic transaminitis greater then equal to 5 times upper limit normal and or serum bilirubin greater then equal to 3 times
upper limit normal of reference laboratory
Renal serum creatinine greater then equal to 1.5 times upper limit normal of reference laboratory
Any clinical evidence of heart failure
Uncontrolled bleeding manifestation known coagulopathy and patients on anticoagulation therapy Receipt of radiation to abdomen cranium or pelvis (within 1 week) Not able to read Hindi or English
Not able to swallow capsules
Refusal to provide consent |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase II study: To identify the best dose of ginger-root-extract-capsules for the phase III trial based on a decrease in chemotherapy-induced nausea (mean PeNAT scale score) for children, adolescents, and young adults (6 to 21 years) receiving HEC as compared to placebo.
Phase III study: To examine the efficacy of the best dose of the ginger-root-extract-capsules identified in the phase II trial on the incidence of complete remission (CR) in chemotherapy-induced vomiting (CIV) in the acute phase compared to placebo among children, adolescents, and young adults receiving HEC. |
Phase II study: 21 days for each participant
Phase III study: 21 days for each participant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.Incidence of CR in CIV in delayed and overall phase
b.The severity of chemotherapy-induced nausea (by PeNAT score) in both arms
c.Incidence of adverse effects in both arms |
21 days for each participant |
|
|
Target Sample Size
|
Total Sample Size="538" Sample Size from India="538"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Chemotherapy-induced nausea and vomiting (CINV) affects 40–70% of pediatric patients—over twice the risk seen in adults—despite antiemetic prophylaxis, which can reduce treatment adherence and increase hospitalization costs. Current guidelines recommend 5-HT3 receptor antagonists and dexamethasone for acute CINV in children, but research on pediatric cases remains limited, and no standard guidelines exist for delayed CINV. This highlights the need for additional or alternative treatments to manage CINV in children, adolescents, and young adults effectively. In a double-blind placebo-controlled trial, we have previously demonstrated that ginger-root-extract-capsules improve nausea and vomiting for children receiving cisplatin-containing chemotherapy. Several trials have demonstrated the efficacy of ginger in preventing CINV in adults. However, the proper dose and standardization of formulation are not yet well explored, and there is a lack of enough evidence to suggest statistically significant benefits in children, adolescents, and young adults.
There is a notable lack of research and well-conducted clinical trials on effective interventions for managing CINV in pediatric oncology. This study aims to bridge this gap by investigating the use of ginger capsules to alleviate nausea and vomiting in children, adolescents, and young adults receiving highly emetogenic chemotherapy. As a widely available, safe, and well- tolerated natural remedy, ginger offers a good option. This trial seeks to evaluate its efficacy in preventing CINV in children, adolescents, and young adults, adolescents, and young adults. If proven effective, ginger-root-extract-capsules could become a cost-effective, accessible, and practical option for managing CINV. |