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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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