A Randomized Controlled Trial to study the role of ginger-root-extract-capsules for children, adolescents, and young adults receiving highly- emetogenic-chemotherapy

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086615

Enrollment

538

Registered

2025-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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: 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 d

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 Contr

Eligibility

Inclusion criteria

Inclusion criteria: Body weight greater then equal to 15kg Diagnosis of solid or hematological malignancy scheduled to receive any cycle of a highly emetogenic chemotherapy regimen

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Phase II study: 21 days for each participant Phase III study: 21 days for each participant	—

Measure

Time frame

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.Timepoint: Phase II study: 21 days for each participant Phase III study: 21 days for each participant

—

Secondary

Measure	Time frame
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 armsTimepoint: 21 days for each participant	—

Countries

India

Contacts

Public ContactSameer Bakhshi

AIIMS New Delhi

sambakh@hotmail.com9958828763

Outcome results

None listed

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