A Phase II Clinical Trial to Reduce the Chances of Severe Suppression of a type of white blood cells by Giving Sanjeevani Brown Rice with cancer Chemotherapy drugs like Taxanes or 5-Fluorouracil or Gemicitabine

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Sanjeevani Brown Rice Plus Chemotherapy: 30 gm Sanjeevani Rice Chocolate consists of 10 gm of rice Control Intervention1: Chemotherapy: All the drugs will be given in intravenous infusion and the dose will be given as per the recommended body surface area. CONDITION: Health Condition 1: C189‐ Malignant neoplasm of colon, unspecified Health Condition 2: C159‐ Malignant neoplasm of esophagus, unspecified Health Condition 3: C23‐ Malignant neoplasm of gallbladder Health Condition 4: C23‐ Malignant neoplasm of gallbladder Health Condition 5: C20‐ Malignant neoplasm of rectum Health Condition 6: C16‐ Malignant neoplasm of stomach PRIMARY OUTCOME: Incidence of grade 3 or 4 neutropenia Febrile neutropenia in patients taking 2 drug combination chemotherapyTimepoint: 8 to 12 Weeks SECONDARY OUTCOME: 1 Incidence of grade 3 or 4 neutropenia Febrile neutropenia in patients takin To reduce the requirement of GCSF during chemotherapy with the Sanjeevani Brown Rice ; 2 Incidence of febrile neutropenia in patients taking Sanjeevani Brown Rice along with chemotherapy ; 3 Acceptability & compliance of Sanjeevani Brown Rice consumption during the treatment period ; 4 Improve the quality of life of patients ; 5 Safety of Sanjeevani Brown Rice with the coadministration of chemotherapy drugsTimepoint: 8 to 12 Weeks INCLUSION CRITERIA: 1 Subjects between 18 years of age and provide a written informed consent 2 Subjects having oesophagal or Gastroesophageal junction GEJ squamous cell carcinoma gastricGEJ adenocarcinoma pancreatic cancer gall bladder cancer cholangiocarcinoma and colorectal cancers 3 Subjects who are chemotherapy nave and planned for initiation of chemotherapy regimen including 2 combination drugs history of previous surgeryradiotherapy can be considered 4 Subjects who have ECOG Eastern Cooperative Oncology Group performance status of 2 5 Chemotherapy in both metastatic and nonmetastatic settings will be considered 6 Acceptable bone marrow and organ function at screening as described below ANC 1500L without WBC growth factor support Platelet count 100000L without transfusion support Hemoglobin 8 gdL Transfusion is allowed to achieve this Hb Total Bilirubin 15 XULN Patients with known Gilberts s
Epistemonikos ID: 07641279303f3f797d1eefa8223711ef61506292
First added on: Oct 08, 2026