Health Condition 1: null- Cancer subjects with chemotherapy induced neutropenia
Conditions
Interventions
Intervention1: Immusante tablet: 2 tablets twice daily from the day of initiation till the completion of 3 cycles of the therapy / 3months
Control Intervention1: G-CSF: (SC)5mcg/kg daily from Day 1 to
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Both male and female patients aged more than 18 years Cancer patients except for blood cancer, receiving chemotherapy and or radiotherapy. Performance status Eastern Cooperative oncology Group (ECOG) Patient with a neutrophil count > 500 cell/cc Patients who were known to had Neutrophilia in the first cycle of chemotherapy of planned chemotherapy of four cycles. Patients who are planned with at least four more cycles of chemotherapy. Able to comply with the protocol and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with active uncontrolled infection Inadequate renal or hepatic function tests. Any evidence or history of hypersensitivity to herbal medicines. Recurrent/refractory/metastatic carcinomas Severe, life threatening complications associated with carcinoma Severe febrile neutropenia with neutrophil count of 500 cells/cc or below Not recovered from acute toxicities of the prior therapies. Not willing to sign the informed consent or abide by the study procedure. Pregnant or lactating women or women in the reproductive age group not willing to use an effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Neutrophil count, ECOG performance and clinical signs and symptoms.Timepoint: Improvement in Neutrophil count, ECOG performance and clinical signs and symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse eventsTimepoint: At baseline, Day 7, Day 14, Day 21 (and on additional intervals, if required) of every cycle for the period of the study | — |
Countries
India
Contacts
Public ContactDr padmanabha
the himalaya drug company
Outcome results
None listed