Immusante tablets in management of Chemotherapy induced Neutropenia
- Conditions
- Health Condition 1: null- Cancer subjects with chemotherapy induced neutropenia
- Registration Number
- CTRI/2018/05/013927
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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) <= 2
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Neutrophil count, ECOG performance and clinical signs and symptoms.Timepoint: Improvement in Neutrophil count, ECOG performance and clinical signs and symptoms.
- Secondary Outcome Measures
Name Time Method 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