CTRI/2018/05/013927
Recruiting
Phase 4
A Comparative Clinical Study to Evaluate Efficacy and Safety of Immusante as in the Prevention and Treatment of Chemotherapy Induced Neutropenia
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Cancer subjects with chemotherapy induced neutropenia
- Sponsor
- The Himalaya Drug Company
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \<\= 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.
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.
Outcomes
Primary Outcomes
Not specified
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