A Clinical trial to study the effect of Ayurvedic coded drug to prevent the side effects of Chemotherapy in Lung Cancer.
- Conditions
- Health Condition 1: null- Non Small Cell Lung Cancer stage III and IV.
- Registration Number
- CTRI/2011/12/002231
- Lead Sponsor
- Central Council For Research in Ayurveda Siddha under department of AYUSH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Age eligible for study18 years and older
Gender eligible for studyBoth
Accept healthy volunteersNo
Disease characteristicsHistological / Cytological confirmed Non Small Cell Lung Cancer Advanced stage III and IV with measurable lesions (Primary/ metastatic lesions) must be evaluable radio graphically.
Patient characteristicsOver 18 years of age.
Performance statusKornoffsky performance status >70%
Life expectancyat least 3 months after diagnosis
HepaticPlatelets > 100,000/mm3 S. Bilirubin < 1.5 mg/dl, SGOT and SGPT < 2 times normal
RenalS. Creatinine < 1.5 mg/dl
OtherNo concurrent active infection, NO prior malignancy. Not pregnant or nursing, effective contraception required for all female patients.
Non measurable disease
Known secondary Neoplasm
Active Central Nervous System metastasis
Hermatolymphoid cancers including acute or chronic leukemia, lymphoma or multiple myeloma
Pregnancy or Breastfeeding or adults of reproductive potential not employing effective birth control measures.
Concurrent severe or uncontrolled medical disease.
Acute or chronic liver disease
Confirmed diagnosis of HIV.
Insulin dependent diabetes mellitus /abnormal glucose tolerance test (GTT) latent diabetes mellitus type 1 or type
Surgery less than 4 weeks prior to entry or not recovered from effects of surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To assess the efficacy of â??Ayush QOL-2Câ?? in improvement in quality of life in advanced Non Small Cell Lung Cancer patients receiving Chemotherapy. <br/ ><br>2)To assess the safety of â??Ayush QOL-2Câ??Timepoint: 128 days
- Secondary Outcome Measures
Name Time Method 1)To assess the effect of â??Ayush QOL-2Câ?? on overall survival. <br/ ><br>2)To assess the effect of â??Ayush QOL-2Câ?? on event free survival. <br/ ><br>3)To assess the effect of â??Ayush QOL-2Câ?? on Progression free survival. <br/ ><br>Timepoint: nil