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A clinical trial to evaluate the improvement in quality of life of Stage 4 Non Small Cell Lung Cancer patients when treated with an Ayurveda intervention.

Phase 3
Conditions
Health Condition 1: C34- Malignant neoplasm of bronchus andlung
Registration Number
CTRI/2023/07/055912
Lead Sponsor
Ministry of Ayush
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients who are ready to provide written informed consent and willingness and ability to comply with study protocol.

2.Newly diagnosed patients of metastatic (Stage 4) Non-Small Cell Lung Cancer (NSCLC)with histological confirmation, as per tissue biopsy.

3.Age group 18 â?? 65 yrs irrespective of sex and religion.

4.Epidermal growth factor receptor (EGFR)mutation negative, on EGFR mutation analysis

5.Patients with PD-L1expression level <50%

6.PatientshavinganEasternCooperativeOncologyGroup(ECOG) performance score not higher than 2.

Exclusion Criteria

1.Patients with primary immunodeficiency and/or other causes of immunosuppression, including HIV or AIDS, autoimmune diseases, and other immunosuppressive disorders

2.Patients with known or active HIV or AIDS

3.Patients with known allergies or sensitivity to the study drug or components

4.Patients with current cardiovascular disease and/or risk factors, such as angina pectoris, uncontrolled hypertension, myocardial infarction, congestive heart failure, stroke, or cardiac arrhythmia or having a history of the same in past 6 months.

5.Patients with poorly controlled Hypertension ( >160/100 mm of Hg)

6.Pregnant or nursing women

7.Patients with other current malignancy

8.Patients with current or history of drug or substance abuse

9.Patients with psychiatric or mental illness

10.Any medical conditions that, in the opinion of the investigator would interfere with the outcome of the study.

11.Patients participating in any other interventional clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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