Effect of Ayurveda oral medicine as an add-on therapy in lung cancer

An Open-label,two-arm, Exploratory Randomised Controlled Trial to evaluate the effect of Vardhamana Pippali Rasayana as an add-on therapy in the management of Non-small cell lung cancer - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055417

Enrollment

Registered

2023-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of histologically proven lung malignancy (NSCLC of any subtype), willing to participate in the study 2. Patients with ECOG PS 0-III 3. Patients suffering from non-small cell lung cancer- Stage I to IV B and treatment naÃ¯ve at the time of screening 4. Age- 18-75 years of age 5. Gender- both male and female (non-pregnant, non-lactating) 6. Patients with no diagnosis of cancer within the past one year

Exclusion criteria

Exclusion criteria: - Patients not willing to take part in the study - Unable to take oral medications especially in the form of powder. - Patients of ECOG PS IV, V - Patients with active peptic ulcer, dyspepsia, or bleeding per rectum - Significant cardiovascular disease, such as myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina. -Inability to comply with other requirements of the protocol

Design outcomes

Primary

Measure	Time frame
-Objective Response Rate assessed through changes in the PET CT scan reports prior to & after intervention according to PET Response Criteria in Solid Tumors (PERCIST,Version 1.0). -Changes in the clinical symptoms of the patients before & after treatment using EORTC- LC13 questionnaire. Timepoint: WEEK-1 WEEK 4 WEEK8 WEEK 12 WEEK 16 WEEK 20 WEEK 24 WEEK 28	—

Secondary

Measure	Time frame
-Changes in the Quality of Life of the patients before & after treatment using EORTC-QLQ- C30 questionnaire. -Changes in the lung functions by means of Spirometry. -The safety profile of the intervention will be assessed by comparing -Hemogram, LFT & RFT parameters before & after intervention. -Number of participants with specified adverse event that is grade 2 or above & related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5) Timepoint: WEEK-1 WEEK 4 WEEK8 WEEK 12 WEEK 16 WEEK 20 WEEK 24 WEEK 28	—

Measure

Time frame

-Changes in the Quality of Life of the patients before & after treatment using EORTC-QLQ- C30 questionnaire. -Changes in the lung functions by means of Spirometry. -The safety profile of the intervention will be assessed by comparing -Hemogram, LFT & RFT parameters before & after intervention. -Number of participants with specified adverse event that is grade 2 or above & related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5) Timepoint: WEEK-1 WEEK 4 WEEK8 WEEK 12 WEEK 16 WEEK 20 WEEK 24 WEEK 28

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Countries

India

Contacts

Public ContactDr Parvathy Venate

All India Institute of Ayurveda, New Delhi

drvghuddar@gmail.com9986697942

Outcome results