Evaluation of Balamruta Rasayana As Supportive theapy in Cancer treatment (Chemo-radiation) induced side effects

Not Applicable

• Conditions: Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified

• Registration Number: CTRI/2022/02/040518
• Lead Sponsor: Dr Harish Babu H

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects of Either Sex age between 23yr-75yr.

2. Subjects suffering from Adenocarcinoma of Lungs, Stomach, Oesophagus, Prostate &

Intestine diagnosed with Biopsy.

3.Subjects undergoing Radiation and chemotherapy for above cancer presenting with Side effects.

4.Patients who are presenting adverse effects during/after chemo/radiation.

5.Subject provides written informed consent and gives authorization for use and disclosure of protected health information.

6. Subject agrees not to participate in other clinical trial.

Exclusion Criteria

Patients having Adenocarcinoma in more than 3 organs.

• Patients undergoing major surgery or H/o Surgery within 3 months.

• Patients having adenocarcinoma (Primary) in oral, Breast and brain.

• Patients having secondary metastatic Adenocarcinoma in Oral, brain or brain tissue.

• Subject has any Genetic diseases(Neurofibromatosis, Haemochromatosis etc)

• Subjects SPO2 less than 80

• Subjects having Adenocarcinoma with multi organ failure

• Subjects requiring dialysis

• Subjects serum is positive for HIV-1 or HIV 2 antibody

• Serum positive for Hepatitis B Surface antigen & Hepatitis.

• Subject has any underlying or current medical condition, which, in the opinion of the

Investigator, would interfere with the evaluation of the subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life assessed with EORTC-QLQ 30), ECOG or <br/ ><br>appropriate Questionnaires and amelioration of signs and symptomsTimepoint: Baseline, 3weeks, 6weeks

Secondary Outcome Measures

Name	Time	Method
Safety profile [Complete blood Count, Serum Creatinine, Serum Urea, SGOT, SGPT, <br/ ><br>ALP and Total Bilirubin, Total protein] <br/ ><br>CTCAE Version 5 QuestionnaireTimepoint: Before and After completion