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

Evaluation of Balamruta Rasayana as Adjuvant therapy in Chemoradiation(CRT)induced Adverse effects in Adenocarcinoma in Palliative care-A Randomised open labelled clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040518
Enrollment
140
Registered
2022-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

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

Interventions

None listed

Sponsors

Dr Harish Babu H
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Quality of life assessed with EORTC-QLQ 30), ECOG or appropriate Questionnaires and amelioration of signs and symptomsTimepoint: Baseline, 3weeks, 6weeks

Secondary

MeasureTime frame
Safety profile [Complete blood Count, Serum Creatinine, Serum Urea, SGOT, SGPT, ALP and Total Bilirubin, Total protein] CTCAE Version 5 QuestionnaireTimepoint: Before and After completion

Countries

India

Contacts

Public ContactDr Harish Babu H

Parul Institute of Ayurveda

gundappa.rao86220@paruluniversity.ac.in9866871077

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026