A clinical trial to evaluate quality of life with AYUSH-QOL 2C in patients of Breast cancer on Chemotherapy/ Radiotherapy.

A pilot study evaluating Quality of Life with AYUSH-QOL 2C in patients of non-metastatic Breast cancer treated with adjuvant Chemotherapy/Radiotherapy and correlating it with molecular marker. Acronym : AYUSH-QOL 2C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000261

Enrollment

Registered

2010-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Ayush: AYUSH QOL / 2C 2 Caps (500 mg / cap ) b.d. with water Control Intervention1: chemotherapy: Cyclophosphamide 500mg / m2 i/v D1 Epirubicin 80 mg / m2 i/v D1 5 Fluoro Uracil 500 mg

Eligibility

Inclusion criteria

Inclusion criteria: Females less than 65 years with local non metastatic breast cancer in stage I to III not on any prior concurrent therapy. Hb > 10 gm/dl. TLC between 4000-11000 and having normal kidney and liver functions

Exclusion criteria

Exclusion criteria: Pregnant and lactating females. History of Uncontrolled diabetes mellitus, HIV positive patients. Patients with surger less than 2 weeks

Design outcomes

Primary

Measure	Time frame
Improvement in clinical status of patient. Quality of life. Co-relate with molecular markers ER, PR, HER2 neu Timepoint: 2years	—

Secondary

Measure	Time frame
The toxicity profile The loco-regional recurrence rate Timepoint: 2years	—

Countries

India

Contacts

Public ContactDr. RAAKHI MEHRA

pkjulka18@yahoo.co.in011 26594581

Outcome results