A clinical trial to evaluate the quality of life with AYUSH QOL 2C in patients of Non metastatic breast cancer as an adjuvant to chemotherapy

A prospective, randomized, double blind, placebo controlled comparative trial to Evaluate quality of Life with Ayush QOL-2C in patients of Non-Metastatic Breast Cancer as a supplement to adjuvant Chemotherapy.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001247

Enrollment

Registered

2011-01-10

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

Health Condition 1: null- Female Non Metastatic Breast Cancer patients receiving Chemotherapy

Interventions

Intervention1: AYUSH QOL 2C(Coded Ayurvedic formulation): 2 capsules(500mg/cap)twice daily for 6 months,oral administration Control Intervention1: Placebo: 2 capsules(500mg/cap)twice daily for 6 month

Eligibility

Inclusion criteria

Inclusion criteria: Patients of breast cancer. Age eligibility for study : 18 years and older Gender eligible for study : Female Disease characteristics : Histologically confirmed Cancer breast Patient characteristics : Over 18 years, of age Performance status : ECOG grade up to 2 Life expectancy : At least 3 months Haematopoietic : WBC greater than 4000/mm3 Platelet count > 100,000 mm3 Hepatic : Bilirubin less than 1.5 mg/ dl SGOT & SGPT more than 2 times normal Renal : Creatinine less than 1.5 mg/ dl Other : No concurrent active infection. No prior malignancy. Not pregnant or nursing Effective contraception for all Prior : Biologic therapy: not specified Chemotherapy : no prior chemotherapy

Exclusion criteria

Exclusion criteria: Known secondary neoplasia or central nervous system metastases. Acute or chronic leukemias. Lymphoma or multiple myeloma. Body weight below 40 kg Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control measures Concurrent severe or uncontrolled medical disease. Acute or chronic liver disease. Confirmed diagnosis of HIV. Uncontrolled diabetes. Surgery less than 2 weeks prior to entry ( or not recovered from effects of surgery)

Design outcomes

Primary

Measure	Time frame
TO EVLUATE THE EFFICACY OF AYUSH QOL 2C in improving Quality of Life [QOL]in non metastatic breast cancer female patients receiving chemotherapyTimepoint: Every 21 days till patient receives 4 or 8 chemotherapy cycles & at 6th month, 9th month, & final follow up at one year.	—

Secondary

Measure	Time frame
TO MONITOR THE SAFETY OF AYUSH QOL 2C in FEMALE PATIENTS WITH non-metastatic BREAST CANCER AS AN ADJUVANT to CHEMOTHERAPYâ?? â??TO ASSESS THE IMPROVEMENT IN QUALITY OF LIFE OF BREAST CANCER PATIENTS SUFFERING FROM GRADE I ,II & III receiving CHEMOTHERAPY FOLLOWING ADMINISTRATION of AYUSH QOL 2C as supplement to chemotherapy at each chemotherapy cycle and at 6 months and one year AFTER THE TREATMENTâ?? Timepoint: Every 21 days till patient receives 4 or 8 chemotherapy cycles & at 6th month, 9th month, & final follow up at one year.	—

Measure

Time frame

TO MONITOR THE SAFETY OF AYUSH QOL 2C in FEMALE PATIENTS WITH non-metastatic BREAST CANCER AS AN ADJUVANT to CHEMOTHERAPYâ?? â??TO ASSESS THE IMPROVEMENT IN QUALITY OF LIFE OF BREAST CANCER PATIENTS SUFFERING FROM GRADE I ,II & III receiving CHEMOTHERAPY FOLLOWING ADMINISTRATION of AYUSH QOL 2C as supplement to chemotherapy at each chemotherapy cycle and at 6 months and one year AFTER THE TREATMENTâ?? Timepoint: Every 21 days till patient receives 4 or 8 chemotherapy cycles & at 6th month, 9th month, & final follow up at one year.

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Countries

India

Contacts

Public ContactDr Shridhar B N

St Johns medical College

reachsuraj@reddifmail.com08022065744

Outcome results

None listed

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