A clinical trial to study the effects of Ayurvedic formulation containing Ashwagandha and Guduchi in improving the quality of life in patients of breast cancer receiving chemotherapy as treatment

A Proof of Concept prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of PHP- Cancer in improving quality of life in patients receiving chemotherapy for treatment of breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000052

Enrollment

Registered

2008-04-30

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: Tablet PHP-Cancer containing hydro-alcoholic extracts of Withania somnifera 150mg and Tinospora cordifolia 200 mg: 500 mg BD for 6 months Control Intervention1: Tablet Placebo: 500 mg B

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients in age group of 18 to 60 years (irrespective of menopausal status) with a life expectancy of at least 6 months 2. Patients with breast cancer scheduled to receive chemotherapy 3. Patients ready to consent and to abide by trial related procedures

Exclusion criteria

Exclusion criteria: 1. Patients likely to receive radiation therapy; alone or in combination with chemotherapy during the study period 2. Patients scheduled to receive palliative chemotherapy 3. Patients with mental condition that would interfere with completion of questionnaires 4. Patients receiving prophylactic G-CSF therapy 5. History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies for the last one month. 6. Liver, kidney and/or bone marrow disorders 7. Acute medical/surgical complications which require hospitalization

Design outcomes

Primary

Measure	Time frame
The primary outcome measures will be 20% improvement in the QOL score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.Timepoint:	—

Secondary

Measure	Time frame
Not ApplicableTimepoint:	—

Countries

India

Contacts

Public ContactDr. Shilpa Gaikwad

Professor & Head, Dept. of Clinical Pharmacology

urmilathatte@gmail.com022-23014713, 23050347

Outcome results