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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

Phase 2
Registration Number
CTRI/2008/091/000052
Lead Sponsor
Council of Scientific & Industrial Research, New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
60
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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