Health Condition 1: L651- Anagen effluvium Health Condition 2: null- Female Breast Cancer Patients under Chemotherapy
Conditions
Interventions
Intervention1: IND02 capsules: 400 mg, one capsule, thrice a day) during chemotherapy cycle 1 to 4
Control Intervention1: Placebo capsule: 400 mg, one capsule, thrice a day) during chemotherapy cycl
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Female patients between 18 years and 70 years of age. • Patients with histologically or cytologically confirmed primary carcinoma of the breast by using core biopsy, needle biopsy or fine-needle aspiration cytology. • Patients who have undergone mastectomy and with indications for Chemotherapy. • Patients with Leucocyte count more than 4000/mm³. • Patients with Platelet count more than 100,000/mm³. • Patients with Hemoglobin more than 10.0 g/dL. • Patients who are willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: • Patients who have received prior Chemotherapy or hormonal therapy for the treatment of breast cancer within the last 6 months. • Patients with existing Mucositis or oral and throat pain condition prior to starting Chemotherapy. • Patient who have already shaved the scalp hair before receiving Chemotherapy. • Patients known to have hypersensitivity to the study medication, its excipients, its analogs, or any of the components of herbs. • Patients diagnosed with active sero-positive Acquired Immunodeficiency Syndrome (AIDS) or Hepatitis B/C. • Pre-menopausal female patients who are pregnant, lactating or of child bearing potential and not on contraceptives. • Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments. • Patients with other severe diseases including abnormal cardiac conditions, hepatic or renal disorder, uncontrolled diabetes or other medical conditions that is likely to interfere with the study in the investigatorâ??s judgment. • Patients who have participated in other cancer trials in the past 30 days. • Patients who, in the investigatorâ??s clinical judgment, are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Grading of Mucositis i.e. Oral ulcers using WHO Oral Mucositis Assessment Scale 2. Grading for Nausea using NCI CTC V.04 for Chemotherapy Toxicity scale 3. Frequency and intensity of Vomiting and frequency and intensity of Diarrhea using NCI CTC V.04 for Chemotherapy Toxicity scaleTimepoint: At Baseline (day 0, Start of Chemotherapy) and at Visits (at end of each chemotherapy cycles 1 to 4 (Every 21 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Leucopenia, Alopecia/hair fall (hair density, %anagen, %teleogen) using Trichoscan, anaemia, cachexia (weight loss), gobal assessment of efficacy by physician and patient on the basis of 4 point scale i.e. Excellent, Very Good, Good and Poor.Timepoint: At Baseline and at Visits (end of each chemotherapy cycles 1 to cycle 4 (Every 21 days);Safety: Hematology, ECG, Vital signs, AE monitoring, Laboratory safety measurements (biochemistry, urine routine and ESR).Timepoint: At Baseline and at Visits (end of each chemotherapy cycles 1 to cycle 4 (Every 21 days) | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited
Outcome results
None listed