A clinical trial to assess the effectiveness of Ayurvedic drugs to reduce toxic effects of chemotherapy and improving Quality of Life of breast cancer patients

A parallel group trial on a cohort on effectiveness of Ayurvedic medicines in reducing adverse effects of chemotherapy, improving disease free survival and quality of life using assessment criteria such as CTCAE, Karnofsky score and QLQ by EORTC, and assessment of immune response and oxidative stress in breast cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/01/007687

Enrollment

120

Registered

2017-01-12

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- Health condition - Breast Cancer patients undergoing chemotherapy, Problem studied - Adverse effects of chemotherapy Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: Suvarna bhasmadi Yoga â?? 395 mg , morning evening, with cowâ??s ghee for 10 months, 2. MauktikyuktaKamadudha â?? 500 mg morning evening, with cowâ??s ghee for 10 months, 3. Padmakadi

Eligibility

Inclusion criteria

Inclusion criteria: Patients who have undergone surgery (either BCS or MRM) with stage I, II and III disease, who are eligible for chemotherapy and who have normal Haemogram, LFT, KFT and 2D Echo

Exclusion criteria

Exclusion criteria: Patients who are in stage IV, who are receiving Ayurvedic drugs for any other ailment and who have received chemotherapy earlier.

Design outcomes

Primary

Measure	Time frame
Adverse effects of chemotherapy as per Common Toxicity Criteria (CTC)Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo	—

Measure

Time frame

Adverse effects of chemotherapy as per Common Toxicity Criteria (CTC)Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo

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Secondary

Measure	Time frame
Blood SugarTimepoint: Day 0(Before 1 chemo);Changes in CA 15.3Timepoint: Day 0 (Before 1 chemo) , Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in HeamogramTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Immunological Markers Like IL-1, IL-6, IL-8, IL-10, IFN Gamma, TNF Alpha, CRPTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), , Day84 (Before 5 chemo), , Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Kidney Function TestTimepoint: Day 0 (Before 1 chemo) , Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 63 (Before 4 chemo), Day84 (Before 5 chemo), Day 105 (Before 6 chemo) , Day 135 (1 month after last	—

Measure

Time frame

Blood SugarTimepoint: Day 0(Before 1 chemo);Changes in CA 15.3Timepoint: Day 0 (Before 1 chemo) , Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in HeamogramTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Immunological Markers Like IL-1, IL-6, IL-8, IL-10, IFN Gamma, TNF Alpha, CRPTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), , Day84 (Before 5 chemo), , Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo;Changes in Kidney Function TestTimepoint: Day 0 (Before 1 chemo) , Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 63 (Before 4 chemo), Day84 (Before 5 chemo), Day 105 (Before 6 chemo) , Day 135 (1 month after last

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Countries

India

Contacts

Public ContactDr Pradnya Tilekar

Integrated Cancer Treatment and Research Centre

drnilambaripatil@gmail.com02067346124

Outcome results

None listed

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