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A clinical trial on effectiveness of Ayurvedic medicines in improving the disease free survival and/or controlling recurrence of disease of breast cancer patients, whose cancer cells are negative for further hormonal treatment using complimentary Ayurvedic treatment.

A parallel group trial on a cohort on effectiveness of Ayurvedic medicines in improving the disease free survival in triple negative breast cancer patients treated with Ayurvedic treatment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007690
Enrollment
50
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 â??Breast cancer patients negative for triple receptors, Problem studied â??Early metastasis and rapid growth of cancer due to inability to respond to hormonal therapy. Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: SBD/MKD/ST/AT/JMO/CHEMOTHERAPY/PANCHAKARMA: Study group 1A Morning â?? Evening â?? Suvarnabhasmadi Yoga â?? 395 mg with cowâ??s milk, MauktikyuktaKamdudha â?? 500 mg, ShatavariVati â??

Sponsors

Dr Vasanti Godse
Lead Sponsor
Dr S P Sardeshmukh
Collaborator
Dr Shubhada Chiplunkar
Collaborator
Dr Sudha Gangal
Collaborator
Dr Tushar Patil
Collaborator
Dr Vineeta VDeshmukh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Immunohistochemically proved triple negative breast cancer patients of stages I to III, in the age group between 25 and 75 will be included in the study

Exclusion criteria

Exclusion criteria: Patients with distant metastasis at diagnosis (Stage IV) will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
For assessment of recurrence or metastasis, clinical examination, mammography, PET CT, CT scan (Abdomen and pelvis), 2 D echo, and other imaging techniquesTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 1.5 years of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 2.5 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines.—

Secondary

MeasureTime frame
Changes in Kidney Function TestTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in Liver Function TestTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in Oxidative stress by Catalase, SOD, GST and GSTP1 Hypermethylation Timepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Blood SugarTimepoint: Day 0 (Before Starting Ayurvedic treatment);Changes in C Reactive ProtienTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in HaemogramTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in Immune parameters (cytokines)like IL 1, IL- 6, IL-8, IL -10, IFN Gamma, TNF Alpha Timepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before Starting Ayurvedic Medicines), After 6 months of Ayurvedic medicines, After 1 year of Ayurvedic medicines, After 2 years of Ayurvedic medicines, After 3 years of Ayurvedic medicines;Changes in Quality of Life Questionnaires (QLQ C30 and BR23) of EORTC for Quality of LifeTimepoint: Day 0 (Before Starting Ayurvedic Medicines), Afte—

Countries

India

Contacts

Public ContactDr Anita Shingate

Integrated Cancer Treatment and Research Centre

shrinivasdatar@gmail.com02067346124

Outcome results

None listed

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