Skip to content

A clinical trialon effectiveness of Ayurvedic medicines in improving the disease free survival and/or controlling recurrence of disease of breast cancer patients, who are carriers of BRCA 1/2 genes using complimentary Ayurvedic treatment.

A Randomized parallel group trial on a cohort on effectiveness of Ayurvedic treatment modalities in improving the disease free survival in carriers of BRCA 1/2 genes inbreast and ovarian cancer patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007684
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 and ovarian cancer patients carriers of BRCA ½ genes. Problem studied â??Early metastasis and rapid growth of cancer due to inherited susceptibility genes Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: A. Suvarna Bhasmadi Vati: Study group patients (1) would have completed their surgery and are on chemotherapy or have completed chemotherapy will start the intervention with following A

Sponsors

Dr S P Sardeshmukh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Genetically predisposed patients (BRCA1/2 mutation carriers) with breast or ovarian cancer within 6 months to 1 year of diagnosis. During this period they would have completed conventional cancer treatment.Patients with stage I to IV of disease will be included

Exclusion criteria

Exclusion criteria: Patients with BRCA1/2 mutation reporting 1 year and more after diagnosis will be excluded

Design outcomes

Primary

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

Secondary

MeasureTime frame
Blood SugarTimepoint: Day 0 ( before starting Ayurvedic treatment);Changes in HeamogramTimepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines;Changes in Immune parameters (cytokines) like IL 1, IL- 6, IL-8, IL -10, IFN Gamma, TNF AlphaTimepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines;Changes in Kidney Function TestTimepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines;Changes in Liver Function TestTimepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines;Changes in Oxidative Stress by Catalase, SOD, GST and GSTP1 Hypermethylation Timepoint: Day 0 (Before starting Ayurvedic medicines), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras 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), After 1 year of Ayurvedic medicines, After 2years of Ayurvediic medicines, After 3 yeras of Ayurvedic medicines

Countries

India

Contacts

Public ContactDr Pradnya Chaugule

Integrated Cancer Treatment and Research Centre

kulkarniswapna@ymail.com02067346124

Outcome results

None listed

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