A clinical trial on effectiveness of complimentary Ayurvedic treatment to increase cancer free life in healthy women carrying BRCA 1/2 gene, which is highly responsible for cancer of breast and ovary.

A non-randomized parallel group clinical trials on effectiveness of Ayurvedic treatment modalities in improving the cancer free survival in genetically predisposed healthy women carrying BRCA 1 / 2 mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011644

Enrollment

160

Registered

2018-01-31

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

None listed

Interventions

Intervention1: SBD/MKD/KK/PANCHAKARMA: Morning- Suvarnabhasmadi Yoga â?? 197.5 mg with cowâ??s ghee, MauktikyuktaKamadudha â?? 250 mg / with milk, Evening MauktikyuktaKamadudha â?? 250 mg / with milk

Eligibility

Inclusion criteria

Inclusion criteria: Genetically predisposed healthy women with BRCA1/2 mutation carriers within 6 months to 1 year of diagnosis not suffering from any type of cancer.

Exclusion criteria

Exclusion criteria: Healthy men who are BRCA 1/2 mutation carriers. Healthy carriers of BRCA 1/2 mutation who are already taking other Ayurvedic treatments.

Design outcomes

Primary

Measure	Time frame
For assessment of occurrence, clinical examination, , USG (abdomen and pelvis) Mammography and MRI breast Timepoint: â?¢ Clinical assessment and laboratory tests will be done at 3 months interval since enrollment in 1st year then 6 monthly in 2nd and 3rd year â?¢Radiological assessment will be done at specific time points.MRI breast-(baseline end of 1 year ,end of 3 years), Mammography (base line and end of 2 years), USG-Abdomen and Pelvis-(baseline,6 monthly, end of 1st year,end of 2nd year end of 3rd year). 3 sets of Panchakarma of 14 days yearly once will be given to study group patients.	—

Measure

Time frame

For assessment of occurrence, clinical examination, , USG (abdomen and pelvis) Mammography and MRI breast Timepoint: â?¢ Clinical assessment and laboratory tests will be done at 3 months interval since enrollment in 1st year then 6 monthly in 2nd and 3rd year â?¢Radiological assessment will be done at specific time points.MRI breast-(baseline end of 1 year ,end of 3 years), Mammography (base line and end of 2 years), USG-Abdomen and Pelvis-(baseline,6 monthly, end of 1st year,end of 2nd year end of 3rd year). 3 sets of Panchakarma of 14 days yearly once will be given to study group patients.

—

Secondary

Measure	Time frame
Blood sugarTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;CA 125Timepoint: Day 0-Baseline(Before starting Ayurvedic treatment),after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in heamogramTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in Immune parameters (cytokines) like IL-1,IL-6, IL-8,IL-10,IFN gamma, TNF alphaTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in karnofsky score-for performance statusTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in Kidney function testsTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic trea	—

Measure

Time frame

Blood sugarTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;CA 125Timepoint: Day 0-Baseline(Before starting Ayurvedic treatment),after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in heamogramTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in Immune parameters (cytokines) like IL-1,IL-6, IL-8,IL-10,IFN gamma, TNF alphaTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in karnofsky score-for performance statusTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), After 3 months of ayurvedic treatment,after 6 months of ayurvedic treatment,after 9 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic treatment,after 2 year of ayurvedic treatment,after 2.5 year of ayurvedic treatment,after 3 year of ayurvedic treatment.;Changes in Kidney function testsTimepoint: Day 0-Baseline(Before starting Ayurvedic treatment), after 6 months of ayurvedic treatment,after 1 year of ayurvedic treatment,after 1.5 year of ayurvedic trea

—

Countries

India

Contacts

Public ContactDr Pradnya Tilekar

Integrated Cancer Treatment and Research Centre

kulkarniswapna@ymail.com02224130866

Outcome results