A clinical trial to study the effect of an ayurvedic treatment schedule in patients with breast cancer

Phase 1/2

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: CTRI/2018/02/012113
• Lead Sponsor: The Managing Trustee

Brief Summary

The study is an open clinical trial to study the effect of an ayurvedic treatment schedule on the protein profiles of breast cancer patients using High Performance Liquid Chromatography (HPLC-LIF ) and to compare the protein profiles of breast cancer patients and healthy volunteers using High Performance Liquid Chromatography- Laser Induced Fluorescence (HPLC-LIF). Two ml blood will be collected from each participant satisfying the eligibility criteria, before starting the treatment after getting the informed consent. The blood samples will be frozen and sent to the department of atomic and molecular physics, Manipal Institute of Technology for conducting the HPLC-LIF evaluation. The treatments are started for breast cancer patients as per the protocol. At the end of fourth and eighth week, blood samples are collected again and sent for evaluation. Two ml venous blood samples are collected from twenty healthy volunteers before the study and after eight weeks.The data obtained will be analyzed using appropriate statistical methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Newly diagnosed cases of breast cancer.

Exclusion Criteria

• 1.Undergoing treatment for any other cancers other than breast cancer 2.Breast cancer cases post surgery, post radiotherapy and chemotherapy 3.Breast cancer cases with auto immune diseases.
• 4.Breast cancer cases with any other systemic diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Protein profiles of blood sample	2 months
2. Early diagnosis	2 months

Secondary Outcome Measures

Name	Time	Method
1. Quality of life	2 months

Trial Locations

Locations (1)

Arya Vaidya Sala Charitable Hospital; 🇮🇳 Malappuram, KERALA, India

Arya Vaidya Sala Charitable Hospital

🇮🇳Malappuram, KERALA, India

Dr Ramesh PR

Principal investigator

04832808195

rameshvarier@aryavaidyasala.com