clinical trial to assess effect of ayurveda treatments in hand-foot skin reaction which occurs as a side-effect in patients taking chemotherapy

AN OPEN LABEL CONTROL CLINICAL TRIAL TO ASSESS THE EFFECT OF AN AYURVEDA TREATMENT PROTOCOL CONTAINING PARISHEKA WITH YASHTIMADHU KASHAYA AND LEPANA WITH SHATADHAUTA GHRITA AS ADD ON THERAPY FOR HAND-FOOT SKIN REACTION IN CHEMOTHERAPY SUBJECTS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/040929

Enrollment

Registered

2022-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L271- Localized skin eruption due to drugs and medicaments taken internally

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Malignant tumour diagnosed by evidence of pathological or cytological findings An Eastern Cooperative Oncology Group performance status Treatment with Multi Kinase Inhibitors and occurrence of hand-foot skin reaction of any grade. Life expectancy >3 months. Those who are willing to participate in this study and sign informed consent forms.

Exclusion criteria

Exclusion criteria: Dermatological toxicities not induced by Multi Kinase Inhibitors. Concurrent acne vulgaris, eczema, psoriasis and other skin diseases. Abnormal cognition and speech causing difficulty in comprehension, expression and informed consent.

Design outcomes

Primary

Measure	Time frame
Change in the grade of HFSR based on CTCAE v5.0Timepoint: Before intervention : day 0 After intervention : day 31	—

Secondary

Measure	Time frame
1. Change in severity of pain according to VAS scale 2. Change in quality of life according to HFQoL questionnaire.Timepoint: Before intervention : day 0 After intervention : day 31	—

Countries

India

Contacts

Public ContactDr James Chacko

Amrita School of Ayurveda

ammassankar@gmail.com9447498812

Outcome results