A study to compare efficacy of Abhyanga with Mahanarayana taila as an add on to the standard of care versus standard of care alone in chemotherapy induced peripheral neuropathy

Abhyanga with Mahanarayana taila as an add on to the standard of care in chemotherapy induced peripheral neuropathy: a non-randomized clinical control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059688

Enrollment

Registered

2023-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: G620- Drug-induced polyneuropathy

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Neuropathy attributed to chemotherapeutic agents with no prior history of attributable cause for chemotherapy induced peripheral neuropathy. 2)Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 3. 3)Self-reported neuropathy score greater than or equal to 3 on 0-10 scale and/or grade 2 or 3 neuropathy according to NCI-CTCAEv5 criteria. 4)Life expectancy more than 3 months. 5)Those who are willing to participate in this study and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1)Peripheral neuropathy other than those induced by neurotoxic chemotherapeutic agents. 2)Abnormal cognition and speech - causing difficulty in comprehension, expression and signing informed consent 3)Age below 18 and above 60 years. 4)Pregnancy, lactating mothers.

Design outcomes

Primary

Measure	Time frame
Changes in symptoms of chemotherapy induced peripheral neuropathy based on: 1)FACT/GOG-NTX- Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity questionnaire 2)EORTC QLQ-CIPN20- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale 3)P-QAS- Pain Quality Assessment ScaleTimepoint: On 22nd day	—

Measure

Time frame

Changes in symptoms of chemotherapy induced peripheral neuropathy based on: 1)FACT/GOG-NTX- Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity questionnaire 2)EORTC QLQ-CIPN20- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale 3)P-QAS- Pain Quality Assessment ScaleTimepoint: On 22nd day

—

Secondary

Measure	Time frame
Change in grade of peripheral neuropathy based on NCI-CTCAEv5Timepoint: On 22nd day	—

Countries

India

Contacts

Public ContactDr Sreejith K

Amrita School of Ayurveda

ammassankar@gmail.com09447498812

Outcome results