Managing Radiation Side Effects with Nilikadi Ghrita in Head and Neck Cancer

Efficacy of Nilikadi Ghrita with or without Standard of Care for Radiation-Induced Acute Toxicities Among Head and Neck Cancer Patients : A Comparative Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109404

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: Y842- Radiological procedure and radiotherapy as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis: Histologically confirmed SCC of head and neck planned for external beam radiotherapy EBRT with curative or definitive intent RT related: Patient scheduled to receive radiation with EBRT to a primary site. Total Dose: 6000-6600 Cgy Fractionation schedule: Total Fractions should be 30 to 35 as required in 5 to 8 weeks, 5 days a week If required the split is to be given after 15-20 fractions. A split usually lasts for 2 weeks. SSD 80 to 100 cm RT intent curative or definitive as organ preserving

Exclusion criteria

Exclusion criteria: 1) Prior radiotherapy to the same anatomical region that would confound toxicity. 2) Known hypersensitivity to any component of the investigational product. 3) Any other condition which, in the investigator s opinion, makes the patient unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of radiation-induced toxicities using RTOG toxicity grading criteriaTimepoint: Screening: 3-5 days before planning of RT Monitory follow-up: Once a week during RT (7th day) Follow up: Post treatment: 2nd & 4th week post RT	—

Secondary

Measure	Time frame
1) Quality of Life (QoL) : Change in Quality of Life scores assessed using EORTC QLQ-C30 and/or EORTC QLQ-H&N35Timepoint: Baseline (pre-radiotherapy), mid-treatment (Week 3 4; optional), End of Radiotherapy (EOT), and 1 month post-radiotherapy;2) Patient Compliance : Percentage of prescribed doses of Nilikadi Ghrita consumed and number of missed dosesTimepoint: Daily recording, weekly during radiotherapy, and final assessment at End of Radiotherapy (EOT)	—

Measure

Time frame

1) Quality of Life (QoL) : Change in Quality of Life scores assessed using EORTC QLQ-C30 and/or EORTC QLQ-H&N35Timepoint: Baseline (pre-radiotherapy), mid-treatment (Week 3 4; optional), End of Radiotherapy (EOT), and 1 month post-radiotherapy;2) Patient Compliance : Percentage of prescribed doses of Nilikadi Ghrita consumed and number of missed dosesTimepoint: Daily recording, weekly during radiotherapy, and final assessment at End of Radiotherapy (EOT)

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Countries

India

Contacts

Public ContactDr Ritu Kapoor

Post graduate institute of Ayurved

drritukapoor4@gmail.com9529831215

Outcome results