AYURVEDIC INTERVENTIONS IN RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CANCER PATIENTS

RANDOMIZED CLINICAL CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AYURVEDA INTERVENTIONS (TRIPHALA RASAYANA, HARIDRADI TAILA GANDUSHA) IN CHEMO /RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CARCINOMA - CHEMO- Chemotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086856

Enrollment

Registered

2025-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C050- Malignant neoplasm of hard palate Health Condition 3: C108- Malignant neoplasm of overlappingsites of oropharynx Health Condition 4: C090- Malignant neoplasm of tonsillar fossa

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Oral, Oropharynx & Laryngeal Cancer patients diagnosed as Squamous Cell Carcinoma (Stage I to Stage IV). 2. Participants who are on conventional therapy (post-surgery radiotherapy and or chemotherapy with radiation, and chemotherapy). 3.Patients having Karnofsky Performance Status between 90-60. 4.Patients who will voluntarily give consent to participate in the study

Exclusion criteria

Exclusion criteria: Evidence of immediate life-threatening disease or a life expectancy of less than 3 months Evidence of significant renal, hepatic, hematologic, or immunologic disease. Inability to eat soft solid food at baseline Patients who are judged by the investigators to be unsuitable to participate in the study.

Design outcomes

Primary

Measure	Time frame
Clinical evaluation for changes in grading of oral Mucositis according to WHO Scale Change in Quality of life in terms of EORTC QLQ C30.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks	—

Secondary

Measure	Time frame
Change in sleep quality in terms of Pittsburgh Sleep Quality Index (PSQI)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in anxiety and depressive symptoms in terms of Hospital Anxiety and Depression Scale (HADS)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in Pain in terms of Brief Pain Inventory (BPI)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in ECOG Performance Status and Karnofsky Performance StatusTimepoint: Baseline, 12 week, 20 week & 60 week;Change in Hematological & Inflammatory markersTimepoint: Baseline, 4 weeks, 12 weeks, 20 weeks & 60 weeks	—

Measure

Time frame

Change in sleep quality in terms of Pittsburgh Sleep Quality Index (PSQI)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in anxiety and depressive symptoms in terms of Hospital Anxiety and Depression Scale (HADS)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in Pain in terms of Brief Pain Inventory (BPI)Timepoint: Baseline, 12 week, 20 week & 60 week;Change in ECOG Performance Status and Karnofsky Performance StatusTimepoint: Baseline, 12 week, 20 week & 60 week;Change in Hematological & Inflammatory markersTimepoint: Baseline, 4 weeks, 12 weeks, 20 weeks & 60 weeks

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Countries

India

Contacts

Public ContactDr Sunita Gupta

Maulana Azad Institute of Dental Sciences

profsunitamamc@gmail.com9810192165

Outcome results