Exploring Ayurvedic Combinations in Treatment of Oral Premalignant lesions and Oral Cancer and Integration with Modern Medicine : A Clinical Study

A Single-center, Investigator-blinded, Randomized, 24-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of Combination of Ayurvedic Therapy as Add-on treatment Versus Standard treatment in Oral Pre-malignant Lesions and Early Oral Cancer - AYURCAN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083289

Enrollment

338

Registered

2025-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue Health Condition 2: C009- Malignant neoplasm of lip, unspecified Health Condition 3: C029- Malignant neoplasm of tongue, unspecified Health Condition 4: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 5: C060- Malignant neoplasm of cheek mucosa Health Condition 6: C069- Malignant neoplasm of mouth, unspecified Health Condition 7: K135- Oral submucous fibrosis Health Condition

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with clinical characteristic of pre-malignant lesions including Leukoplakia and Erythroplakia whose diagnosis will be confirmed with histology. 2. Patients with clinical characteristic of Oral Submucous Fibrosis (OSMF). 3. Patients with Oral Squamous Cell Carcinoma (OSCC) with lesion less than 2 cm in size cT1 4. Patients with Carcinoma in situ and dysplasia on histopathology 5. No evidence of cervical lymph node metastasis and distant metastasis. 6. No history of prior treatment for the same. 7. Patients who have quit the habit and accepted for regular follow up. 8. Patients having a mouth opening, ranging from 15-35 mm will be included in the study

Exclusion criteria

Exclusion criteria: 1. Patients not willing to give consent for participation. 2. Patients with locally advanced Oral squamous cell carcinoma 3. Patients with Oral Lichen Planus 4. Patients with cardiac, respiratory, renal, and hepatic diseases. 5. Pregnant women and lactating mothers. 6. Patients with Autoimmune diseases 7. Patients with Uncontrolled Diabetes and Hypertension 8. Patients with severe Trismus with mouth opening less than 15 mm 9. Patients with HIV and those who are Immunocompromised 10. Patients with hypersensitivity to Ayurveda drugs. 11. Patients not willing to quit the use of addictive substances

Design outcomes

Primary

Measure	Time frame
1. Ki67 index and Biological Markers (COX2, P53) in Oral Lesion 2. change in symptom score (measured by Visual Analogue Scale) and Mouth opening (measured by Inter-incisal distance) in patients with Oral Submucous fibrosis 3. clinical response (assessed by change in appearance on clinical photographs) and change in size (measured by geometric scale in 2 dimensions) among the oral lesionsTimepoint: 1. Clinical assessment on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 2. Ki67 index and Biological Markers (COX2, P53) on Day 0, Day 30(Oral Cancer) and Day 60 (Premalignant lesion)	—

Measure

Time frame

1. Ki67 index and Biological Markers (COX2, P53) in Oral Lesion 2. change in symptom score (measured by Visual Analogue Scale) and Mouth opening (measured by Inter-incisal distance) in patients with Oral Submucous fibrosis 3. clinical response (assessed by change in appearance on clinical photographs) and change in size (measured by geometric scale in 2 dimensions) among the oral lesionsTimepoint: 1. Clinical assessment on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 2. Ki67 index and Biological Markers (COX2, P53) on Day 0, Day 30(Oral Cancer) and Day 60 (Premalignant lesion)

—

Secondary

Measure	Time frame
1. Change in histopathology (assessed by histopathology/cytology) in the target lesion 2. QoL (measured by change in EORTC QLQ – H&N43 score) among the study groups 3. Safety and tolerability of the Ayurveda treatmentTimepoint: day 15, day 30, day 60, day 90 and day 120	—

Countries

India

Contacts

Public ContactKiran Kumar Prathipati

All India Institute of Medical Sciences Nagpur

drpkirankumar86@gmail.com9515657003

Outcome results