Exploring the Benefits of Ananta Vati, a Herbal Remedy, in Reducing Radiation Side Effects in Oral Cancer Patients

Radioprotective potential of Ananta Vati A herbal formulation from roots of Decalepis hamiltonii Wight and Arn against radiation induced side effects in oral cancer patients A Pilot Randomized Controlled Study - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083100

Enrollment

Registered

2025-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histopathologically, diagnosed oral cavity cancer participants. 2. Participants with stages I-IV oral cancer for radiotherapy (either after surgery or as a primary) with or without concurrent chemotherapy. 3. Participants of age group 18 -75 years of both sexes, irrespective of co-morbidities. 4. Total dose in between 50 to 70 Gy and exposure of at least half of oral cavity to radiation. 5. Total Fractions 25-35 # as required in 5 - 6 weeks cycle.

Exclusion criteria

Exclusion criteria: 1. Participants taking palliative radiotherapy. 2. Participants with renal failure (eGFR less than 50 ml per min) and hepatic failure (serum transaminase levels 2 3 times higher than the upper limit of normal). 3. Participants with severe infection requiring antibiotic therapy. 4. Participants who already had active oral diseases, including oropharyngeal candidiasis and facial herpes, stomatitis, or other oral diseases. 5. Participants with a history of allergy to Ananta or previous radiotherapy. 6. Participants receiving nonsteroidal anti-inflammatory drugs or corticosteroids

Design outcomes

Primary

Measure	Time frame
1.The assessment of radiation-induced side effects like mucositis, trismus, xerostomia, radiation caries, dysgeusia, dysphagia, hoarseness of voice, and orofacial pain, using standardized scales such as the Common Terminology Criteria for Adverse Events (CTCAE) criteria to measure the severity of radiation-induced side effects 2. To asses the functional impairment as well as effect on the quality of life of oral cavity cancer patients, utilizing validated QoL questionnaires like the European Organization of Research & Treatment of Cancer (EORTC) QLQ-C30 & H&N 43 and Karnofsky Performance scoreTimepoint: A - Day 0;1 week before starting Radiotherapy B - Day 8; Start of Radiotherapy C - Mid of Radiotherapy D - At the end of Radiotherapy), and E - 1 month after the end of Radiotherapy	—

Measure

Time frame

1.The assessment of radiation-induced side effects like mucositis, trismus, xerostomia, radiation caries, dysgeusia, dysphagia, hoarseness of voice, and orofacial pain, using standardized scales such as the Common Terminology Criteria for Adverse Events (CTCAE) criteria to measure the severity of radiation-induced side effects 2. To asses the functional impairment as well as effect on the quality of life of oral cavity cancer patients, utilizing validated QoL questionnaires like the European Organization of Research & Treatment of Cancer (EORTC) QLQ-C30 & H&N 43 and Karnofsky Performance scoreTimepoint: A - Day 0;1 week before starting Radiotherapy B - Day 8; Start of Radiotherapy C - Mid of Radiotherapy D - At the end of Radiotherapy), and E - 1 month after the end of Radiotherapy

—

Secondary

Measure	Time frame
1. . Hematological parameters like haemoglobin, leukocytes, plateletsTimepoint: Timepoint A (Day 0) and E (1 month after end of radiotherapy).	—

Countries

India

Contacts

Public ContactSneha Surve

Tilak Ayurved Mahavidyalaya

apoorvasangoram@gmail.com9822090305

Outcome results