A Randomized parallel group clinical trial on effectiveness of Ayurvedic medicines in reducing adverse effects of radiotherapy, improving disease free survival, quality of life of oral cancer patients

A Randomized parallel group clinical trial on effectiveness of Ayurvedic medicines in reducing adverse effects of radiotherapy, improving disease free survival and quality of life assessed by criteria such as CTCAE, Karnofsky score and QLQ by EORTC, and assessing systemic immune response and oxidative stress of oral cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/01/007689

Enrollment

180

Registered

2017-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Health condition â??Oral cancer patients undergoing radiotherapy, Problem studied - Adverse effects of radiotherapy Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: MKD/SBD/YTG/AT/TFG/YTO/Radiotherapy: Study Group -1a will receive: Tab. MauktikyuktaKamadudha - 500 mg Morningâ??Evening (After light food) Suvarnabhasmadi Yoga - 395 mg Morningâ?? Even

Eligibility

Inclusion criteria

Inclusion criteria: Oral cavity cancer patients of all stages and grades, who are scheduled for radiotherapy (dose up to 6600 cGY in 30-35 fractions in 5-6 weeks), who are also treated with or without concurrent chemotherapy (Inj. Cisplatin, as booster therapy to radiotherapy)

Exclusion criteria

Exclusion criteria: Oral cavity cancer patients who have already received palliative radiotherapy and patients receiving curative chemotherapy along with radiotherapy

Design outcomes

Primary

Measure	Time frame
Adverse effects of Radiotherapy as per Common Toxicity Criteria (CTC)Timepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy	—

Secondary

Measure	Time frame
Blood SugarTimepoint: Day 0(Before Radiotherapy);Changes in CT scan (neck)Timepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Immune Parameters Like IL-1, IL-6, IL-8, IL-10, IFN Gamma, TNF -AlphaTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Kidney Function TestTimepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;changes in Liver Function TestTimepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Oxidative Stress by Catalase, SOD, GST, GSTP1 Hypermethylation Timepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Quality of Life Questionnaires (QLQ C30 and H&N35) of EORTC for Quality of LifeTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of r	—

Measure

Time frame

Blood SugarTimepoint: Day 0(Before Radiotherapy);Changes in CT scan (neck)Timepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Immune Parameters Like IL-1, IL-6, IL-8, IL-10, IFN Gamma, TNF -AlphaTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Karnofsky score â?? For performance statusTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Kidney Function TestTimepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;changes in Liver Function TestTimepoint: Day 0 (Before Radiotherapy),After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Oxidative Stress by Catalase, SOD, GST, GSTP1 Hypermethylation Timepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of radiotherapy, after 3 years of radiotherapy;Changes in Quality of Life Questionnaires (QLQ C30 and H&N35) of EORTC for Quality of LifeTimepoint: Day 0 (Before Radiotherapy), Day 22 (After Half Course of Radiotherapy), Day45 (After full course of radiotherapy), After 1 month of radiotherapy, After 3 months of radiotherapy, After 1 year of radiotherapy, after 2 years of r

—

Countries

India

Contacts

Public ContactDr Bhagyashree Sardeshmukh

Integrated Cancer Treatment and Research Centre, Wagholi, Pune

dhananjayrd123@gmail.com02067346124

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026