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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Ministry of AYUSH
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Clinical evaluation for changes in grading of oral Mucositis according to WHO Scale
Study Overview
Brief Summary
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A total of 80 Patients will be recruited in the project titled ’’A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF TRIPHALA RASAYANA AND HARIDRADI TAILA GANDUSHA IN CHEMO /RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CARCINOMA’’ after taking into consideration the inclusion & exclusion criteria.
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The participants will be randomly allocated into two groups:
Group A: 40 patients
Group B: 40 patients
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Detailed Clinical evaluation, blood investigations and the necessary questionnaire will be filled.
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After the mucositis develops patients will be treated according to the allotted group:
Group A : Participants receiving Ayurvedic Treatment
Group B: Participants receiving Conventional Treatment
- Patients will be followed up at regular intervals: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Oral, Oropharynx & Laryngeal Cancer patients diagnosed as Squamous Cell Carcinoma (Stage I to Stage IV).
- •Participants who are on conventional therapy (post-surgery radiotherapy and or chemotherapy with radiation, and chemotherapy).
- •3.Patients having Karnofsky Performance Status between 90-
- •4.Patients who will voluntarily give consent to participate in the study.
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.
Outcomes
Primary Outcomes
Clinical evaluation for changes in grading of oral Mucositis according to WHO Scale
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks
Change in Quality of life in terms of EORTC QLQ C30.
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks
Secondary Outcomes
- Change in sleep quality in terms of Pittsburgh Sleep Quality Index (PSQI)(Baseline, 12 week, 20 week & 60 week)
- Change in anxiety and depressive symptoms in terms of Hospital Anxiety and Depression Scale (HADS)(Baseline, 12 week, 20 week & 60 week)
- Change in Pain in terms of Brief Pain Inventory (BPI)(Baseline, 12 week, 20 week & 60 week)
- Change in ECOG Performance Status and Karnofsky Performance Status(Baseline, 12 week, 20 week & 60 week)
- Change in Hematological & Inflammatory markers(Baseline, 4 weeks, 12 weeks, 20 weeks & 60 weeks)
Investigators
Dr Sunita Gupta
Maulana Azad Institute of Dental Sciences