Health Condition 1: null- Subjects with head and neck cancer scheduled to receive chemotherapy or radiotherapy as standard care and with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy
Conditions
Interventions
Intervention1: Turmeric oral rinse variant 1: Turmeric oral rinse variant 1 (Turmeric oral rinse with xanthine gum)
To be used 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a d
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects with confirmed histopathologically with head and neck cancer (according to TNM classification) preferably oropharyngeal scheduled to receive chemotherapy or radiotherapy as a standard care. 2 Subjects with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy. 3 Subjects aged >18 years of either the sex. 4 Subjects willing to give a written informed consent and follow the schedule of the study as per the protocol.
Exclusion criteria
Exclusion criteria: 1 Has participated in a similar clinical investigation in the past four weeks. 2 Severe uncontrolled systemic disorders, diabetes, Hypertension, or genetic and endocrinal disorders. 3 Has used a similar product in the past four weeks. 4 Subjects who refused to sign informed consent. 5 Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical assessment of Mucositis as per the World Health Organisation gradingTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek | — |
Secondary
| Measure | Time frame |
|---|---|
| Burning sensationTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek;Difficulty in chewingTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek;Difficulty in drinkingTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek;Difficulty in opening the mouthTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek;Location of ulcersTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek;Number of ulcersTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek | — |
Countries
India
Contacts
Public ContactDr Padmanabha
M.S.Ramaiah Hospital
Outcome results
None listed