Clinical study on Turmeric mouth wash in the treatment of Oral ulcers due to cancer therapy.
- Conditions
- 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
- Registration Number
- CTRI/2018/03/012371
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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