Clinical study on Turmeric mouth wash in the treatment of Oral ulcers due to cancer therapy.
- Conditions
- 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
The study is an open label comparative three-arm randomized parallel clinical study in which 2 variants of Turmeric Oral Rinse will be compared with normal saline for the efficacy and safety in patients during cancer chemotherapy and radiotherapy. Forty five ssubjects who fulfil the inclusion criteria will be selected. They will be randomised to one of the three groups namely Turmeric oral rinse variant 1 (Turmeric oral rinse with xanthine gum), Turmeric oral rinse Variant 2 (Turmeric oral rinse without xanthine gum) and Normal saline of 15 cases each. The subjects will be advised to use 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day. The subjects will be instructed to attend for follow up at the end of every week for 6 weeks. The study was conducted at single centre in India.
The primary outcome measures were Clinical assessments of Mucositis as per the World Health Organisation grading.
Outcome measures were measured 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 grading 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 Difficulty in drinking 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 ulcers 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 ulcers 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 Burning sensation 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 chewing 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 mouth 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
Trial Locations
- Locations (1)
M S Ramaiah Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
M S Ramaiah Medical College and Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Kirthi KoushikPrincipal investigator09901845412kirthi.koushik@gmail.com