This is a clinical study to assess the effectiveness and safety of the Drizlin moisturizing bio-patch for treating patients who have below average salivary flow.
- Conditions
- Health Condition 1: K117- Disturbances of salivary secretion
- Registration Number
- CTRI/2024/03/063722
- Lead Sponsor
- Bylin Medtech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients whose salivary flow rate7 is less than 0.1 ml/min (subsets - Sjogren’s syndrome & drug-induced xerostomia);
2. Patients who fall under any one of the following categories:
a. Post-radiotherapy patients (= 6 months) who
underwent treatment for head & neck cancers.
b. Who are diagnosed with Sjogren’s syndrome;
c. Who are diagnosed with drug-induced xerostomia;
3. Patients who are willing to give voluntary written informed consent
1. Patients who are currently under chemotherapy;
2. Patients who are terminally ill and are having any other condition, in the opinion of the investigator, which would affect the safety of the patient;
3. Patients with known history of hypersensitivity to mucosal patches;
4. Female patients who are breast-feeding/ pregnant, or intends to become pregnant during the clinical investigation.
5. Patients who participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Change in dryness of mouth score based on VAS scale. <br/ ><br> <br/ ><br>2) Treatment discontinuation rates: Early discontinuation, discontinuation due to study device-related adverse events.Timepoint: Baseline to end of study.
- Secondary Outcome Measures
Name Time Method 1) Change in burning sensation of buccal cavity based on VAS scale <br/ ><br> <br/ ><br>2) Change in the moistness of oral cavity based on VAS scale <br/ ><br> <br/ ><br>3) Change in nocturnal urinary frequency per day (subsets –Sjogren’s syndrome & drug-induced xerostomia) <br/ ><br> <br/ ><br>4) Change in speaking difficulty based on VAS scale <br/ ><br> <br/ ><br>5) Number & percentage of patients with study device-related adverse events. <br/ ><br> <br/ ><br>6) Feedback on ease in the removal of moisturizing bio-patch at the end of the clinical investigation. <br/ ><br> <br/ ><br>7) Change in simplified oral hygiene index (OHI-S)9 on a score of 0 – 6Timepoint: Baseline to end of study.