Clinical comparative efficacy and safety of Polyherbal Unani formulations.
- Conditions
- Health Condition 1: K120- Recurrent oral aphthae
- Registration Number
- CTRI/2023/02/049696
- Lead Sponsor
- State Unani Medical College, himmatganj Prayagraj
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Patients of any sex in the age group of 18-65 years
2.Presence of single/multiple ulcers in the oral cavity or tongue with the presence of any of the following symptoms
Difficulty in any eating/chewing/speaking/swallowing or burning sensation, pain in the oral cavity,coated tongue, excessive salivation
3.Patients clinically diagnosed with Qul ? (Aphthous stomatitis)
The following patients will be excluded
1.Pregnant and lactating mothers.
2.Patient with severe renal, hepatic, and cardiac disease.
3.Those who have a history of systematic underlying disease (Crohn’s disease, Ulcerative Colitis, Behcet’s syndrome, Sweet’s Syndrome, Lupus erythematosus) and Diabetes mellitus.
4.Those diagnosed with oral cavity carcinoma.
5. Patient of hypertension.
6.Patient unsure about attending treatment schedule regularly.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. LIKERT Scale:-Difficulty in eating, chewing, uneasiness in swallowing and speaking will <br/ ><br>be assessed on a LIKERT Scale: <br/ ><br>Grade 0 – None of the time <br/ ><br>Grade 1 – some of the time <br/ ><br>Grade 2 – Most of the time <br/ ><br>Grade 3 – all of the time <br/ ><br> <br/ ><br>2. ten-point Visual Analog Scale (VAS):-the following symptoms will be assessed on a ten-point Visual Analog <br/ ><br>Scale (VAS) <br/ ><br>• Burning sensation in the mouth <br/ ><br>• Excessive salivation <br/ ><br>• Coated tongueTimepoint: Baseline , 1 and 2 weeks
- Secondary Outcome Measures
Name Time Method • No. of ulcers in the oral cavity <br/ ><br>Grade 0 - No ulcer <br/ ><br>Grade 1 - 1-3 <br/ ><br>Grade 2 – 4-6 <br/ ><br>Grade 3 - =7 <br/ ><br>Timepoint: 0 and 13th day