Health Condition 1: K12- Stomatitis and related lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with presence of single/multiple ulcers on the non- keratinized mucosa (labial, soft palate, buccal mucosa) with/ without any of the following symptoms: 1. Difficulty in eating/chewing/swallowing/speaking. 2. Pain or burning sensation. 3. Excessive salivation.
Exclusion criteria
Exclusion criteria: 1. Subjects with Aphthous Ulcers more than 1cm in diameter. 2.Patients with Traumatic ulcers. 3. Patients with disorders requiring long term treatment. 4. Known cases of underlying Gastro-intestinal diseases such as Crohn?s disease, ulcerative colitis etc. 5.Subjects with severe anemia i.e. Hb level less than 8 gm % 6. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and efficacy of Unani Pharmacopeial formulation Qulai in comparison with Zaroor Kath in Qulaa (Stomatitis) will be carried out on the basis of Visual Analog Scale (VAS)Timepoint: At 0, 7th and 14th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT,KFT.Timepoint: At baseline and at the end of treatment. i.e., 0 & 14th day. | — |
Countries
India
Contacts
Central Council for Research in Unani Medicine (CCRUM)