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Treatment of mouth ulcer with Unani medicine Habb-e â??Qula

Phase 3
Conditions
Health Condition 1: K120- Recurrent oral aphthae
Registration Number
CTRI/2021/05/033782
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Subjects of either sex in the age group of 18-65 years

2. Subjects with presence of single /multiple ulcers on the non-keratinized mucosa (labial, soft palate, buccal mucosa)

With and without any of the following symptoms

o Pain or burning sensation

o Excessive salivation

2. Subjects with minor Aphthous Ulcers less than 1 cm in diameter

Exclusion Criteria

1. Traumatic ulcers

2. Disorders requiring long term treatment

3. Known cases of underlying systemic diseases such as Crohnâ??s disease, ulcerative colitis, Celiac disease, lupus erythematosus, Behcetâ??s disease, Cyclic neutropenia, immunodeficiency disorders, lichen planus and malignancy

4. Subjects with moderate to severe anemia

5. Known allergy to any component of the test drug.

6. Pregnant and lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in sign and symptoms of QulÄ? (Aphthous Ulcer)Timepoint: The patients will be assessed clinically at Day 0, Day 3 , Day 7 and Day 10
Secondary Outcome Measures
NameTimeMethod
Haematological and biochemical assessment for safety assessmentTimepoint: Investigations will be done at baseline and end of treatment
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