Clinical study on Validation of Unani Pharmacopoeial formulation Habb e Qula in QulÄ (Aphthous Ulcer)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Improvement in sign and symptoms of QulÄ (Aphthous Ulcer)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with QulÄ (Aphthous Ulcer) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at Day 0, Day 3 , Day 7 and Day 10. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 10days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Pharmacopoeial Formulation ‘Habb-e- Qula’
| S. No. |
Ingredients
Botanical/Scientific Name
Part Used
Quantity
|1.
Raihan
Ocimum sanctum Linn.
Leaf
50g
|2.
Sang-e-Jarahat
Hydrated Magnesium Silicate
_____
50g
|3.
Sandal Safaid
Santalum album Linn.
Bark
50g
|4.
Zar-e-Ward
Rosa damascene Linn.
Pollen Grains
50g
|5.
Heel Khurd
ElettariacardamomumMaton.
Seeds
50g
|6.
Araq-e-Gulab
Rosa damascenaLinn.
Distillate of Petals
50g
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex in the age group of 18-65 years
- •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
- •Subjects with minor Aphthous Ulcers less than 1 cm in diameter.
排除标准
- •Traumatic ulcers
- •Disorders requiring long term treatment
- •Known cases of underlying systemic diseases such as Crohn’s disease, ulcerative colitis, Celiac disease, lupus erythematosus, Behcet’s disease, Cyclic neutropenia, immunodeficiency disorders, lichen planus and malignancy
- •Known allergy to any component of the test drug.
- •Pregnant and lactating women.
结局指标
主要结局
Improvement in sign and symptoms of QulÄ (Aphthous Ulcer)
时间窗: The patients will be assessed clinically at Day 0, Day 3 , Day 7 and Day 10
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)