A Randomized, Open-Label, Parallel Group, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a Unani Pharmacopoeial formulation Qulai compared with Dharur Kath in the Treatment of Qula (Stomatitis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
This study is designed as a Single centric, Randomized, Parallel Group, Active Controlled trial in patients with Qulaa (Stomatitis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 0, 7th and 14th day. The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Pharmacopoeial Formulation ‘Qulai’
| S. No. |
Ingredients
Quantity
|1.
Hamiz Booraqi
Boric Acid
30 g.
|2.
Shahdeen
Glycerin
150 g.
Composition of Pharmacopoeial Formulation ‘Zaroor Kath’
| S. No. |
Tibbi Name
Scientific Name
Parts used
Quantity
|1
Zar-e- Ward
Rosa damascena Mill.
Pollen grains
1 part
|2
Kat Safed
Acacia catechu (Linn. f.) Willd.
Extract
-do-
|3
Dana Heel Khurd
Elettaria cardamomum (Linn.) Maton
Seeds
-do-
|4
Tabasheer
Bambusa arundinacea (Retz.) Roxb.
Siliceous secretion
-do-
|5
Kafoor
Cinnamomum camphora (Linn.) J. Presl
Extract
-do-
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with presence of single/multiple ulcers on the non- keratinized mucosa (labial, soft palate, buccal mucosa) with/ without any of the following symptoms:
- •Difficulty in eating/chewing/swallowing/speaking.
- •Pain or burning sensation.
- •Excessive salivation.
排除标准
- •Subjects with Aphthous Ulcers more than 1cm in diameter.
- •2.Patients with Traumatic ulcers.
- •Patients with disorders requiring long term treatment.
- •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 %
- •Pregnant and lactating women.
结局指标
主要结局
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)
时间窗: At 0, 7th and 14th day
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT,KFT.(At baseline and at the end of treatment. i.e., 0 & 14th day.)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)