A single-arm, multicentre, clinical validation study to Evaluate the Safety and Efficacy of a Unani Pharmacopoeial formulation, Qurs-e-Tabasheer Mulaiyin in Khushanat-i-Halq (Irritation of Throat)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Improvement in the signs and symptoms of Khushunat-e-Halaq (Irritation of Throat). Which will be assessed on the basis of the VAS score.
研究概览
简要总结
This study is designed as a multi centric open trial in patients with Khushunat-e-Halaq (Irritation of Throat) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline, first follow up and at the end of treatment. (i.e., 0, 7th and 14th day) . This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 14 Days. Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion of the protocol therapy (i.e., 0, 7th and 14th day).
Composition of Study drug: Qurs-e-Tabasheer Mulaiyin
| S. No. |
Ingredients
Scientific/Botanical name
Quantity
|1.
Tabasheer
Bambusa arundinaceae (Retz.) Roxb.
4 parts
|2.
Turanjabeen
Alhagi pseudalhagi (Bieb.) Desv
3 parts
|3.
Maghz-e-Tukhm-e-Khiyarain
Cucumis sativa seed
1 part
|4.
Maghz-e-Tukhm-e-Kaddu
Laginaria siceraria seed
1 part
|5.
Nishasta-e-Gandum
Triticum sativum
1 part
|6.
Samgh-e-Arabi
Acacia arabica
1 part
|7.
Kateera
Tragacanth gum
1 part
|8.
Khashkhaash Safaid
Papaver somniferum seed
1 part
|9.
Loab-e-Aspaghol
Plantago ovata Forsk
Q.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having Throat irritation with or without any of the following symptoms:
- •Hoarseness of voice
- •Dysphagia
- •Pharyngeal erythema
- •Pain in throat
- •Post nasal drip.
排除标准
- •Known cases of fungal and bacterial pharyngitis.
- •Patients with all classic symptoms of Group A Streptococcal Pharyngitis: i.
- •Red and swollen tonsils ii.
- •Tonsillar exudates (white patches /streaks of pus) iii.
- •Absence of cough
- •High grade fever 4.Known cases of Epiglottises.
- •Known cases of Oral candidiasis.
- •Known cases of Herpes simplex.
- •7.Known cases of Renal or Hepatic or Cardiac ailments.
- •8.Pregnant and lactating women.
结局指标
主要结局
Improvement in the signs and symptoms of Khushunat-e-Halaq (Irritation of Throat). Which will be assessed on the basis of the VAS score.
时间窗: At baseline, first follow up and at the end of treatment. (i.e., 0, 7th and 14th day)
次要结局
- Haematological and biochemical investigations for safety assessment i.e.,Haemogram, AEC, LFT, KFT, CRP and Urine R/M.(At baseline, first follow up and at the end of treatment. i.e., 0, 7th and 14th day)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)