CTRI/2015/10/006296招募中2 期
Clinical Validation of Unani Pharmacopoeial formulation “Sharbat Toot Siyah†in cases of Waram-i-Halaq (Pharyngitis)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 4
- 主要终点
- Improvement in signs and symptoms of Waram-i-Halaq (Pharyngitis)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Waram-i-Halaq (Pharyngitis) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessedclinically on Baseline, 3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Sharbat Toot Siyah
| S. No. |
Unani Name
Scientific Name
Weight
|1.
Aab-e-Toot Siyah
Morusnigra Linn.
1litre
|2.
Qand Safaid
Honey or sugar
1.5kg
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex in the age group of 18-60 years.
- •2.Presence of all of the following signs and symptoms of Waram-i-Halaq (Pharyngitis): 1.Buhha al-Sawt (Hoarseness of Voice) 2.Surfa Yubsiyya (Dry Cough) 3.‘Usr al-Bal (Dysphagia) 4.HumÄma Bul’ūm (Pharyngeal Erythema 5.Waja–e-halaq (Pain in throat).
- •6.Khushuna al-Halaq (Irritation in throat).
排除标准
- •1.Patients with all four classic symptoms of Group A Streptococcal pharyngitis: •Pharyngeal or Tonsillar exudates •Swollen anterior cervical nodes •History of fever more than 380 C •Absence of cough 2.Known cases of Renal/ Hepatic/ Cardiac ailments/ Diabetes mellitus 3.Pregnant and lactating women 4.Oral candidiasis 5.Epiglottitis, 6.Herpes Simplex 7.Mononucleosis 8.Gastro esophageal reflux.
结局指标
主要结局
Improvement in signs and symptoms of Waram-i-Halaq (Pharyngitis)
时间窗: 1 WEEK
次要结局
- Haematological and biochemical assessment for safety assessment(1 WEEK)
研究者
研究点 (4)
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