Efficacy of Munzij wa Mushil-i-safra and Saut with Roghan-i-kaddu in Usabah (Chronic Tension Type Headache)-A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for intensity of headache (VAS)
研究概览
简要总结
Purpose-Efficacy of Munzij wa Mushil-i-safra and Sa’ut with Roghan-i- Kaddu in Usabah (Chronic Tension Type Headache) - A Randomized Controlled Clinical Trial
Study design: Open Labelled, Randomized Controlled Clinical Trial
Intervention- In Test group Munzij wa Mushil-i-Safra and Sa’ut with Roghan kaddu will be given Munzij-i-Safra: from 1st day to 10th day Mushil-i-Safra: on 5th and 10th day. Sa’ut with Roghan kaddu: from 11th day to 28th days. The patients in control group will recieve Transcutaneous Electrical Nerve Stimulation (TENS) TENS- Thrice weekly for 28 days.
Main outcome measures-
Primary outcome: Visual Analogue Scale for intensity of headache (VAS)
Secondary outcome: Headache Impact Test (HIT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 from 18 to 65 years of age
- •Patients of all gender
- •Patients conforming to ICHD3 diagnostic criteria of CTTH
- •Intensity of headache score on VAS equal or more than 3
- •Agree to participate in this study and provide written informed consent.
排除标准
- •1.Headache caused by other medical disorders (e.g. Known case of subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, head injury, hypertension, migraine, headache due to ophthalmic cause)
- •Patients having any serious co-morbidity involving liver, kidney, cardiovascular, endocrinal and metabolic disorders etc.
- •Pregnant or lactating women
- •Known case of nasal block (polyps, DNS, Turbinate hypertrophy)
- •External injury to nose
- •Patients with pace maker and metallic implant
- •Known case of epilepsy
- •Patients not willing to follow the protocol.
结局指标
主要结局
Visual Analogue Scale for intensity of headache (VAS)
时间窗: 0-14-28 day
次要结局
- Headache Impact Test (HIT)(0-14-28 day)
研究者
Tooba Tabassum
National Institute Of Unani Medicine Bangalore
