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临床试验/CTRI/2025/01/079475
CTRI/2025/01/079475尚未招募2 期

Efficacy of Munzij wa Mushil-i-safra and Saut with Roghan-i-kaddu in Usabah (Chronic Tension Type Headache)-A Randomized Controlled Clinical Trial

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年2月25日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Tooba Tabassum

National Institute Of Unani Medicine Bangalore

研究点 (1)

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