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临床试验/CTRI/2019/06/019755
CTRI/2019/06/019755尚未招募3 期

RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY OF VIDANG TAILANASYA AND GOGHRITA NASYA IN THE MANAGEMENT OF ARDHAVBHEDAK

Pallavi Pandurang Vyavahare1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年6月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Subjective criteria ( by using Grades and Visual analogues Pain Scale)

研究概览

简要总结

  1. Screening of patient of Ardhavbhedak will be done using a purposive sampling method. Followed by random sampling by lottery method, who meets the inclusion criteria, till the desired sample size is achieved.
  2. 72 Patient of Ardhavbhedak will be purposively selected in OPD/IPD basis irrespective of of gender, economic status, religion, occupation.
  3. 72 Patient will be allocated randomly into two groups-by Lottery methods.
  4. Group A (Trial Group): 36 patients will be treated with Vidang Taila Nasya for 7 days    Dose: 2 drops (1/2 ml)  Group B (Control Group):36 patients will be treated with Goghrita NasyaFor 7 days Dose: 2 drops (1/2 ml).
  5. Criteria for assessment -
subjective criteria will assess  will be assessed with help of  scoring pattern, Vas scale

Objective criteria will be assess with the help of Grading Pattern

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient suffering from symptoms of Ardhavbhedak i.e. Ardha Manya, Bhru, Shankha, Karna, Akshi, Lalat Ativedanam and Shastra Arni Nibha and Bhrama Patient between age group 20 to 60 yrs.
  • Patient of either gender.

排除标准

  • Patients suffering from sinusitis systemic disorders like hypertension and dibetes Secondary headache caused by meningitis tumor encephalitis and refractive errors Pregnancy and lactation.

结局指标

主要结局

Subjective criteria ( by using Grades and Visual analogues Pain Scale)

时间窗: 21 days

Bhrama (giddiness)

时间窗: 21 days

Shatra Arni Nibha (Throbbing pain)

时间窗: 21 days

Unilateral severe pain affecting neck brow ear and orbital area forehead region

时间窗: 21 days

Objective criteria (by Gradation)

时间窗: 21 days

1 severity of headache

时间窗: 21 days

2 frequency of headache

时间窗: 21 days

3 duration of headache

时间窗: 21 days

4 Episode of Vomiting

时间窗: 21 days

4 Duration of Aura

时间窗: 21 days

次要结局

  • Study the concept of Ardhavbhedak and Migraine in details(Study the Nasya Kriyakalpa and its uses indications contra indications complications)

研究者

发起方
Pallavi Pandurang Vyavahare
申办方类型
Other [self]

研究点 (1)

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