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临床试验/CTRI/2024/03/063687
CTRI/2024/03/063687招募中2 期

A randomized parallel-group single-blinded vehicle-controlled clinical study to evaluate efficacy and safety of Naṭūl (Irrigation therapy) with Ravghan-i-Nilofar in Sahar (Insomnia)

Hakim Syed Ziaul Hasan Govt./(Auto)Unani Medical College & Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月12日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Insomnia is defined as “a persistent difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity and circumstances for sleep, and results in some form of daytime impairment”. Various studies conducted worldwide have revealed that the prevalence of insomnia is 10%-30% of the population, some even as high as 50%-60%. Insomnia is more common in women, older persons and those who are struggling financially.

Insomnia is described as Sahar in the Unani system of Medicine which is characterized by Sleeplessness or Excessive Awakening.

In Conventional Medicine, several antidepressant and hypnotic drugs are frequently used for the treatment of Insomnia like tricyclic antidepressants (Doxepin), serotonergic antidepressants (Dapoxetine) hypnotic drugs (Triazolam, Temazepam, Flurazepam, Alprazolam, Clonazepam and Lorazepam). These drugs have many side effects, especially addiction.).

Researchers are trying to resort to natural treatment because of the present side effects scenario. Unani Medicine has become valuable because Sahar has been successfully treated since ancient times without noticeable adverse effects on the body.

Naṭūl (Irrigation Therapy) with oils or decoction of various herbs has been already employed in the treatment of Sahar successfully by ancient Unani Physicians. Ibn Sīnā recommended that the use of Naṭūl especially with Ravghan-i-Nilofar is beneficial in the management of Sahar.

Naṭūl (Irrigation Therapy) is a classical and effective therapy in ‘Ilāj bi’l Tadbīr which is described as the pouring or dripping of medicated decoction or warm water on desired organs. Naṭūl accelerates the processes of Ikhrāj-i-Mawād (Evacuation of Morbid Material) and Ta‘dīl-i-Mizāj-i-A‘ḍā’ (To Balance the Temperamental State of the Organ) and improves Quwwat-i-Mudāfi’at (Defence Mechanism of Body). This produces essential Neurological, Psychological, and Pharmacological benefits for several disorders. It also enhances local absorption of the medicine which helps to get desired actions.

Based on the above discussions, it is hypothesized that Naṭūl with Ravghan-i-Nilofar may be beneficial in the management of Sahar (Insomnia).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patients have an Insomnia Severity Index between 8-
  • Patient willing to participate in the study.

排除标准

  • Pregnant & lactating women.
  • Severe co-morbid patients.
  • Severe psychotic patients.
  • Patients who will be unwilling to participate in the study.

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: Baseline (BL), 3rd day, 5th day, 8th day, 13th day and 21st day

次要结局

  • Trying to provide a Standard Operative Procedure (SOP)(Baseline and 21st day)

研究者

发起方
Hakim Syed Ziaul Hasan Govt./(Auto)Unani Medical College & Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Meraj

Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.)

研究点 (1)

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