跳至主要内容
临床试验/CTRI/2025/03/082889
CTRI/2025/03/082889尚未招募2 期

Clinical study to evaluate the therapeutic efficacy of Natul(Joshanda of Shibt, Susan, Babuna and Nakhuna) in the management of Izterab-i-Nafsani Umoomi (Generalized Anxiety Disorder).

Central Council for Research in Unani Medicine CCRUM New Delhi1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Hamilton Anxiety Rating Scale (HAM-A)

研究概览

简要总结

Anxiety defined as a subjective sense of unease, dread, or foreboding can indicate a primary psychiatric condition or can be a component of, or reaction to a primary medical disease. Anxiety disorders, the most prevalent psychiatric illnesses in the general community, are present in 15-20% of medical clinic patients. Generalized anxiety disorder (GAD) is characterized by persistent, excessive, and/or unrealistic worry associated with muscle tension, impaired concentration, autonomic arousal, feeling "on edge" with restlessness, and insomnia. The lifetime prevalence of GAD is 5-6%; the risk is higher in first-degree relatives of patients with the diagnosis. More than 80% of patients GAD also suffer from major depression, dysthymia, or social phobia. Primary anxiety disorders include Generalized Anxiety Disorder (GAD), Phobic disorders (social or specific), obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD). In Unani literature, there is description of Fikr (worry) which is used as synonym of Izterab-I-Nafsani. Literally Izterab-I-Nafsani stands for worry, excessive thinking, fear and hindrance in routine work.The description of anxiety disorders as such, is not found in Unani literature but their symptoms show a considerable overlap with other diseases, such as, like malankhuliya, waswas, maniya, sahr, hizyan, ishq and khafaqan etc. In malankhuliya, the mental functions of an individual are deranged leading to constant grief, fear, and dubious aggression. Modern management includes Cognitive behavioral therapy, deep muscle relaxation and drugs like Benzodiazepines, Selective Serotonin Receptor Uptake Inhibitors, Serotonin and Norepinephrine Reuptake Inhibitors and Beta Blockers, which are useful in short term, but long-term use can lead to dependence. Due to dependance, these drugs have many withdrawal symptoms like irritability, nausea, drowsiness, vomiting, nightmares, headache or paresthesias. On the other hand, Unani management includes use of Muqawwiyat (Tonics), Mufarrihat (Exhilarants) and Munaqqiyat  (Evacuants) along with some effective regiminal  therapies like Dalk (Massage), Natul (Irrigation), Suoot etc which work upon the principle of strengthening the essential organs and evacuation of morbid humor. In the current era of devastating effects on mental health, with the objective of improving the quality of life, a study entitled; clinical study to evaluate the therapeutic efficacy of Natul (joshanda of Shibt, Susan, Babuna and Nakhuna) in the management of Izterabi-I-Nafsani Umoomi (Generalized Anxiety Disorder) has been designed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed patients of Izterab-i-Nafsani Umoomi.
  • Patients in age group of 18 to 65 years 3) All genders 4) Patients who are ready to sign the informed consent, follow the protocol and are willing to participate in clinical study voluntarily.

排除标准

  • Panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder.
  • Patients below 18 years and above 65 years 3) History of substance abuse: Caffeine, Alcohol, drug intoxication 4) Patient who fails to follow up 5) Patient who fails to give written consent 6) Known cases of hyperthyroidism, cardiovascular diseases, renal diseases, and liver diseases.
  • Pregnant and lactating mother.

结局指标

主要结局

Hamilton Anxiety Rating Scale (HAM-A)

时间窗: 42 Days

次要结局

  • •Vegetative manifestations (increased heart rate, diaphoresis, tremor, or dry mouth)(•Symptoms in the chest cavity (respiratory symptoms, feeling of tightness, chest pain, abdominal discomfort))

研究者

发起方
Central Council for Research in Unani Medicine CCRUM New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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