Generalised Anxiety Disorder is a common anxiety disorder, the essential feature of which is a pattern of  chronic persistent anxiety. It can be characterized by excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities (such as work or school performance). Associated with 3 or more of the following six symptoms (with at least some symptoms present for more days than not for the past 6 months):

1)    Restlessness or feeling keyed up or on edge.

2)    Being easily fatigued

3)    Difficulty in concentration or mind going blank

4)    Irritability

5)    Muscle tension

6)    Sleep disturbance

 The above symptoms cause clinically significant distress often physical complaints like dizziness, tachycardia, tightness of chest, sweating, tremor or impairment in social, occupational or other important areas of functioning.

The Global prevalence of anxiety disorders in 2019 was 4.05%. Globally, the estimated newly-diagnosed anxiety disorder patients increased from 194.9 million in 1990 to 301.4 million in 2019, and persisted to rise to 374 million in 2020 due to COVID–19 pandemic. The current weighted prevalence of Generalised Anxiety Disorder (GAD) is 0.57%. One year prevalence rate of Generalised Anxiety Disorder is 3% and lifetime prevalence rate is 5-6%.

Izterab-i-Nafsani Umumi is the unani translation for Generalised Anxiety Disorder (GAD), incorporating the Arabic term Izterab for anxiety in unani texts, and the addition of Nafsani to denote its psychological aspect. Literally, Izterab-i-Nafsani stands for worry, excessive thinking, fear and hinderance in routine work. In Unani literature, the term  Malankhuliya (Melancholia) is commonly used for depression. Melancholia is one of the often used words of psychiatry, while depression is the recent name of Melancholia. Hippocrates (460-357 BC) described melancholia as a state of aversion to food, despondency, sleeplessness, irritability and restlessness. It is defined as a disease in which there is derangement of thoughts and intellect. The disease has been described to be caused mainly due to disproportionate (excessive) accumulation of black bile or deterioration in its quality. The symptoms of Malankhuliya as described in Unani literature are: withdrawal from the society, negative thoughts and feelings, excessive grief, feeling of worthlessness, fear for no reason, nervous exhaustion, sleeplessness, restlessness, loss of interest and enjoyment, fatigue and loss of energy, palpitation etc. 

Thus, from the above literature, it can be concluded that the symptoms of Malankhuliya have similarity with the symptoms of anxiety and depression described in DSM-V. in which the mental functions of the individual are deranged due to disproportionate (excessive) accumulation of black bile or deterioration in its quality. Therefore, in order to treat the same, an important polyherbal pharmacopoeial preparation of Unani system of medicine viz. Majun Najah is selected for the present study, as it possesses Mundij-i-Sawda (concoctive of black bile) and Mushil-i-Sawda (purgative of black bile) properties which are mainly responsible to ameliorate the diseased condition by removing the causative factor or improving its quality.

Modern management includes a combination of psychological (family education, reassurance, deep muscle relaxation and cognitive behaviour therapy), pharmacological (Selective Serotonin Reuptake Inhibitors, Selective Norepinephrine Reuptake Inhibitors, Tricyclic antidepressants, Benzodiazepines, Buspirone and Beta blockers) and psychosocial intervention. Patients taking pharmacotherapy have side effects like sedation, indigestion, headache, nausea, dry mouth, weight gain, etc. and are also at risk for developing withdrawal symptoms.

Considering the significant prevalence of Generalised Anxiety Disorder and the side effects linked to pharmacotherapy in the allopathic system of medicine, efforts are being made to find safer and more effective treatments for Generalised Anxiety Disorder. A pre-clinical study of Majun Najah  conducted at National Institute of Unani Medicine, Bangalore (December 2016)  and National Research Institute of Unani Medicine, Hyderabad (March 2020) demonstrated significant, dose-dependent and anxiolytic effects in animal models- surpassing or matching standard antidepressant drugs like Imipramine and desipramine (p value less than 0.05), and effectively reducing immobility in forced swim tests (p value less than 0.001) – thereby providing strong rationale for its clinical assessment in GAD.

The current clinical study is therefore designed to evaluate the therapeutic effects of Majun Najah in the management of Izterab-i-Nafsani Umumi (Generalised Anxiety Disorder).