Therapeutic evaluation of herbal drug Paeonia officinalis in the management of generalized anxiety disorder – A single blind randomized placebo controlled trial

Generalized Anxiety Disorder (GAD) is a prevalent psychiatric condition characterized by persistent and excessive worry, often accompanied by physical symptoms such as restlessness, fatigue, and difficulty concentrating. Conventional treatments, including benzodiazepines and selective serotonin reuptake inhibitors (SSRIs), have limitations such as side effects and dependence potential. Unani medicine offers herbal alternatives with promising therapeutic potential. Ood saleeb (Paeonia officinalis) has been historically used for neurological and psychological disorders, but its efficacy in GAD remains underexplored. A single blind randomized placebo-controlled trial was conducted involving participants diagnosed with GAD based on DSM-5 criteria. Patients were divided into two groups: one receiving Ood saleeb and the other receiving a placebo treatment. Grading of anxiety was done using the Hamilton Anxiety Rating Scale (HAM-A) at baseline, 15th, 30th,45th, and 60th day. Secondary outcomes included Restlessness, Insomnia, Palpitations, Fatigue and Irritability. Data were analyzed using appropriate statistical methods to determine efficacy. Ood saleeb significantly reduced HAM-A scores compared to placebo, demonstrating notable anxiolytic effects. Improvements in subjective parameters were observed in the treatment group. No severe adverse effects were reported, suggesting a good safety profile. The findings indicate that Ood saleeb may offer a natural alternative for managing GAD with minimal side effects. Ood saleeb (Paeonia officinalis) exhibited significant anxiolytic properties in patients with GAD, supporting its potential as a complementary or alternative treatment in Unani medicine. Further large-scale studies are recommended to validate these findings.