Efficacy and safety of a polyherbal Unani formulation in mixed anxiety and depressive disorders – A prospective clinical trial

• Polyherbal formulation found effective in treating Mixed Anxiety Depressive Disorder (MADD) • Marked improvement in HAM-A and HAM-D scores observed after 6 weeks of therapy • 19.73% patients achieved complete relief; 55.26% had significant relief; 25.00% experienced partial relief from MADD • No significant lab abnormalities reported, indicating good safety and tolerability • Findings validate Unani medicine's integration in mental health care management Mixed Anxiety Depressive Disorder (MADD) is a prevalent mental health condition affecting overall well-being. Unani medicine offers therapeutic interventions, including Majoon Najah, a polyherbal Unani pharmacopoeial formulation with potential anxiolytic and antidepressant properties. Majoon Najah contains several medicinal plants known for their neuroprotective and mood-stabilizing effects, including Terminalia chebula Retz. (Post-e-Halela Kabli), Terminalia bellerica Roxb. (Post-e-Balela), Emblica officinalis Gaertn. (Aamla), and Cuscuta reflexa Roxb. (Aftimoon) etc. This study aimed to evaluate the safety and efficacy of Majoon Najah in patients diagnosed with MADD. A prospective open-label, single-arm before-after study was conducted at the Regional Research Institute of Unani Medicine, Chennai, India. A total of 76 patients aged 18–60 years with MADD were enrolled. The study was approved by the Institutional Ethics Committee on 18 July 2019 and registered with CTRI on 02 February 2020. Participants received polyherbal Unani formulation 5gm orally twice daily with water for 6 weeks . Efficacy was assessed using the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Depression Rating Scale (HAM-D) at baseline and follow-ups. Safety was evaluated through laboratory investigations. Statistical analysis used repeated-measures ANOVA ( P <0.05). The results revealed that significant reductions were observed in HAM-A (27.43 ± 8.16 to 6.92 ± 4.26) and HAM-D scores (20.53 ± 5.40 to 5.52 ± 3.38) ( P <0.05). No significant biochemical or haematological changes were noted ( P >0.05). Treatment response analysis showed 19.73% of participants achieved complete relief, 55.26% showed significant relief, and 25% showed partial relief. This finding inferred that polyherbal Unani formulation, Majoon Najah is a safe and effective intervention for reducing anxiety and depression symptoms without adverse effects, supporting its safe therapeutic use in Unani medicine for managing MADD. The study was subsequently registered with the Clinical trial Registry-India (CTRI) with CTRI number CTRI/2020/02/023429.