A Randomized Clinical Trial to Test Efficacy of Chamomile and Saffron for Neuroprotective and Anti-Inflammatory Responses in Depressive Patients

Abstract

Depression is one of the common psychiatric problems in growing population caused by long-term stressful events that may trigger the down regulation of neurogenesis. The pathogenesis of depression initially relies on serotonin deficiency which is associated with depressive feelings. Tryptophan (TRP) depletion participate crucial role in inducing depressive symptoms. Long-term reduction of 5-HT may disseminate to high sensitivity of MDD and alters the level of BDNF. Some studies have also revealed the strong association between excessive neuroinflammation and BDNF levels, due the release of pro-inflammatory cytokines. The treatment approach of antidepressant with natural entities would be a safest option to mitigate the pathophysiological alterations However, the number of evidence-based on synergic effects of antidepressant with herbal agents is limited. The purpose of this study was to assess the synergistic effects of two well-known herbs, chamomile and saffron, as an adjuvant therapy in patients with mild to moderate depression. The present study was study randomized, open, blinded trial and comprised of 120 participants randomly allocated to control (n=60) and test (n=60. After consent, the patient health questionnaire- 9 (PHQ-9) was filled to obtain depression scores. The test participants were received herbal tea sachets twice a day for one month (20 mg Chamomile and 1 mg Saffron/ sachet) along with routine medicines, while control participants were received only allopathic medications. Blood samples were taken before and after the treatment. The depressive symptoms improved significantly with both treatments. The effect of herbs enhanced the efficacy of medications and significantly improved PHQ-9 scale and BDNF while reduced the inflammatory markers (CRP) and TRP level in plasma thereby increased the availability of TRP in brain. It has been concluded that the herbal adjuvant therapy produced long term improvement against depression and enhanced the efficacy of allopathic treatment.

Clinical Trial Registration Details: The study was registered with ClinicalTrials.gov. Identifier: NCT04935671.

Funding Information: The study was supported by the Higher Education Commission of Pakistan grant number 9447.

Declaration of Interests: The authors have no conflict of interests to disclose.

Ethics Approval Statement: The study was approved by the Aga Khan University's ethical review committee under the number 5011-BBS-ERC-17.

Keywords: brain derived neurotrophic factors (BDNF), Chamomile, C-reactive protein (CRP), patient health questionnaires 9 (PHQ-9), Saffron, tryptophan (TRP)