The Efficacy of Unani Formulation Consisting of Phoenix dactylifera Fruit, Trigonella foenum-graecum Seeds, and Honey in Qillat-e-Mani (Oligospermia) – A Single-Arm Clinical Trial

Abstract

Background and objective: Qillat-e-Mani (oligospermia) is a very common health problem that significantly impairs the patients' quality of life, resulting in family separation, depression, and anxiety. It has extensively been discussed in Unani medicine, with the greater emphasis on its therapeutic as well as dietary interventions. Thus, the purpose of this study was to determine the efficacy of a Unani formulation in patients with oligospermia. Methods: It was a single-arm clinical trial conducted on 30 eligible participants in the age bracket of 20 to 60 years suffering from laboratory-confirmed oligospermia, after obtaining written informed consent. The trial intervention consisted of a 6g daily dose of Unani formulation in M'ajūn (semi-solid paste) form. The efficacy of the intervention was determined by assessing sperm count, motility, morphology, and volume from baseline to the conclusion of the therapy. The paired t-test was used to analyze the data. Results: The objective parameters showed statistically significant improvements without the occurrence of any adverse events. Conclusion: Although the Unani formulation is statistically effective in treating Qillat-e-Mani (oligospermia), it failed to normalize the range of sperm counts in many patients, which may be attributed to the brief duration of therapy. Thus, longer-term RCTs with more stringent criteria are required to bolster the scientific evidence.