Appetite-inducing effect and safety evaluation of Habb-e-Hilteet in patients with Ḍu‘f al-Ishtihā (anorexia): An open prospective clinical trial

Abstract

Objectives: Anorexia is one among the most prevalent conditions triggering malnutrition, drastic weight loss and serious health issues in people especially older adults. Habb-e-Hilteet is commonly prescribed Unani pharmacopoeial formulation for anorexia. However, no scientific data is available as to its safety and efficacy. The current study assessed the appetite-inducing effect and safety of Habb-e-Hilteet in Ḍu‘f al-Ishtihā (anorexia) patients. Methods: An open prospective clinical trial was carried out in 95 clinically diagnosed anorexia patients of either gender (19-65 yrs old). The study was approved by Institutional ethic committee and conducted in accordance with the GCP guidelines. Habb-e-Hilteet, 1 pill (500mg) was administered orally in patients twice daily for 14 days. The safety of the formulation was assessed by important pathological and biochemical indices and monitoring adverse events. The efficacy was assessed on the basis of improvement in the Simplified Nutritional Appetite Questionnaire (SNAQ) score. Results: Out of 95 patients recruited, 78 completed the trial and 17 patients lost to follow-up. The mean age of patients was 29.8 yrs, with the majority (59.0%) being female. Overall therapeutic response was found to be 96%. A significant (P<0.05) increase in the mean SNAQ score was observed after 7 and 14 days of treatment when compared to baseline. No significant difference before and after treatment was observed in pathological and biochemical indices. No adverse events were reported during the entire study period. Conclusion: The study results indicate that Habb-e-Hilteet could be a viable treatment option for anorexia with no safety concerns. Keywords: Ḍu‘f al-Ishtihā; Buṭlān al-Shahwa; Anorexia; Habb-e-Hilteet; Unani pharmacopoeal formulation.