Effect of Unani formulation on iron deficiency anemia in women of reproductive age: A prospective randomized controlled trial

• Assessed efficacy of Sharbat Anar Shireen in managing Iron Deficiency Anemia (IDA) in reproductive-age women • Demonstrated significant improvement in fatigue, pallor, Hb levels, and exercise capacity observed • Superior efficacy to elemental iron in improving clinical and haematological parameters • Demonstrated safety and tolerability with no notable adverse effects in treatment group • Reinforces Unani medicine’s role in holistic, evidence-based anaemia management Iron Deficiency Anemia (IDA) ranks among the most prevalent nutritional disorders, particularly affecting adolescents and women of reproductive age. An estimated 2 billion individuals worldwide suffer from iron deficiency. Globally, iron deficiency is responsible for around 50% of all anemia cases and contributes to approximately 841,000 deaths each year. This study aims to evaluate the effect of Unani formulation for treating IDA in reproductive age group women. This clinical trial was a single-blind, randomized, standard-controlled study involving 30 women aged 18 to 45 years, all of whom completed the trial. The Institutional Ethics Committee approved this study, and it was registered with the Clinical Trials Registry-India. Participants were randomized between two groups of 15 each using block randomization, receiving either 20ml Sharbat Anar Shireen (Juice of Punica granatum. Linn) (test group) or elemental iron 100 mg (control group) once daily after food with water for 30 days. The primary outcomes were evaluated using the Fatigue Severity Scale, Grading of Pallor, and the Exercise Capacity Evaluation Questionnaire, assessed at baseline and at fortnightly follow-ups. The secondary outcome included changes in haemoglobin percentage, measured before and after treatment. An additional follow-up was conducted one-month post-treatment to assess sustained effects. Safety assessments were evaluated through routine clinical evaluations and monitoring of adverse effects. This study demonstrated the significant effect of Sharbat Anar Shireen (Punica granatum. Linn), a Unani formulation in improving both subjective and objective parameters. After one month of treatment, both groups demonstrated statistically significant improvements ( P < 0.001) in the Fatigue Severity Scale, Pallor Grading, and Exercise Capacity Evaluation Questionnaire at every assessment point. Intergroup analysis exhibited no significant differences ( P > 0.05), except for enhanced exercise capacity and reduced fatigue, which showed a statistically significant improvement in the test group compared to the control group ( P < 0.05). Objective parameters, including haemoglobin percentage, significantly improved in both groups after treatment ( P < 0.001) with intergroup analysis revealed a statistically significant difference ( P < 0.005). This RCT demonstrated that Sharbat Anar Shireen (Punica granatum. Linn) is a safe and effective intervention for iron deficiency anemia. Both groups exhibited significant improvements ( P < 0.001), with the test group exhibiting greater efficacy in reducing fatigue and improving haemoglobin levels ( P < 0.005). Further clinical studies are warranted to confirm these findings.