Efficacy and safety of a ready-to-serve beverage derived from sharbat-e-gudhal (a traditional syrup of China rose-unani formula used in faqrud dam [anemia]) in the management of mild iron-deficiency anaemia: a randomized controlled trial
Anaemia
Recruited patients will be asked to visit the clinic periodically as the instructions given by the principal investigator (3 weeks after the first visit, with completion of the first month and monthly thereafter). Participants will be assigned to test groups I and II and the control group as described below. Group I: 150 ml of RTS beverage from sharbat-e-gudhal given at 10:00 am as a snack Group II: Sharbat-e-gudhal given as 25 ml in the morning and 25 ml at night before meals Control group: one tablet of ferrous sulphate (200 mg) with one tablet of vitamin C (100 mg) at night 2 hours before dinner Randomization will be done using computer-generated random numbers that are obtained using Research Randomizer. Duration of protocol therapy: 120 days The patients will be assessed subjectively and by objective parameters on days 0 (baseline), 21, 90, and 120. On these days a questionnaire will be administered to them by the investigators to collect data on their views regarding the improvement of symptoms on treatment and to detect any adverse effects of the treatment. Further, a blood sample (5 ml) will be taken for the required analysis by a qualified phlebotomist (nurse/medical lab technician). The blood tests will be performed at an accredited laboratory
1. Mild anaemic patients 2. Either sex 3. Aged 18 to 65 years 4. Patients with confirmed mild iron deficiency anaemia with the following limits: 4.1. Hb%: female: ≥9 g/dl and ≤12 g/dl; male: ≥9 g/dl and ≤13 g/dl 4.2. Serum ferritin: ≤30 µg/l
1. Patients below 18 years and above 65 years of age 2. Moderate to severe anaemia (Hb%: ≤9 g/dl) 3. Patient with concurrent respiratory diseases, cardiovascular diseases, liver diseases and renal diseases 4. Pregnant and lactating women 5. Patients with a history of diabetes mellitus