Evaluation of efficacy and tolerability of select Ayurveda formulations in moderate Iron Deficiency Anemia

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

i.Participants of age between 18 to 55 years of any sex.

ii.Hemoglobin ranging between 8 to 10.9 gm/dl

iii.Hematocrit less than 41% in men and less than 36% in women

iv.Mean corpuscular volume less than 80%

v.Willing to provide informed written consent for participation in the study

Exclusion Criteria

i.Recent history of severe acute or chronic blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, surgery, trauma, etc.

ii.Participants suffering from megaloblastic anemia (pernicious anemia) (Serum Vit. B12 <150 pg/ml) or Hypothyroidism (TSH >10 mIU/L)

iii.Patients already on iron supplements at present or during the last 3 months

iv.Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD) (CAGE score >2), anaemia due to chronic disease and medications, Thalassemia, Sideroblastic anemia, sickle cell, cold hemoglobinuria (Donath-Landsteiner hemolytic anemia), cold agglutinin disease (cold antibody hemolytic anemia), and other hemolytic anemias disseminated intravascular coagulation (DIC), Bone marrow suppression (aplastic anemia and myelophthisic anemia), Myelodysplastic syndromes, mechanical heart valves, hemolytic uremic syndrome (HUS), etc.

v. Known case of other major co-morbidities like chronic cardiac/ pulmonary diseases, malignancy, etc.

vi.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl)

vii.Patients on prolonged ( > 6 weeks) medication (steroids, immune-suppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study

viii. Pregnant women or women who are planning for conception or lactating mothers

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin level as compare to standard of care.Timepoint: at baseline, and at the end of 12th week

Secondary Outcome Measures

Name	Time	Method
i.Proportion of participants achieving a hemoglobin increase of =2 g dL <br/ ><br>ii. Change in a score of FACIT –Fatigue scale disease-specific symptoms ] <br/ ><br>iii. Change in a score of the Epworth sleepiness scale <br/ ><br>iv. Change in VAS score of general weakness, dizziness, palpitation <br/ ><br>v.Change in biochemical parameters <br/ ><br>vi. Occurrence of adverse events in both groups <br/ ><br>vii. Comparison of Number and reasons of loss to follow-ups in both groups <br/ ><br>viii. Compliance of interventions in both groups <br/ ><br>Timepoint: i.Proportion of participants achieving a hemoglobin increase of =2 g dL-1 at any time from Baseline to Week 12 in both groups <br/ ><br>ii. Change in a score of FACIT [baseline,4th,8th,12th, and 16th week] <br/ ><br>iii. Change in the score of Epworth sleepiness scale [baseline,4th,8th,12th, and 16th week] <br/ ><br>iv. Change in VAS score of general weakness, dizziness, palpitation [baseline,4th,8th,12th, and 16th week] <br/ ><br>

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