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

Phase 3

• Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecified

• Registration Number: CTRI/2022/06/043305
• Lead Sponsor: Central Council for Research In Ayurvedic Sciences CCRASMinistry Of Ayush Govt Of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 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