Clinical Study to assess the Tolerability, Treatment adherence, and safety of Drakshavaleha in Iron Deficiency Anemia

Recruitment & Eligibility

Inclusion Criteria

Subjects of any gender aged 18-60 years and diagnosed with IDA

Mean corpuscular volume (MCV) below 80 fl.

Hemoglobin 8-10.9 gm/dl (as per WHO)

Willing to provide written informed consent

Exclusion Criteria

Iron deficiency due to blood loss from the intestine or other sites.

Other causes of anemia, apart from iron deficiency, apparent by history, physical

examination, and/or laboratory tests.

Iron deficiency anemia necessitating parenteral iron therapy

Diabetic participants having FBS value 126 mg/dL or above

Intake of Iron supplements for three months before the initiation of the study.

Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of

the upper normal limit)

Participants with Renal Dysfunction (defined as S. creatinine >1.2 mg/dl);

History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular

disease, psychiatric illness, tuberculosis, HIV, malignancy, etc.

Patients suffering from major systemic illnesses necessitating long-term treatment

(Psycho-neuro-endocrinal disorders, etc.)

Hormone therapy (including the use of androgens/anabolic steroids) or administration

of drugs that affect erythropoiesis, less than three months before the start of the study.

Female participants who are pregnant, intend to become pregnant, are breastfeeding,

or not willing to use effective contraceptive precautions during the study.

History or active substance abuse

History of hypersensitivity to the trial interventions or their ingredients.

Any other condition that in the opinion of the investigator may compromise the

participant’s safety or compliance

Primary Outcome Measures

Name	Time	Method
Assessment of the tolerability of the Ayurvedic intervention through reported <br/ ><br>incidence of treatment-emergent adverse events and serious adverse events during the <br/ ><br>study period [ Time Frame: Baseline to day 90] <br/ ><br>? Assessment of treatment adherence through self-reported compliance log and used <br/ ><br>medication containers/strips.Timepoint: Assessment of the tolerability of the Ayurvedic intervention through reported <br/ ><br>incidence of treatment-emergent adverse events and serious adverse events during the <br/ ><br>study period [ Time Frame: Baseline to day 90] <br/ ><br>? Assessment of treatment adherence through self-reported compliance log and used <br/ ><br>medication containers/strips.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who withdrew/dropped out from the study due to adverse <br/ ><br>events and/or poor tolerability <br/ ><br>Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) [Time <br/ ><br>frame: Baseline, 90 th day] <br/ ><br>Mean change in Hemoglobin% from baseline <br/ ><br>Change in haematological parameters (total RBC count, RBCs indices & Absolute <br/ ><br>Reticulocyte count) from baseline [Time frame: Baseline, 90 th day] <br/ ><br>Changes in parameters of Iron profile (Serum Iron, ferritin & transferrin saturation <br/ ><br>levels) from baseline [Time frame: Baseline, 90 th day] <br/ ><br>Proportion of participants who attained Hb% within the mild range (defined as Hb 11- <br/ ><br>11.9 g/dl as per WHO) [Time frame: Baseline, 30 th day, 60 th day, 90 th day] <br/ ><br>Change in fatigue levels from baseline assessed through Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scaleTimepoint: Baseline, 30 th day, 60 th day, 90 th day]