Clinical study of Ayurvedic intervention – Punarnavadi Mandura in treating Iron Deficiency Anemia.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

2.Mean corpuscular volume (MCV) below 80 fl.

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

4.Willing to provide written informed consent

Exclusion Criteria

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

2.Other causes of anemia, apart from iron deficiency, apparent by history, physical examination, and/or laboratory tests.

3.Iron deficiency anemia necessitating parenteral iron therapy

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

5.Participants with Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit)

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

7.History of uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease, psychiatric illness, tuberculosis, HIV, malignancy, etc.

8.Patients suffering from major systemic illnesses necessitating long-term treatment (Psycho-neuro-endocrinal disorders, etc.)

9.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.

10.Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study.

11.History or active substance abuse

12.History of hypersensitivity to the trial interventions or their ingredients.

13.Any other condition that in the opinion of the investigator may compromise the participant’s safety or compliance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assessment of the tolerability of the Ayurvedic intervention through reported incidence of treatment-emergent adverse events and serious adverse events during the study period [ Time Frame: [Baseline to day 90] <br/ ><br>2.Assessment of treatment adherence through self-reported compliance log and used medication containers/strips. [Time frame: Baseline, 30th day, 60th day, 90th day] <br/ ><br>Timepoint: Baseline, 30th day, 60th day, 90th day] <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Proportion of participants who withdrew/dropped out from the study due to adverse <br/ ><br>events and/or poor tolerability <br/ ><br>2. Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) <br/ ><br>3. Mean change in Hemoglobin% from Baseline <br/ ><br>4. Change in haematological parameters (total RBC count, RBCs indices & Absolute <br/ ><br>Reticulocyte count) from baseline <br/ ><br>5. Changes in parameters of Iron profile (Serum Iron, TIBC, ferritin & transferrin <br/ ><br>saturation levels) from baseline <br/ ><br>6. Proportion of participants who attained Hb% within the mild range (defined as Hb 11- <br/ ><br>11.9 g/dl as per WHO) <br/ ><br>7. Change in fatigue levels from baseline assessed through Functional Assessment of <br/ ><br>Chronic Illness Therapy-Fatigue (FACIT-F) scaleTimepoint: [Baseline, end of 30th day, end of 60th day, end of 90th day] <br/ ><br>