Evaluation of Safety and Efficacy of a Herbo mineral Formulation for increasing Hemoglobin and Iron Deficiency Anaemia

Phase 2

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

Registration Number: CTRI/2024/03/064617

Lead Sponsor: Dabur India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Males with Haemoglobin level between 12.9 g/dL and 8 g/dL 12.9 g/dL and = 8 g/dL

Females with Haemoglobin level between 11.9 g/dL. and 8 g/dL 11.9 g/dL and = 8 g/dL

Serum Calcium levels less than 8.5 mg/dl 8.5 mg/dl

Not Taking any Iron or nutraceutical supplements currently or within 3 | months

Subjects with Reported Intolerance to oral iron supplementation like constipation/ diarrhoea/eructation/ abdominal pain/nausea

Females with regular heavier than normal menstrual periods Clinical symptoms of Anaemia, Low calcium levels

Non pregnant & non lactating females

Exclusion Criteria

Haemoglobin level less than 8 g/dL In either sex

Females with Irregular heavier than normal menstrual periods IDA with any associated complication

Participants who in Investigators opinion will not be able to follow study procedures. Any other type of Anaemia except IDA Prescence of any medical condition Thalassaemia, Diabetes, Hyperterision, Planning to get pregnant in near future. Patients who have a known history of severe cardiovascular disease.

Patients with concurrent serious Hepatic dysfunction or Renal Dysfunction l or other concurrent severe disease.

Patients who have completed participation in any other clinical trial during the last 6 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in haemoglobin levels from baseline to end of study. <br/ ><br> <br/ ><br>Change in Clinical Features Signs and Symptoms of Iron Deficiency and AnaemiaTimepoint: Change in haemoglobin levels from baseline to end of study. <br/ ><br> <br/ ><br>Change in Clinical Features Signs and Symptoms of Iron Deficiency and Anaemia

Secondary Outcome Measures

Name	Time	Method
1. Change in CBC & ESR Levels (CBC will include <br/ ><br> <br/ ><br>2. Change in Serum Iron levels basis-below-studies from baseline to end of study <br/ ><br> <br/ ><br>a. Serum Iron, <br/ ><br> <br/ ><br>3. Change in serum calcium levels. <br/ ><br> <br/ ><br>4. Changes In Ultrasound guided BMD (Request views on number of <br/ ><br> <br/ ><br>54 subjects) Change in C Reactive Protein <br/ ><br> <br/ ><br>6. Change in clinical-symptoms features of low calcium. <br/ ><br> <br/ ><br>7. Microcytic hypochromic anaemla on peripheral bloodTimepoint: 90 days