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

Evaluation of Safety and Efficacy of An Ayurceutical Formulation DRDC/2023/044 for Haemoglobin Levels and Iron Deficiency Anaemia - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064617

Enrollment

Registered

2024-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in haemoglobin levels from baseline to end of study. Change in Clinical Features Signs and Symptoms of Iron Deficiency and AnaemiaTimepoint: Change in haemoglobin levels from baseline to end of study. Change in Clinical Features Signs and Symptoms of Iron Deficiency and Anaemia	—

Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr KIran M Goud

Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Center

kiranmgoud@yahoo.co.in9845109556

Outcome results