To evaluate the clinical efficacy of an Ayurvedic compound â??Drakshadi Lehaâ?? in the Management of Iron Deficiency Anemia in children.

Phase 2

Conditions: Health Condition 1: E638- Other specified nutritional deficiencies

Registration Number: CTRI/2019/05/018911

Lead Sponsor: ational Institute of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Subjects aged between 6-12 years

2. Subjects with iron deficiency anemia (Hb. 7 gm% -11.9 gm %).

3. Subjects whose parents are willing to give consent for clinical trial.

Exclusion Criteria

1. Hemoglobin <7gm/dl.

2. Subjects suffering from major systemic illness necessitating long term treatment.

3. Subjects with evidence of malignancy.

4. Subjects 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), uncontrolled pulmonary dysfunction (asthmatic and COPD patients)

5. Co-morbidity like TB, UTI and bleeding disorders etc.

6. H/o hypersensitivity to any of the trial drug or their ingredients.

7. Subjects who have completed participation in any other clinical trial during the past six months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the subjective parameters of Iron Deficiency Anemia(Pandu) in Children. <br/ ><br>1. Vaivarnya (pallor) <br/ ><br>2. Aruchi (anorexia) <br/ ><br>3. Daurbalyata (weakness) <br/ ><br>4. Shrama (fatigueness) <br/ ><br>5. Shvasha (dyspnoea) <br/ ><br>6. Kopana (irritability) <br/ ><br>7. Hridaya spandana (palpitation) <br/ ><br>8. Shotha (oedema) <br/ ><br>9. Karnakshveda (tinnitus) <br/ ><br>10. Hatanala (indigestion) <br/ ><br>11. Bhrama (giddiness) <br/ ><br>12. SpleenomegalyTimepoint: 8 weeks

Secondary Outcome Measures