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A clinical study to see the effect of some Ayurvedic formulations in the treatment of Anaemia

Clinical Evaluation of Punarnavadi Madura and Dadimadi Ghrita in the Management of Iron Deficiency Anaemia - ACT- IDA-2010

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002335
Enrollment
150
Registered
2012-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Iron Deficiency Anaemia

Interventions

Intervention1: Punarnavadi Mandura: Dose â?? 500 mg twice daily Dosage form - tablet of 250 mg Route of Administration â?? oral Time of Administration-Twice a day before food Anupana-Lukewarm Water

Sponsors

Department of AYUSH Ministry of Health Family Welfare Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of either sex aged between 10 to 14 years 2. Children with iron deficiency anemia (Hb 8gm-10gm.%), 3. Willing and able to participate for 16 weeks. (Assent to be obtained from Parent(s) / Guardian(s).

Exclusion criteria

Exclusion criteria: 1. Children suffering from major systemic illness necessitating long term drug treatment. 2. Children with evidence of malignancy. 3. Children 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) 4. Co-morbidities like Tuberculosis, Chronic urinary tract infection, Bleeding disorders etc. 5. H/o hypersensitivity to any of the trial drugs or their ingredients. 6. Children who have completed participation in any other clinical trial during the past six (06) months. 7. Any other condition which the P.I. thinks may jeopardize the study

Design outcomes

Primary

MeasureTime frame
Change in Hb%Timepoint: At baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks.

Secondary

MeasureTime frame
1.Symptomatic relief. 2. Change in Serum ferritin level. 3. Change in Peripheral Blood Smear Picture.Timepoint: 1.Symptomatic relief. At baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks. 2. Change in Serum ferritin level. At Baseline, 42nd day and 84th day. 3. Change in Peripheral Blood Smear Picture. At Baseline, 42nd day and 84th day.

Countries

India

Contacts

Public ContactDr Pradeep Dua

Central Council for Research in Ayurvedic Sciences (CCRAS)

duadrpradeep@gmail.com011-28525831

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026