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To test which of the two drugs; Ayurvedic (Punarnava Mandoor) and Allopathic (Iron and folic acid) is better for the treatment of anaemia among women of child bearing age group

Randomised Controlled Trial to Study the Adherence and Efficacy of Ayurvedic Medicine Compared to Allopathic Medicine for Treatment of Iron Deficiency Anaemia among Women of Reproductive Age Group in Villages of Haryana - RCT_AIFA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019612
Enrollment
260
Registered
2019-06-11
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: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Punarnava Mandoor tablet: phase 1: 1 tablet BD for 3 months phase 2: 1 tablet BD for 6 months Control Intervention1: Iron folic acid supplement (ferrous sulphate 100 mg elemental iron

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: phase 1 1. Women of the age group 15 to 45 years. 2. Women with haemoglobin level 8 to 11.9 gm/dl. 3. Non- pregnant women. 4. Women who have adopted family planning methods (temporary/permanent) and are not planning pregnancy within next one year phase 2 1. Pregnant women with haemoglobin level between 7 to 9.9 g/dl 2. Uncomplicated pregnancy

Exclusion criteria

Exclusion criteria: phase 1 1. Women below 15 years and above 45 years of age. 2. Pregnant women. 3. Non-anaemic women. 4. Women with haemoglobin level below 8 gm/dl. 5. Women planning for pregnancy within next one year. 6. Women with known chronic ailments like diabetes mellitus, hypertension, renal ailments, liver disorders, chronic infections. phase 2 1. Pregnant women with haemoglobin level less than 7g/dl. 2. Pregnant women with haemoglobin level less than/equal to 10g/dl. 3. Complicated pregnancies. i.e. Pregnant women with any history of Ante partum haemorrhage, prolonged bleeding, bleeding piles or bleeding from any other site. Pre-eclampsia, eclampsia, diabetes, hypertension; infections like tuberculosis, hepatitis, HIV. Previous history of post-partum haemorrhage, preterm labour, two or more miscarriages, stillbirth, neonatal death, birth with congenital abnormality, infant with Rh-isoimmunisation or ABO incompatibility.

Design outcomes

Primary

MeasureTime frame
Improved adherence to medication Timepoint: phase 1: 3 months phase 2: till hb level reaches 10gm/dl or more; or 6 months (whichever is earlier)—

Secondary

MeasureTime frame
Improvement in haemoglobin. Improvement in serum iron, ferritin, TIBC, percent saturationTimepoint: phase 1: 3 months phase 2: till hb level reaches 10gm/dl or more; or 6 months (whichever is earlier)—

Countries

India

Contacts

Public ContactDr Jyoti Hudia

Postgraduate Institute of Medical Education and Research

aggak63@gmail.com01722755218

Outcome results

None listed

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