Punarnavadi Mandura vs Punarnavadi Mandura-Drakshavaleha vs Iron Folic Acid (IFA) in Iron deficiency anemia among non-pregnant women of reproductive age group

Efficacy and safety of Punarnavadi Mandura alone and in combination with Drakshavaleha compared to iron folic acid in the treatment of moderate iron deficiency anaemia among non-pregnant women of reproductive age group: a community-based three arm multicentre randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060271

Enrollment

3912

Registered

2023-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 2: E611- Iron deficiency

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Non-pregnant, non-lactating women of age group 18 to 49 years 2. Haemoglobin level 8 to 10.9 gm/dl 3. Serum Ferritin less than 15 µg /L 4. Women who are willing to use a reliable method of contraceptive to avoid pregnancy for next 6 months. 5. Women not planning to move residence/migrate within the next 6 months

Exclusion criteria

Exclusion criteria: 1. Known case of any other forms of anaemia 2. Any acute illness within last 14 days 3. Women having attained menopause or reporting symptoms suggestive of menopause 4. Women with known case of diabetes mellitus orHbA1c more than 6.5 percent 5. Known allergy to iron and related products 6. Women with known liver and kidney disorders

Design outcomes

Primary

Measure	Time frame
Change in mean hemoglobin at the end of intervention of 90 days among non-pregnant moderately anaemic (Hb: 8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Purnarnavadi Mandura alone or Purnarnavadi Mandura in combination to Drakshavaleha, or Ferrous Sulphate and folic acid combination.Timepoint: Baseline, 90 days and 180 days	—

Secondary

Measure	Time frame
1. Change in mean hemoglobin, haematological parameters (haematocrit, MCV, MCH & MCHC) & Iron indices (TIBC, Serum Iron, transferrin saturation & serum ferritin) at the end of 90 days of treatment & at 180 days follow up from baseline.in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone with those receiving Punarnavadi Mandura in combination with Drakshavaleha. 2. Compare the safety (incidence of adverse events) & change in quality of life score using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at the end of 90 days of treatment & at 180 days follow up from baseline in two intervention arms with active control arm.Timepoint: 90 & 180 days from baseline	—

Measure

Time frame

1. Change in mean hemoglobin, haematological parameters (haematocrit, MCV, MCH & MCHC) & Iron indices (TIBC, Serum Iron, transferrin saturation & serum ferritin) at the end of 90 days of treatment & at 180 days follow up from baseline.in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone with those receiving Punarnavadi Mandura in combination with Drakshavaleha. 2. Compare the safety (incidence of adverse events) & change in quality of life score using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at the end of 90 days of treatment & at 180 days follow up from baseline in two intervention arms with active control arm.Timepoint: 90 & 180 days from baseline

—

Countries

India

Contacts

Public ContactDr Tanu Anand

Indian Council of Medical Research

tanu.anand@icmr.gov.in9811028964

Outcome results