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Comparison of effect of adding Drakshavaleha to iron tablets in women with low Hemoglobin levels

Evaluation of Efficacy and Safety of Integrative Therapy of Drakshavaleha with Oral Iron Folic Acid Supplements in Management of Mild to Moderate Iron Deficiency Anaemia: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067169
Enrollment
210
Registered
2024-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Women of reproductive age group (18 to 49 years) with mild (Hb 11-11.9) to moderate (Hb 8 to 10.9 g/dL) anemia 2 Serum ferritin less than 30 mcg/dL 3 Should consent to receive any type of intervention before randomization. 4 Not participating in any other research study

Exclusion criteria

Exclusion criteria: 1 Pregnant and lactating women 2 Known cases of anemia due to other causes (Sickle cell anemia; Thalassemia minor) 3 Those who are already consuming IFA greater than 14 days 4 HbA1C greater than 6.5% 5 Known Diabetics on regular medicines 6 Known allergy to iron and ingredients of Drakshavaleha 7 Patient with known chronic kidney and liver disease 8 Any other condition in the advice of the treating doctor that is putting the participant on risk due to study participation

Design outcomes

Primary

MeasureTime frame
Hb levelTimepoint: Baseline 1 month 2 months 3 months

Secondary

MeasureTime frame
Serum iron Total Iron binding capacity Ferritin Transferrin saturation RBC MCV MCH MCHCTimepoint: Baseline 1 month 2 months 3 months;quality-of-life score using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scaleTimepoint: Baseline 3 months

Countries

India

Contacts

Public ContactDr Manish Barvaliya

ICMR National Institute of Traditional Medicine

barvaliya.m@icmr.gov.in9726901845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026