Clinical Study on Iron Deficiency

A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED, CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HABB I KHABATH AL HADID COMPARED WITH FERROUS SULPHATE IN THE MANAGEMENT OF FAQR AL DAM (IRON DEFICIENCY ANAEMIA) - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096507

Enrollment

Registered

2025-10-28

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: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: habbe Khabsul Hadid: Composition: Khabs-ul-Hadeed (Iron oxid) 380gm Habb-ul Rashaad (Lepidium sativum L) 80 gm Tukhm-e-Gandana 9Allium ascalonicum L) 70 gm Tukhm-e-Jirjeer (Eruca Sativa

Eligibility

Inclusion criteria

Inclusion criteria: Participants of any gender in the age group of 18-60 years Participants with Iron Deficiency Anaemia (IDA) defined for this study as moderate anaemia with Haemoglobin (Hb) levels between 8 g/dL and 10.9 g/dL and Serum Ferritin level less than 15 µg/L Participants having any of the following signs and symptoms. Pallor of Skin and Mucous Membranes Easy Fatigability Reduced Work or Exercise Capacity Dyspnoea on Exertion Palpitations Ability to understand and give informed consent for participation. Willing to come for follow up visit as per protocol requirement.

Exclusion criteria

Exclusion criteria: Participants aged less than 18 year and more than 60 years of age. Participants with Hemoglobin less than 8 g/dL and more than 10.9 g/dL Pregnant and Lactating Women Known Case Of Diabetes mellitus History of Acute Blood Loss Known Cases of Cardiovascular/ Hepatic/ Renal Disorders or chronic diseases requiring long-term treatment Known Hypersensitivity to the study drug or any of its ingredients

Design outcomes

Primary

Measure	Time frame
Change in Haemoglobin level at 56th Day from baselineTimepoint: 2nd and 4th week	—

Secondary

Measure	Time frame
Change in Serum Ferritin level at 56th day from baseline Changes in Hematological Parameters (RBC,MCV,MCH,MCHC)at 56th day from baseline Changes in Peripheral Blood Smears at 56th day from baseline Relief in Signs & Symptoms – Easy Fatigability, Reduced Work or Exercise Capacity, Dyspnoea on Exertion, Palpitation, Pallor at 56th day from baseline Evaluation of Safety by: a.Monitoring Adverse Events (AEs) b.Changes in Laboratory Parameters (performed at baseline and at week 8)Timepoint: 2nd and 4th week	—

Measure

Time frame

Change in Serum Ferritin level at 56th day from baseline Changes in Hematological Parameters (RBC,MCV,MCH,MCHC)at 56th day from baseline Changes in Peripheral Blood Smears at 56th day from baseline Relief in Signs & Symptoms – Easy Fatigability, Reduced Work or Exercise Capacity, Dyspnoea on Exertion, Palpitation, Pallor at 56th day from baseline Evaluation of Safety by: a.Monitoring Adverse Events (AEs) b.Changes in Laboratory Parameters (performed at baseline and at week 8)Timepoint: 2nd and 4th week

—

Countries

India

Contacts

Public ContactDr Shaikh Reshma Bano Mohammad Haneef

National Research Institute of Unani Medicine for Skin Disorders

qamaruddindr@gmail.com8700027178

Outcome results

None listed

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