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Clinical Study to Evaluate Safety and Efficacy of a Unani Formulation in Anaemia

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Herbomineral Unani Formulation Itrifal Fauladi in the Management of Faqr al-Dam ( Anaemia) - N/A

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059046
Enrollment
60
Registered
2023-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: D539- Nutritional anemia, unspecified

Interventions

Intervention1: Itrifal Fauladi: Dosage form:Itrifal (Semisolid) Dose: 7gm once daily Mode of administration: Oral Composition of Itrifal Fauladi : 1.Amla (Emblic officinalis) 2.Namak-e-Sang(Rock sal

Sponsors

National Research Institute of Unani Medicine for Skin Disorders.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The following participants will be included in the study: 1 Participants in the age group of 18-60 years of either gender having any of the following signs and symptoms. Pallor Weakness and Fatigue Dyspnea Palpitation Anorexia Angular Stomatitis and Glossitis Oedema Koilonychia (Spoon Shaped Nail) Dizziness Fainting 2 Heamoglobin: Male, >8.0 gm% & Female, >7.0 gm% & < 12.0gm%

Exclusion criteria

Exclusion criteria: The following patients will be excluded from the study: 1 Participants aged 60years of age. 2 Participants with haemoglobin 13 gm% in Males where as & >12.0 gm% in Female. 3 History of acute blood loss, chronic diseases requiring long term treatment. 4 Pregnant and lactating women were excluded. 5 Known case of significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction/ Malignancy/ HIV Infection /AIDS etc . 6 Known allergy to herbal drugs. 7 Those who are unwilling to come for regular follow up for the entire duration of the study.

Design outcomes

Primary

MeasureTime frame
Change in Hb(gm/dl) at 12 weeks from base lineTimepoint: 84 days

Secondary

MeasureTime frame
1) Improvement in signs & symptoms 2) Change in Reticulocyte Count, S.Ferritin level, RBC Count, PCV, MCV, MCH,MCHC.Timepoint: 84 days

Countries

India

Contacts

Public ContactDr Kahkashan Bano

National Research Institute of Unani Medicine for Skin Disorders

aarzu763@gmail.com9032519286

Outcome results

None listed

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