MedPath

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

Phase 2
Conditions
Health Condition 1: D539- Nutritional anemia, unspecified
Registration Number
CTRI/2023/10/059046
Lead Sponsor
ational Research Institute of Unani Medicine for Skin Disorders.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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% & <13gm%

Female, >7.0 gm% & < 12.0gm%

Exclusion Criteria

The following patients will be excluded from the study:

1 Participants aged <18years and >60years of age.

2 Participants with haemoglobin < 8.0 & >13 gm% in Males where as <7.0

& >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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Hb(gm/dl) at 12 weeks from base lineTimepoint: 84 days
Secondary Outcome Measures
NameTimeMethod
1) Improvement in signs & symptoms <br/ ><br>2) Change in Reticulocyte Count, S.Ferritin level, RBC Count, PCV, MCV, <br/ ><br>MCH,MCHC.Timepoint: 84 days
© Copyright 2025. All Rights Reserved by MedPath