Clinical Use of Drakshwaleha, an ayurvedic medicine in the treatment anemia due to iron deficiency.

Phase 4

• Conditions: Health Condition 1: D508- Other iron deficiency anemias

• Registration Number: CTRI/2018/08/015146
• Lead Sponsor: Central Council For Research In Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of either sex aged between18 to 50 years.

2. IDA documented by hematologic indices.

i. Hb 8gm-10gm. %

ii. S.Ferritin < 12 ng /mL

iii. TIBC >450mcg/dL

iv. S.Iron <60μg/dL for male; <50 μg/dL for female

v. MCV <80fL/redcell

vi. RDW >46fL

vii. Reticulocyte count <0.5%

(Among these the first 3 are the essential criteria for inclusion)

3. Willing and able to participate for 112 days.

Exclusion Criteria

1. Iron deficiency likely or definitely due to blood loss from the intestine or other sites.

2. History or evidence of intestinal malabsorption

3. Patients suffering from major systemic illness necessitating long term drug

treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding

disorders, etc.)

4. Other causes of Anemia (sickle cell disease, thalassemia, other hemolyticAnemia,

bone marrow failure, etc.) apparent by history, physical examination, and/or

laboratory tests.

5. Patients on prolonged ( > 6 weeks) medication with corticosteroids,

antidepressants,anticholinergics, etc. or any other drugs that may have an influence

on the outcome of the study.

6. Patients with concurrent serious hepatic disorder (defined as Aspartate

AminoTransferase (AST) and / or Alanine Amino Transferase (ALT), Total

Bilirubin, AlkalinePhosphatase (ALP) > 2 times upper normal limit), or Renal

Disorders (defined as S. Creatinine >1.2mg/dL), Total Serum Cholesterol & / or

Serum Triglycerides > 250 mg/dl, Severe PulmonaryDysfunction (uncontrolled

Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease[COPD]).

7. Alcoholics and/or drug abusers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in peripheral blood haemoglobin concentration.Timepoint: Time Frame: Every 4 weeks (on day 0, 28th,56th,84th and 112th)

Secondary Outcome Measures

Name	Time	Method
Serum Ferritin level, <br/ ><br>Serum Iron level, <br/ ><br>TIBC level, <br/ ><br>MCV level, <br/ ><br>Reticulocyte count, <br/ ><br>Red blood cell Count, <br/ ><br>Any adverse events.Timepoint: Time Frame: Every 4 weeks (on day 0, 28th,56th,84th and 112th)