Anaemia clinical Research with Ayurvedic Drugs

Phase 2

• Conditions: Health Condition 1: null- Iron Deficiency Anaemia

• Registration Number: CTRI/2017/05/008463
• Lead Sponsor: CCRAS New Delhi

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either sex aged between 18 to 50 years.

2.Patients with iron deficiency anaemia (Hb 6gm-10gm),

3.S. Ferritin < 30 μg /L

4.S.Iron content < 50 μg /L

5.MCHC < 34 g/dl

6.MCV <80 fl

7.Peripheral smear picture suggestive of Microcytic Hypochromic Anaemia

8.Willing and able to participate for 84 days

Exclusion Criteria

1.Stool examination found with positive ova/cyst/parasite of

worm infestation

2.Any continuing blood loss due to haematemesis, melena and

bleeding piles etc

3.Dimorphic anaemia

4.Patients who cannot report in person every 2 weeks in the OPD

5.Patients with poorly controlled Hypertension ( >160/100 mmHg)

6.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 7.5%

7.Patients with evidence of malignancy

8.History of chronic infections.

9.Patients on medication with any other drugs that may have an influence on the outcome of the study.

10.Known case of cardiovascular diseases

11.Known HIV positive cases

12.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]),

13.Alcoholics and/or drug abusers

14.H/o hypersensitivity to any of the trial drugs or their ingredients

15.Pregnant/lactating woman.

16.Patients who have completed participation in any other clinical trial during the past six months.

17.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change (increase) in Hb%Timepoint: Change (increase) in Hb%

Secondary Outcome Measures

Name	Time	Method
Symptomatic relief,Change (increase) in Serrum Ferritin level and normacy of Peripheral Blood Smear picture <br/ ><br>Timepoint: 28th, 56th, and 84th day