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

Phase 4

Not yet recruiting

• Conditions: Other iron deficiency anemias,

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

Brief Summary

An open label, Interventional and Prospective study is proposed for the duration of two years for the

clinical assessment of Drakshavaleha in the management of Pandu (Iron Deficiency Anaemia).

Sample size of 60 will be randomly drawn from the OPD of RARIND jaral pandoh, Himachal Pradesh.

Sample will be assessed by the inclusion criteria and will be treated with 10 gm of Drakshavaleha

twice a day before meals with Luke warm water. Patients will be followed on predefined days of the

84 days trial period and will be evaluated for various subjective and objective parameters. Data will

be gathered, generated and analysed according to appropriate statistical method.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-09
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients of either sex aged between18 to 50 years.
• IDA documented by hematologic indices.
• Hb 8gm-10gm.
• 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.

Exclusion Criteria

• Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
• 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.
• 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.
• 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]).
• 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.	Time Frame: Every 4 weeks (on day 0, 28th,56th,84th and 112th)

Secondary Outcome Measures

Name	Time	Method
Serum Ferritin level,	Serum Iron level,

Trial Locations

Locations (1)

Regional Ayurveda Research Institute For Nutritional Disorders; 🇮🇳 Mandi, HIMACHAL PRADESH, India

Regional Ayurveda Research Institute For Nutritional Disorders

🇮🇳Mandi, HIMACHAL PRADESH, India

Dr SK Sharma

Principal investigator

9418062731

dr.sk.sharma.ad@gmail.com