Clinical study of siddha medicine "Chitramutti Nei" in the treatment of Azhal Pandu(Iron deficiency anemia)

Phase 2

Not yet recruiting

• Conditions: Azhal Pandu (Iron deficiency anemia)

• Registration Number: CTRI/2018/01/011179
• Lead Sponsor: Ayothidoss Pandithar Hospital

Brief Summary

It is a single non randomized open - label trial to determine the efficacy and safety of Chitramutti nei in patients with Azhal Pandu (Iron deficiency Anemia). In this trial 40 Iron deficiency Anemia patients will be recruited and the trial drug will be administered 4 ml twice a day along with hot water for a period 45 days. During the study period all the study related data will be recorded and documented in a separate trail master file for each patients. During the trial period if any adverse effect will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD and IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-07-01
• Study Start: 2018-12-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Hb level less than normal range, For male : 7-12gms/d1{13-18gms/d1}.
• For female :7-11gms /d1{11.5-16.5gms/d1}.
• Patient willing to undergo blood investigation.
• Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48days but can opt out of the trial of his/her own conscious discretion.

Exclusion Criteria

• Hypertension.pregnancy and lactation.
• presence of any associated severe systemic illness.(e.g. CA,RA) Endocrine disorder(Thyroid abnormality,Diabetes mellitus) Cardiac disease.Renal disease.Inherited defects (sickle cell anemia, Thalassemia,Aplastic anemia) Patient not willing to give blood sample.
• Epilepsy.Worm infestation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is mainly assessed by comparing the pre and post treatment Hemoglobin level, of the trial patient.	45 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is assessed by comparing the following parameters,before and after the treatment.reduction of clinical symptoms.changes in complete blood count.changes in serum ferritin level	45 days

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

DrMSShakila

Principal investigator

8681918617

shakilav2010@gmail.com