Clinical research study of vallarai nei (Internal medicine) in the treatment of Pithapandu(Iron deficiency Anaemia)

Phase 2

Recruiting

• Conditions: PITHA PANDU(IRON DEFICIENCY ANAEMIA)

• Registration Number: CTRI/2016/01/006557
• Lead Sponsor: AYOTHIDOSS PANDITHAR HOSPITAL

Brief Summary

It is a single, non -randomized,open -label trial to determine the efficacy and safety of VALLARAI NEI(Prepared from 20 herbal constituents and cow ghee and rock sugar) in patients with Pitha pandu (IRON DEFICIENCY ANAEMIA).In this trial 40 patients will be recruited and before starting the treatment ,purgation will be given with OP medicine Meganatha kuligai 2 pills with ginger juice at early morning at empty stomach for one day.Then the trial drug VALLARAI NEI will be administrated 4ml twice a day after food for a period of 48 days.During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients. During  the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in OPD /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

• Study Start: 2015-07-30
• Last Update Posted: 2016-01-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)Hemoglobin level less than normal range For male 7 to 12gms/dl For female 7 to 11gms/dl 2)Patient blood smear shows Microcytic Hypochromic RBC 3)Patient willing to undergo blood investigation 4)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

1)Parasitic infection 2)Pregnancy and lactation 3)History of bronchial asthma 4)History of sinusitis 5)Presence of any severe illness(CA,RA) 6)Endocrine disorder( thyroid abnormality diabetes mellitus) 7)History of cardiac disease 8)History of renal disease 9)Inherited defects like sickle cell anemia thalassemia aplastic anemia 10)Patient not willing to give blood sample 11)Epilepsy.

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 Haemoglobin level of the trial patient	Prestudy screening and after treatment

Secondary Outcome Measures

Name	Time	Method
It is assessed by comparing following parameters before and after treatment	1)Reduction of clinical symptoms

Trial Locations

Locations (1)

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

Ayothidoss pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

DR K RAJALAKSHMI

Principal investigator

9003010579

drkrajalaxmibsms@gmail.com