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CTRI Number  CTRI/2017/12/010959 [Registered on: 22/12/2017] Trial Registered Retrospectively
Last Modified On: 13/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Himferra Capsules for Anemia 
Scientific Title of Study   A Clinical Comparative study to evaluate the safety and efficacy of Himfera capsules in the Management of Iron Deficiency Anaemia 
Trial Acronym  HC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr R Mohandhas 
Designation  Principal Investigator 
Affiliation  Ramya Hospital 
Address  Department of Medicine Ramya Hospital Parakkai road Velladichivilai Edalakudy Nagercoil

Chennai
TAMIL NADU
629052
India 
Phone    
Fax    
Email  dr.palani@himalayawellness.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr R Mohandhas 
Designation   
Affiliation  Ramya Hospital 
Address  Department of Medicine Ramya Hospital Parakkai road Velladichivilai Edalakudy Nagercoil

Chennai
TAMIL NADU
629052
India 
Phone    
Fax    
Email  dr.palani@himalayawellness.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr R Mohandhas 
Designation   
Affiliation  Ramya Hospital 
Address  Department of Medicine Ramya Hospital Parakkai road Velladichivilai Edalakudy Nagercoil

Chennai
TAMIL NADU
629052
India 
Phone    
Fax    
Email  dr.palani@himalayawellness.com  
 
Source of Monetary or Material Support  
The Himalaya Drug Company Makali Bangalore - 562162 
 
Primary Sponsor  
Name  The Himalaya Drug Company 
Address  The Himalaya Drug Company Makali  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Farida Khanum  Healing Earth Multi-Specialty Ayurveda Hospital  Healing Earth Multi-Specialty Ayurveda Hospital, #149, H.S.R. Ring Road, H.S.R. Layout, 5th Sector, Bangalore-560034.
Bangalore
KARNATAKA 		 9886329022

drfaridakhanum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECNP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  individuals with Iron Deficiency Anaemia (IDA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fefol Capsule   Composition: Fefol Capsule is composed of the following active ingredients (salts) Folic acid (vitamin B9) (0.5 mg) Ferrous sulphate (150 mg) Please note that this medicine may be available in various strengths for each active ingredient listed above. Clinical Pharmacology: Fefol Capsule is indicated for the treatment of anaemic due to folic acid deficiency, poor diet, poor absorption of food, increased requirement of folate in the body during pregnancy, folate deficiency, anaemic and other conditions. Fefol belongs to a group of medicines known as haematinics, which improve the blood’s ability to carry oxygen. They do this by increasing the amount of haemoglobin, the iron-containing respiratory pigment, which is carried in the red blood cells. Fefol is used to prevent iron and folic acid deficiency during pregnancy, after the first thirteen weeks. Pregnancy and Breast-feeding Do not use this medicine during the first thirteen weeks of pregnancy. Your doctor will decide if you need to take this medicine during the remaining period of pregnancy. Storage Conditions: Keep out of the reach and sight of children. Do not store above 25° C. Keep the capsules in the carton in order to protect from light. Do not use after the expiry date on the pack. Treatment Fefol Capsule is used in the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms like Anaemic due to folic acid deficiency, Poor diet, Poor absorption of food, Increased requirement of folate in the body during pregnancy, Folate deficiency, Anaemic and During pregnancy. Mechanism of Action and Pharmacology Fefol Capsule improves the patients condition by performing the following functions: Producing and maturing the red blood cells. Producing blood cells and platelets in the body.  
Intervention  Himfera Capsules  Each Himfera capsule contains: Pdrs. Shuddha Kasisa (Ferrous sulphate) 150 mg Exts. Shunti (Zingiber officinale) 17 mg Amalaki (Emblica officinalis) 38 mg Punarnava (Boerhaavia diffusa) 45 mg  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects of both sexes in the age group of 18-70 years with Hemoglobin <11gm/dL.
Subjects who have clinical symptoms such as pale skin colour, extreme fatigue, irritability, weakness, brittle nails, palpitation, headache, loss of appetite.
Subjective improvement in quality of life in subjects with Iron deficiency anaemic.
Subjects willing to give written informed consent.
Subjects who have not participated in similar kind of study in last 3 months.
 
 
ExclusionCriteria 
Details  Subjects with hemoglobin concentration < 6 gm/dl, patients of thalassaemia, sickle cell anemia, aplastic anemia, haemolytic anemia, lead poisoning, sideroblastic anaemia, malignancies, congenital.
Blood hemoglobin level < 5 gm/dl during the course of any treatment, any other acute illness, severe untoward effect.
Absence of iron binding protein, hereditory spherocytosis and any association of severe complication.
Pregnant & lactating women.
Not willing to sign informed consent form.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Change in anaemia-related blood parameter levels
An improvement in biochemical parameters viz. serum iron hemoglobin levels and erythrocyte counts.
Improvement in symptoms such as skin pallor, tiredness and lack of energy, headache, weakness, low performance, appetite, breathlessness and feeling of wellbeing.
Subjective improvement in quality of life in subjects with Iron deficiency anaemic.
 		 Patients will be followed up and the results were assessed from baseline on visit days:
Visit 0- Baseline
Visit 1 - At the end of Month 1
Visit 2- At the end of Month 2 (End of the study)
 
 
Secondary Outcome  
Outcome  TimePoints 
Compliance of the subject to the drug treatment and the adverse effects will be noted.  Patients will be followed up and the results were assessed from baseline on visit days:
Visit 0- Baseline
Visit 1 - At the end of Month 1
Visit 2- At the end of Month 2 (End of the study)
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/10/2017 
Date of Study Completion (India) 29/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This will be a comparative clinical study consisting of 40 subjects who fulfil the subject selection. According to the study, all the subjects will be advised to take 1 Himfera capsules or standard iron supplement which will be coded during the study as Himfera A or B twice daily for a period of 2 months.

 
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