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CTRI Number  CTRI/2024/10/074733 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of the Homoeoapthic medicine Venadium metallicum in Anaemia of Women 
Scientific Title of Study   A Clinical study on the Effectiveness of Homoeopathic medicine Vanadium metallicum 6CH in the treatment of Iron deficiency anemia in Reproductive age group women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandhini R 
Designation  PG SCHOLAR 
Affiliation  Vinayaka missions Homoeopathic Medical college and hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47,Sankari Main Road,Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  8610747174  
Fax    
Email  rpnandhini5799@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. H. Venkatesan 
Designation  Professor and Head 
Affiliation  Vinayaka missions Homoeopathic Medical college and hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47,Sankari Main Road,Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nandhini R 
Designation  PG SCHOLAR 
Affiliation  Vinayaka missions Homoeopathic Medical college and hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47,Sankari Main Road,Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  8610747174  
Fax    
Email  rpnandhini5799@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47,SANKARI MAIN ROAD,SEERAGAPADI PO,SALEM,TAMILNADU - 636308  
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  NH 47,SANKARI MAIN ROAD,SEERAGAPADI PO,SALEM,TAMILNADU-636308 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nandhini R  Vinayaka Missions Homoeopathic Medical College and Hospital  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47,Sankari Main Road,Seeragapadi PO
Salem
TAMIL NADU 
8610747174

rpnandhini5799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinayaka Missions Kirubanandha Variyar Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50||Iron deficiency anemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Venadium metallicum 6CH  4 medicated pills(30 size) per oral route daily two doses for 120 days 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Iron Deficiency Anaemia Patients with Hb % between 8 to 11 gms/dL 
 
ExclusionCriteria 
Details  1. Severe Anaemia Patients with Hb % Less than 7 gms/dL
2. Females with Menorrhagia
3. Pregnancy and lactation
4. Recent Blood donors with in 4 Months after Donation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Increase in Blood Hb Concentration
2. Increse in Serum Ferritin Levels 
4 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Haemogram - MCV and MCHC improvement  4 Months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Iron deficiency anemia arises when the balance of iron intake, iron stores, and the body's loss of
iron are insufficient to fully support production of erythrocytes. Iron deficiency anemia rarely
causes death, but the impact on human health is significant.
In the developed world, this disease is easily identified and treated, but frequently overlooked
by physicians. In contrast, it is a health problem that affects major portions of the population in
underdeveloped countries.
Overall, the prevention and successful treatment for iron deficiency anemia remains woefully
insufficient worldwide, especially among underprivileged women and children[1].Iron
deficiency can result in fatigue, poor concentration (brain fog), alopecia, ridged/brittle nails,
aching and restless legs, reduced exercise tolerance, anxiety, low mood/depression and poor
work performance. Cognitive decline has also been reported in elderly individuals. In severe
cases, pica – a craving and purposive consumption for non-food items such as ice (pagophagia)
and starch (amylophagia) may develop, especially in women whose serum ferritin
< 10 µg.l-1.[2]
Homoeopathic medicines are quite effective in management of iron deficiency anemia and the
remedies includes Ferrum phosphoricum, Arsenicum album, Apis mellifica,cinchona
officinalis, Vanadium, Gelsemium etc., Vanadium metallicum helps in the improvement of
appetite and body, strength, it has positive effects on nutritional anaemia it acts as an oxygen
carrier and catalyzer, it's increasing haemoglobin levels.[3]
Hence this study is to evaluate the effectiveness of homoeopathy medicine Vanadium
metallicum 6CH in treatment of iron deficiency anemia by increasing hemoglobin
concentration, mean corpuscular hemoglobin and serrum ferritin.

DRUG DESCRIPTION
Vanadium metallicum belongs to metal group with a atomic weight of 5.1
it is derived from vanadis a goddess of scandenvian mythology.it is obtained from the iron
ores of Sweden,it is analogous to chromium. [17]
Absorption and Distribution of Vanadium
A significant amount of vanadium absorption occurs in the upper gastrointestinal tract.
Most ingested vanadium probably is transformed to VO2+ in the stomach and passes into the
duodenum in this form
In serum, absorbed vanadium is transported mainly bound to transferrin [22]
Its action is that of an oxygen carrier and catalyzer, increases the amount
of hemoglobin .also increases and stimulates the phagocytes [18] .
Anemia, Emaciation. A remedy for degenerative conditions of liver
and arteries. acts as a tonic for digestivc functions.,
Addison’s disease, Atheroma fatty degeneration, innutrition [19]
In general, the toxicity of vanadium compounds is low.
Pentavalent compounds are the most toxic and the toxicity of vanadium compounds
usually increases as the valence increases. Most of the toxic effects of vanadium compounds
result from local irritation of the eyes and upper respiratory tract rather
than systemic toxicity [20] .
Experiments on animals ; the general action on animal system when injected into the veins
or alimentary canal ,is paralysis of motion ,convulsion ,local or general ,rapidly
supervening drowsiness or indifference to external circumstances congestion of
alimentary canal. Drowsiness and feebleness of pulse, [21]
 
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