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CTRI Number  CTRI/2025/01/079021 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Exploring The Impact Of Homoeopathic Medicines On Iron Deficiency Anaemia In Adolescent Girls Aged 10-18 Years 
Scientific Title of Study   Exploring The Impact Of Homoeopathic Medicines On Iron Deficiency Anaemia In Adolescent Girls Aged 10-18 Years 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janvi Vipulbhai Trivedi 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Pediatrics Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  7228008058  
Fax    
Email  janvi3796@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prachi Shah 
Designation  Assistant Professor (Department of Paediatrics) 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Pediatrics Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9429510435  
Fax    
Email  p.r.parikh11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prachi Shah 
Designation  Assistant Professor (Department of Paediatrics) 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital 
Address  Department Of Pediatrics Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9429510435  
Fax    
Email  p.r.parikh11@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine and Hospital 
Address  C D Pachchigar College Of Homoeopathic Medicine And Hospital, Near Anand Mangal Society, Udhana Magdalla Road, Bhatar, Surat 395001 Gujarat India 
Type of Sponsor  Private medical college 
 
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 Janvi Vipulbhai Trivedi  C D Pachchigar College Of Homoeopathic Medicine And Hospital  Department Of Pediatrics Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat
Surat
GUJARAT 
7228008058

janvi3796@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C D Pachchigar College Of Homoeopathic Medicine And Hospital  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 
Intervention  Homoeopathic Medicine  Homoeopathic Medicine Dose As Per Requirement Of Case Through Sublingual Mode Of Administration Within Time Duration Of 9 Months 
Comparator Agent  Not applicable  Not Applicable 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  Cases which are diagnosed iron deficiency clinically according to medical history and signs and symptoms.
Previously diagnosed cases of iron deficiency anaemia.

 
 
ExclusionCriteria 
Details  Cases with complications or associated with advanced pathological conditions, birth defects, poisoning and other types of anaemia.
Critical emergency cases  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study how homoeopathy helps to mitigate the causes of iron
deficiency anaemia and improves functioning of patient. 
9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement in clinical picture of person as whole with iron
deficiency anemia with homoeopathic similimum.  
To improve the physical generals of patients on regular treatment within 2 months & after that will assess improvement in laboratory reports within 4 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/01/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

6

BRIEF  RESUME  OF  INTENDED  WORK:

6.1

NEED  FOR  STUDY:

 Globally, anaemia is one of the biggest public health challenges having major health, economic, and social consequences.

 

 As per the latest report of the National Family Health Survey 5, the prevalence of anaemia has worsened in most of the states and union territories across India in the past half a decade. (1)

 

 The prevalence among the adolescents is reported to be high, with close to 50% of the surveyed population being anaemic. It commensurate with the findings of National Family Health Survey 5, where the prevalence among six groups is: 25.0% in men (15-49 years) and 57.0% in women (15-49 years), 31.1% in adolescent boys (15-19 years), 59.1%in adolescent girls (15-19 years), 52.2% in pregnant women (15-49 years), and 67.1% in children (6-59 months). (1)

 

 Highest prevalence of anaemia is seen among adolescents, as the nutritional requirements are the maximum during this time. Adequate nutrition is important as it is the period of rapid growth and poor nutrition can lead to impaired physical and mental ability with lifelong consequences.  

 

 Iron deficiency is by far the most common cause of anaemia worldwide and a multifaceted nutritional public health matter with far reaching consequences.

 

 The risk factors of iron deficiency anaemia among adolescents are conglomerate. (6) Adolescent girls are considered particularly at high risk due to their unique physical and physiological changes that occur during this stage of life. Iron loss during menstruation and inadequate iron intake can easily put them in state of developing iron deficiency anemia. Factors such as limited decision-making power – low educational status, financial autonomy, and restricted healthcare access may exacerbate these risks.

(3)  

 

 Thus the challenge of rapid growth and development during the period coupled with menstrual blood loss among females and diets with poor bioavailability of iron especially in the low- and middle- income countries has categorized adolescent girls as vulnerable group. (2)

 

 Addressing anaemia among adolescent girls is a key step to ensure that they have adequate opportunities to reach their full potential.

 

 

 

 The major problem of this disease is that it has very gradual onset without any apparent signs and symptoms remaining silent for long time still producing exhaustion of the human economy. 

 

 In this regard homoeopathy has better scope because according to Hahnemannian classification, anaemia is chronic disease which can be treated by homoeopathic similimum. By curing anaemia one can prevent many illnesses. Understanding individualized homoeopathic similimum and its effectiveness in providing gentle and safe cure with highest satisfaction of patient after treatment is a worthwhile study.

 

 If the dosages are taken regularly, iron deficiency anaemia can be treated without having to bear any intolerance or adverse effects due to standardly prescribed oral or parental preparations. 

6.2

REVIEW  OF  LITERATURE:

 

INTRODUCTION: 

 

 Anaemia is a pathophysiological condition in which the reduction of packed cell volumes, (measured by haematocrit), erythrocyte or haemoglobin concentration, or both in circulating blood is below the normal range. The World Health Organization (WHO) defines anaemia as a haemoglobin level <13g/dl in men and <12g/dl in women. (3)

 

 The most common cause of anaemia worldwide is iron deficiency. Several causes of iron deficiency vary based on age, gender, and socioeconomic status. (4)

 

ETIOLOGY:  (5)

  

 Iron deficiency may result from:

 

           Physiological causes involving post-natal growth spurt, adolescent growth spurt, menstruation and pregnancy. 

 

           Iron loss due to hook worm infestation, schistosomiasis, menorrhagia, post-partum haemorrhage, peptic ulcer, piles, neoplastic diseases, gastric erosions from anti-inflammatory drugs, malaria (intravascular haemolysis with subsequent loss of haemoglobin iron in urine; also suppresses erythropoiesis) 

 

           Inadequate diet: excessive consumption of cow milk in children, food fads

 

           Malabsorption (reduced iron absorption) in inflammatory bowel disease, post-gastrectomy, coeliac disease, autoimmune gastric atrophy,

Helicobacter pylori gastritis.

 

 

 

IRON:

 

 Iron is necessary for many functions in the body including formation of haemoglobin, brain development and function, regulation of body temperature, muscle activity, and catecholamine metabolism. Lack of iron directly affects the immune system; it diminishes the number of T-cells and the production of antibodies. Besides haemoglobin, iron is a component of myoglobin, the cytochromes, catalase and certain enzyme systems. Iron is essential for binding oxygen to the blood cells. The central function of iron is "oxygen transport", and cell respiration.

 

 

SOURCES OF IRON: (7)

 

 There are two forms of iron, haem-iron and non-haem iron. Haem-iron is better absorbed than non-haem iron. 

 

 Foods rich in haem-iron are liver, meat, poultry and fish.

 

 The iron content of milk is low in all mammalian species.

 

 Foods containing non-haem iron are those of vegetable origin, e.g., cereals, green leafy vegetables, legumes, nuts, oilseeds, jaggery and dried fruits. They are important sources of iron in the diets of a large majority of Indian people. The bioavailability of non-haem iron is poor owing to the presence of phytates, oxalates, carbonates, phosphates and dietary fibre which interfere with iron absorption. 

 

 Other foods which inhibit iron absorption are milk, eggs and tea. The Indian diet which is predominantly vegetarian contains large amounts of these inhibitors, e.g., phytates in bran, phosphates in egg yolk, tannin in tea and oxalates in vegetables. In some areas, significant amounts of iron may be derived from cooking in iron vessels.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IRON CYCLE IN HUMANS:

 

 

 (8)

 

 

 

 

 

 

STAGES OF IRON DEFICIENCY: (9)

 

 The progression to iron deficiency can be divided into three stages: 

           Negative iron balance

           Iron deficient erythropoiesis

           Iron deficiency anaemia

 

 (10)

 

 

CLINICAL PRESENTATION OF IRON DEFICIENCY: (5)

 

 Signs related to iron deficiency depend on the severity and chronicity of the anaemia in addition to the usual signs of anaemia—fatigue, pallor, and reduced exercise capacity. 

 

 Pallor is the most recognized clinical sign of iron-deficiency anaemia but is not usually visible until the haemoglobin falls to 7-8 g/dL. It is most readily noted as pallor of the palms, palmar creases, nail beds, or conjunctivae.

 

 Most children with iron-deficiency anaemia are asymptomatic and are identified by routine laboratory screening.

 

 

 

 

Characteristic features of iron deficiency include the following: 

           Angular stomatitis, cheilosis

           Glossitis 

           Brittle fingernails, platonychia, koilonychia 

           Pica indicates a craving for non-nutritive and substances like coal, earth (geophagia), tomatoes, greens, starch and ice (pagophagia). 

           Restless leg syndrome (compulsion to move limbs while at rest) may occur due to reduced brain iron levels

 

 Plummer-Vinson syndrome (sideropenic dysphagia; Patterson-Kelly syndrome) occurs in long-standing iron deficiency. 

 

 Older individuals may report cold intolerance, fatigue, exercise-induced dyspnoea, or decreased mental acuity.

 

 In mild to moderate iron-deficiency anaemia (i.e., haemoglobin levels of 6-10 g/dL), compensatory mechanisms, including increased levels of 2,3diphosphoglycerate and a shift of the oxygen dissociation curve, may be so effective that few symptoms of anaemia aside from mild irritability are noted.

 

 When the haemoglobin level falls to <5g/dl, irritability, anorexia, and lethargy develop, and systolic flow murmurs are often heard. If the haemoglobin continues to fall, tachycardia and high output cardiac failure can occur.

 

 

DIAGNOSIS:  

 

 A presumptive diagnosis of iron-deficiency anaemia is most often made by a complete blood count (CBC) demonstrating a microcytic hypochromic

anaemia. (11) (12)

 

 Laboratory investigations show:

           Low hemoglobin (Hg) and hematocrit (Hct)

           High RDW

           Reduced RBC count, normal WBC count and normal or elevated platelet count

           Reduced serum ferritin and serum iron

           Increased total iron-binding capacity 

           Reduced plasma transferrin saturation

           Elevated red cell protoporphyrin (normal <30ug/dl). 

           Serum soluble transferrin receptor is increased 

           Elliptical cells and poikilocytes are seen in severe case. 

 

 

 

 

    

DIFFERENTIAL DIAGNOSIS: (5) (11)

 

 The most common alternative causes of microcytic anaemia are α- or βthalassemia and other hemoglobinopathies like sideroblastic anaemia. The anaemia of inflammation is usually normocytic but can be microcytic in a minority of cases. Lead poisoning can cause microcytic anaemia, but more often the microcytic anaemia is caused by iron deficiency resulting in pica and secondary lead intoxication.

 

 

(9)

 

PREVENTION AND CONTROL OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS

 

 Primary prevention of anaemia is achieved through well- balanced diet rich in iron and other vitamins and minerals involved in iron absorption or in the production of RBCs/Haemoglobin.

 

CONVENTIONAL TREATMENT  (5)

 

 The severity and cause of iron-deficiency anemia will determine the appropriate approach to treatment. For the majority of cases of iron deficiency oral iron therapy will suffice. For patients with unusual blood loss or malabsorption, specific diagnostic tests and appropriate therapy take priority. Once the diagnosis of iron-deficiency anemia and its cause is made, there are three major therapeutic approaches: 1. Oral iron therapy, 2. Parenteral iron therapy, 3. Red cell transfusion 

 Iron supplementation is taken without food to increase absorption. Low gastric pH facilitates iron absorption. Rapid response to treatment is often seen in 14 days. It is manifested by the rise in haemoglobin levels. Iron supplementation is needed for at least three months to replenish tissue iron stores and should proceed for atleast a month even after haemoglobin has returned to normal levels. Multiple preparations are available, ranging from simple iron salts to complex iron compounds

 

 

designed for sustained release throughout the small intestine. Ferrous sulfate is an inexpensive and effective therapy, usually given in two to three divided doses daily. The adverse effects of oral iron include constipation, nausea, decreased appetite, and diarrhoea. 

 Multiple preparations are available, ranging from simple iron salts to complex iron compounds designed for sustained release throughout the small intestine. 

 (9)

 Intravenous iron can be given to patients who are unable to tolerate oral iron; whose needs are relatively acute; or who need iron on an ongoing basis, usually due to persistent gastrointestinal or menstrual blood loss. Although intravenous iron is more reliably and quickly distributed to the reticuloendothelial system than oral iron, it does not provide for a more rapid increase in haemoglobin levels.

 Parenteral iron is used in two ways: one is to administer the total dose of iron required to correct the haemoglobin deficit and provide the patient with at least 500 mg of iron stores; the second is to give repeated small doses of parenteral iron over a protracted period

 The newer iron complexes that are available, such as ferumoxytol (Feraheme), sodium ferric gluconate (Ferrlecit), iron sucrose (Venofer), low-molecular-weight (LMW) iron dextran (InFed), and ferric carboxymaltose (Injectafer), have much lower rates of adverse effects.

 The most common adverse effect of intravenous iron is nausea. While rare, anaphylaxis may occur with intravenous iron infusions. Extravasation of iron solutions into the subcutaneous tissue causes brownish stains that can be permanent and aesthetically unpleasant for the patient. 

 Dietary counselling is also usually necessary for management.

 

 

 

 

 

 

HOMOEOPATHIC CONCEPT: 

 

 Homoeopathic management focuses on treating the whole person rather than disease alone. 

 

 The concept of individualization lies at the core emphasizing the uniqueness of each person’s response to illness. Homeopathy goes beyond simply diagnosing diseases based on common symptoms; it delves deeper into understanding the individual’s constitution, including physical, intellectual, and emotional attributes. (13)

 

 Each person’s constitution reflects a combination of genetic predispositions and environmental influences, shaping their response to illness. This individualized response manifests through a diverse array of signs and symptoms, which vary even when exposed to identical diseaseproducing factors. These differences enable homeopathic physicians to differentiate between cases and select the most suitable remedy. (14)

 

 In homeopathy, the goal is to identify the Similimum, or the remedy that closely matches the totality of symptoms expressed by the individual. This requires a meticulous analysis of both common diagnostic features and unique characteristics exhibited by the patient. Along with indicated remedy or similimum, the diet and regimen play a pivotal role in treating diseases. Homeopathic management aims not only to treat iron deficiency anemia but also to address its underlying cause and individual susceptibility, providing a cure with no recurrence.

 

 Some commonly used homeopathic medications for iron deficiency anemia include Ferrum Met, Ferrum Phos, Calc carb, Cinchona officinalis,

Nat Mur, Pulsatilla, Phosphorus, Zincum, Sepia, and Nit acid. (15) (16) (17)

 

6.3

 

 

 

OBJECTIVE OF THE STUDY:

           Review the presentation of a patient with iron deficiency, most commonly due to inadequate diet and iron loss during menstruation.

           To study how homoeopathy helps to mitigate the causes of iron deficiency anaemia and improves functioning of patient.

           To assess improvement in clinical picture of person as whole with iron deficiency anemia with homoeopathic similimum.

 

 

 

7

MATERIAL AND METHODS:

7.1

SOURCES OF DATA:

 PROJECT SITE:

           OPDs & IPDs of institute.

           Peripheral OPDs run by institute.

           Camps arranged by the institute.

 

7.2

MATERIALS:

 Case records from institute.

7.3

METHOD OF COLLECTION OF DATA:

1.     Study design: Experimental study 

 

2.     Study type: Prospective Study

 

3.     Study Population: Adolescent girls having iron deficiency anaemia (Age: 10-18-years old) attending institute. 

 

4.     Sample Size: 30 Cases

 

5.     Sample Techniques: Simple Random Sampling

 

6.     Selection criteria:

 

 Inclusion criteria:

1.     Age group of 10-18 years girls

2.     Cases which are diagnosed iron deficiency clinically according to medical history and signs and symptoms

3.     Previously diagnosed cases of iron deficiency anaemia

 

 Exclusion criteria:

1. Cases with complications or associated with advanced pathological conditions, birth defects, poisoning and other types of anaemia. 2. Critical emergency cases 

 

 

 

 

 Case taking will be done according to guidelines mentioned by Dr. Hahnemann in Aphorisms 83-104. 

 

 After proper analysis and evaluation of symptoms, totality of symptoms will be formed.

 

 Totality formation will be done as per the instructions given by Dr. Hahnemann in organon of medicine.

 

 Investigations for diagnosis of the disease will be done as per the requirement of the case. 

 

 The remedy will be selected on the basis of totality of symptoms and/ either from reportorial or non-reportorial approach.

 

 The remedies will be used in various potency as per the requirement of the case.

 

 Remedies will be administered as per guidelines given by Dr. Hahnemann.

 

 The remedies will be repeated as per the requirement of the case, on the basis of teachings of Dr. Hahnemann in Organon of medicine

 

 

7.4

DOES THE STUDY

REQUIRING ANY

INVESTIGATION TO  BE

CONDUCTED  ON  PATIENTS  OR OTHER  HUMANS  OR  ANIMALS?

 

 

 

Laboratory investigations will be done as and when required on respective individuals.

7.5

 

HAS ETHICAL

CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE?

 

Yes

 

8.

 

 

 

 

 

 

 

BIBLIOGRAPHY

 

1.      Welfare MoHaF. [Online].; 4 february 2022 [cited 2023. Available from: https://pib.gov.in/PressReleasePage.aspx?PRID=1795421.

2.      Jyotiranjan Sahoo SMSGSKPSMDPaV. Prevalence and Risk Factors of

Iron Deficiency Anemia among the Tribal Residential Adolescent School Students of Odisha: A Cross-Sectional Study. Indian Journal Of Community Medicine. 2023 July-August.

3.      Aditya Singh MC. National Library of Medicine. [Online].; 2023 Sep [cited 2023. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10482272/.

4.      Warner MJ, Kamran. MT. National Library of Medicine. [Online].; August 2023 [cited 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK448065/.

5.      K George Mathew PA. Medicine Prep Manual For Undergraduates. 5th ed.: Elsevier.

6.      Michael Akenteng Wiafe JADC. A Review of the Risk Factors for Iron Deficiency Anaemia among Adolescents in Developing Countries. Hindawi; Anemia. 2023 January.

7.      Park K. Parks textbook of Preventive and Social Medicine. 25th ed.: Banarsidas Bhanot; 2019.

8.      Researchgate. [Online]. Available from: https://www.researchgate.net/figure/Distribution-of-iron-inadults_fig1_277759837.

9.      Jameson FKHLL. Harrision’s Principles of Internal Medicine. 20th ed. Jameson FKHLL, editor.: Mc Graw Hill Education; 2018.

10.  Coad &Kevin Pedley J. Iron deficiency and iron deficiency anemia in women. Scandinavian Journal of Clinical and Laboratory Investigation. 2014 August.

11.  Kliegman SGBSTW. NELSON TEXTBOOK OF PEDIATRICS. 21st ed.:

Elsevier; 2020.

12.  Penman RSH. Davidson’s Principles and Practice of Medicine. 24th ed.

Penman RSH, editor.: Elsevier.

 

 

13.  Dhawale DML. Principles and Practice of Homoeopathy: B Jain Publishers; 2014.

14.  B. K. Sarkar RED. Hahnemann’s Organon Of Medicine. 20162017th ed.: Birla Publications Pvt. Ltd..

15.  Dewey WA. Practical Homeopathic Therapeutics. Arranged and compiled ed. Philadelphia: Boericke and Tafel; 1901.

16.  Farrington EA. A Clinical Materia Medica. 4th ed. Philadelphia; 1908.

17.  S. Lilienthal M. Homeopathic Therapeutics. 2nd ed.: Boericke and Tafel; 1879.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 
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