Determining the efficacy of Homoeopathic Similimum as an adjuvant therapy in modulating different blood parameters (cbc, sr. Iron, sr. Ferritin, sr. Transferrin, tibc) in iron deficiency anaemia of mild to moderate grades in adolescent girls - a randomized placebo - controlled clinical trial.

Anaemia is a condition in which the number of red blood cells or the hemoglobin concentration within them is lower than normal. Hemoglobin is needed to carry oxygen and if you have too few or abnormal red blood cells, or not enough hemoglobin, there will be a decreased capacity of the blood to carry oxygen to the body’s tissues. This results in symptoms such as fatigue, weakness, dizziness and shortness of breath, among others. The optimal hemoglobin concentration needed to meet physiologic needs varies by age, sex, elevation of residence, smoking habits and pregnancy status. The most common causes of anaemia include nutritional deficiencies, particularly iron deficiency, though deficiencies in folate, vitamins B12 and A are also important causes; hemoglobinopathies; and infectious diseases, such as malaria, tuberculosis, HIV and parasitic infections.

According to the National Family Health Survey (NFHS-4, 2015–16 & NFHS-5, 2019–20) in India, the prevalence of anaemia has been increased 6.2% in 2019-20 from 2015 to 16. The changes result shows that few districts have in improvising stage of women health but, the majority of the state districts of Maharashtra highlighting a serious health picture. Out of 36 districts, 16 districts have a higher prevalence of more than 55% of anaemia in Maharashtra.

The most common causes of anaemia include nutritional deficiencies, particularly iron deficiency, though deficiencies in folate, vitamins B12 and A are also important causes; hemoglobinopathies; and infectious diseases, such as malaria, tuberculosis, HIV and parasitic infections.

study design - A Randomized Placebo-Controlled Clinical Trial. ï‚· Group 1- Similimum with Iron supplements ï‚· Group 2- Placebo with Iron supplements

study type : Experimental

study setting  : Cases from all OPD’s and IPD’s of hospital, peripheral and private clinics and other Homoeopathic centers and medical camps. i) STUDY POPULATION Adolescent girls of age group 10 to 19 years suffering from mild to moderate grades of iron deficiency anaemia with altered blood parameters (CBC, SR. IRON, SR. FERRITIN, SR. TRANSFERRIN, TIBC) of various socieo-economic statuses.

inclusion criteria: 1. Adolescent girls between 10 to 19 years. 2. Suffering from mild to moderate grades of iron deficiency anaemia 3. Iron deficiency anemia with altered blood parameters (CBC, SR. IRON, SR. FERRITIN, SR. TRANSFERRIN, TIBC)

exclusion criteria: 1.Pregnant adolescent girls. 2. Suffering from known chronic systemic illness, other types of iron deficiency anaemia. E.g. Thalassemia, Sickle Cell Anemia, Hemochromatosis.

subject withdrawl criteria : 1. If a Patient is landed in life threatening condition. 2. If Patient start immunosuppressive therapy. 3. Patient is not maintaining proper follow up and any Obstacle in recovery which appear after commencement of study during process of treatment. 4. Patient is not taking medicine as instructed.

sampling technique - simple random sampling

data collection method:  1. Screening of subjects 2. Written Informed Consent will be taken. 3. The detailed Homeopathic case taking will be carried out. 4. Investigation – CBC, SR. FERRITIN, SR. IRON, SR. TRANSFERRIN, TIBC. In the beginning of treatment, then after 6 months and after 12 months. 5. Duration of Study: 24 Months. 6. Duration of each case: Each case will be followed up for a period of 12 months. 7. Duration of each follow-up: once in a month or depending on the requirement of the individual case.

data collection instruments: 1 Screening form 2. Written Informed Consent Form. 3. Standardized Case Record. 4. Investigation – CBC, SR. FERRITIN, SR. IRON, SR. TRANSFERRIN, TIBC.

data collection method - 1 Screening of subjects 2. Written Informed Consent will be taken. 3. The detailed Homeopathic case taking will be carried out. 4. Investigation – CBC, SR. FERRITIN, SR. IRON, SR. TRANSFERRIN, TIBC. In the beginning of treatment, then after 6 months and after 12 months. 5. Duration of Study: 24 Months. 6. Duration of each case: Each case will be followed up for a period of 12 months. 7. Duration of each follow-up: once in a month or depending on the requirement of the individual case.

data analysis method - statistical analysis : Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. ï‚· Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov Smirnov test. Depending on the normality of data, statistical tests will be determined. ï‚· For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used. ï‚· Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test. ï‚· Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. ï‚· Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

mechanism to assure the quality of the study - The study quality will be assured by : 1. Self check, self monitoring and standard tools will be used and written procedure by the primary researcher, and the other team including lab technician and laboratory staffs will be done. 2. The selection bias will be minimized by a random allocation through computer generated sequences. 3. Blood investigation will be done by standard authentic laboratory. 4. Transparent project planning, documentation, processing and analysis of the data: we;;l documented data and usage of the standardized case record. 5. Data will be stored in physical as well as electronic forms in more than one device to assure the safety of storage of records.6.Placebo group safety: They can take symptomatic treatment during the research study. Eg. They can consult gastroenterologist if suffering from GI bleeding, nephrologist for anaemia of chronic disease, hematologist if bone marrow disorder, gynecologist if intractable Menorrhagia and cardiologist if severe anaemia leads to angina, heart failure or myocardial infarction.

ethical consideration - Ethical Consent from Institutional Ethical Committee has been obtained.