To know the effect of Homoeopathic Medicine as a supportive therapy on altering blood parameters (CBC,SR IRON, SR FERRITIN, SR TRANSFERRITIN, TIBC) in mild to moderate grades of anemia in young girls along with iron supplements.
Scientific Title of Study
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.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr. Sonali Parasnath Chauhan
Designation
assistant professor
Affiliation
Dr. M.L. Dhawale Memorial Homoeopathic Institute
Address
Dr. M.L. Dhawale Memorial Homoeopathic Institute, 306, room no, department of Paediatric, academic building, palghar boisar road, opposite to ST workshop, 401404, palghar, Maharashtra, India.
Thane MAHARASHTRA 401404 India
Phone
09768967476
Fax
Email
drsoch82@gmail.com
Details of Contact Person Scientific Query
Name
Dr. C R Goda
Designation
Professor and HOD of paediatric department
Affiliation
Dr. M. L. Dhawale Memorial Homoeopathic insititute
Address
Dr. M.L. Dhawale Memorial Homoeopathic Institute, 306, room no, department of Paediatric, academic building, palghar boisar road, opposite to ST workshop, 401404, palghar, Maharashtra, India.
Thane MAHARASHTRA 401404 India
Phone
9322882918
Fax
Email
sujchan18@gmail.com
Details of Contact Person Public Query
Name
DR SONALI PARASNATH CHAUHAN
Designation
Ph D SCHOLAR
Affiliation
Dr. M.L. Dhawale Memorial Homoeopathic Institute,
Address
Dr. M.L. Dhawale Memorial Homoeopathic Institute, 306, room no, department of Paediatric, academic building, palghar boisar road, opposite to ST workshop, 401404, palghar, Maharashtra, India.
Thane MAHARASHTRA 401404 India
Phone
09768967476
Fax
Email
drsoch82@gmail.com
Source of Monetary or Material Support
Dr. M. L. Dhawale Memomrial HOmoeopathic Institute, Palghar, Maharashtra 401404, India
Dr. M. L.D. Memorial Homoeopathic Institute and Research Centre
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D508||Other iron deficiency anemias,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Homoeopathic constitutional remedy based on similia similibus curanter of the individual along with iron supplements.
Dose of homoeopathic constitutional remedy would be chosen based on individual susceptibility, frequency of dose would be once in 2 weeks or as if required, role of administration of medicine would be oral route, duration of medicine would be for one year. iron supplement dose and frequency as if indicated, oral route of administration and duration is for one year
Comparator Agent
Homoeopathic placebo along with iron supplement.
homoeopathic placebo single dose, once in 2 weeks or daily, oral route of administration, duration is for one year.
iron supplement dose and frequency as if indicated, oral route of administration and duration is for one year.
Inclusion Criteria
Age From
10.00 Year(s)
Age To
19.00 Year(s)
Gender
Female
Details
Suffering from mild to moderate grades of iron deficiency anaemia
Iron deficiency anemia with altered blood parameters (CBC SR IRON SR
FERRITIN SR TRANSFERRIN TIBC)
ExclusionCriteria
Details
1. Pregnant adolescent girls.
2. Suffering from known chronic systemic illness, other types of iron deficiency
anaemia. E.g. Thalassemia, Sickle Cell Anemia, Hemochromatosis.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Homoeopathic similimum is effective 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.
time points for blood investigation are 3 months, 6 months and 12 months.
Secondary Outcome
Outcome
TimePoints
Homoeopathic similimum helps in modulating blood parameters in cases of mild to moderate anemia in adolescent girls
Time points for blood investigation 3 months, 6 months & 12 months.
To determine the common groups of remedies used in iron deficiency anaemia with
altered blood parameters (CBC, SR. IRON, SR. FERRITIN, SR. TRANSFERRIN,
TIBC) in adolescent girls.
. To determine role of susceptibility in mild to moderate grades of iron deficiency
anaemia with altered blood parameters (CBC, SR. IRON, SR. FERRITIN, SR.
TRANSFERRIN, TIBC) in adolescent girls
time points for follow up are 15 days or as when required.
Target Sample Size
Total Sample Size="104" Sample Size from India="104" 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)
10/10/2024
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="2" Months="0" 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 - YES
What data in particular will be shared? Response (Others) - Lab reports of CBC, Sr Ferritin, TIBC, Sr Transferrin, Sr Iron estimation levels, before and after treatment will be shared to explain the improved and not improved results.
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
Who will be able to view these files? Response - Anyone
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [drsoch82@gmail.com].
For how long will this data be available start date provided 01-12-2024 and end date provided 29-07-2025? Response - Immediately following publication. No end date.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - Nil
Brief Summary
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.  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.  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.  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.  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.  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.