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CTRI Number  CTRI/2024/10/076094 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment in lower level thyroid disease in Females 
Scientific Title of Study   Efficacy of Thyroidinum using LM potency in managing Subclinical Hypothyroidism among females of reproductive age group  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruthikaa V 
Designation  PG scholar 
Affiliation  Vinayaka Mission Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine Opd room 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi Salem

Salem
TAMIL NADU
636308
India 
Phone  9952945822  
Fax    
Email  ruthikaavenkat04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J Antony Rozario 
Designation  Associate Professor  
Affiliation  Vinayaka Mission Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine Opd room 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi Salem

Salem
TAMIL NADU
636308
India 
Phone  9894431131  
Fax    
Email  rozee1234@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr J Antony Rozario 
Designation  Associate Professor 
Affiliation  Vinayaka Mission Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine Opd room 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi Salem

Salem
TAMIL NADU
636308
India 
Phone  9894431131  
Fax    
Email  rozee1234@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Mission Homoeopathic Medical College and Hospital Seeragapadi Salem Tamilnadu 636308 INDIA 
 
Primary Sponsor  
Name  Vinayaka Mission Homoeopathic Medical College and Hospital  
Address  NH47 Sankari Main Road Seeragapadi Salem Tamilnadu 636308 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil   not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruthikaa V   Vinayaka mission homoeopathic medical college and hospital  NH47 Sankari Main Road Seeragapadi Salem Tamilnadu 636308 INDIA
Salem
TAMIL NADU 		 9952945822

ruthikaavenkat04@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 Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine   Homoeopathic medicine will be prescribed based on symptom similarity and individualisation using LM potency medicine administered orally followup is taken in every 30 days once maximum period of treatment is 6 months  
Comparator Agent  nil   nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  The Patients of Reproducitve age group with elevated levels of TSH more than 4.0mlU/L and T3 T4 within normal limits  
 
ExclusionCriteria 
Details  1 Cases with major complications and end organ involvement
2 Patients under treatment for Diabetes Hypertension PCOS Obesity
3 Autoimmune diseases like Hashimoto’s thyroiditis Graves’ disease SLE Rheumatoid arthritis which can affect the thyroid function 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptomatic improvement and decrease in TSH levels   At baseline and end of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that the proposed study will be useful in reducing the values of TSH to normal range  At the baseline and end of 6 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) 10/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Subclinical Hypothyroidism, classified as ICD-10 E02, affects approximately 7.5% of women and 2.8% of men globally, with a higher prevalence in India (10%) compared to the UK (2%) and the USA (4-6%).  Subclinical hypothyroidism (SCH) is common, defined as elevated TSH with normal T3 and T4 levels, due to lifestyle factors, affecting 4-10% of the general population, particularly older adults.

DRUG DESCRIPTION: 
Thyroidinum is indicated for hypothyroidism following acute illnesses, presenting with weakness, palpitations, low blood pressure, chilliness, and easy fatigue. It also has diuretic properties. It also can alleviate severe mania linked to myxedema and reduce symptoms, including appetite loss and facial swelling, while also benefiting heart function. Detailed case taking helps to find similimum. Mode of cure is rapid, gentle and permanent restoration of health. Through LM scale, remedies can be repeated and aggravation is less marked. LM scale is effective in both palliation and cure for chronic diseases.
 
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