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CTRI Number  CTRI/2024/03/063729 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Studying antithyroglobulin antibodies in hashimotos disease with murphy repertory 
Scientific Title of Study   A clinical study in assessing the antithyroglobulin antibody levels in hashimotos thyroiditis using Murphy repertory 
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 Reshma JR 
Designation  Pg Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari District Department of Repertory 2nd floor Room no 301

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9597857575  
Fax    
Email  subikshajr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sathish Kumar V 
Designation  Professor and Head Department of Repertory 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari District Department of Repertory 2nd floor Room no 301
nil
Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443558483  
Fax    
Email  hodcr@skhmc.org  
 
Details of Contact Person
Public Query  
Name  Dr Reshma JR 
Designation  Pg Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari District Department of Repertory 2nd floor Room no 301

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9597857575  
Fax    
Email  subikshajr@gmail.com  
 
Source of Monetary or Material Support  
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu- 629161  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Reshma JR  Sarada Krishna Homoeopathic Medical College  Kulasekharam Kanniyakumari District Department of Repertory 2nd floor Room no 301
Kanniyakumari
TAMIL NADU 		 9597857575

subikshajr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sarada Krishna Homoeopathic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E063||Autoimmune thyroiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine  1. Case taking, medicine selection and administration will be done according to homoeopathic principle. 2. Homeopathic medicine will be selected with the help of Homoeopathic medical repertory according to the symptoms presented by the patient at the time of clinical interview. 3. The potency of Homoeopathic medicine administered will be in centesimal or LM potency. 4. The frequency is twice a day, using the oral route of administration, with an intervention duration of two weeks. Repetition of medicine will be based on the improvement of the patient. 5. Follow-up assessment will be done successively every month for a period of 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients suffering from Hashimoto’s thyroiditis with elevated TSH, anti-Thyroglobulin Ab.
Female patients will be included.
Patients between 18-60 years of age.
 
 
ExclusionCriteria 
Details  Pregnant, post-partum and nursing women will be excluded.
Known cases of other autoimmune disorders.
Known cases of thyroid malignancy.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The efficacy of Homoeopathic medicines in reducing the Anti-thyroglobulin antibody level in Hashimoto’s thyroiditis will be proved before and after an interval of 6 months of the treatment.
Cases will be evaluated for age, sex, occupation, symptoms presented, values of anti-thyroglobulin antibody (anti-Tg), thyroid peroxidase antibodies and TSH will be considered for statistical analysis and to derive the result, thereby validating the study.  		 The efficacy of Homoeopathic medicines in reducing the Anti-thyroglobulin antibody level in Hashimoto’s thyroiditis will be proved before and after an interval of 6 months of the treatment.
Cases will be evaluated for age, sex, occupation, symptoms presented, values of anti-thyroglobulin antibody (anti-Tg), thyroid peroxidase antibodies and TSH will be considered for statistical analysis and to derive the result, thereby validating the study.  
 
Secondary Outcome  
Outcome  TimePoints 
The symptomatic improvement of the patient with hypothyroidism assessed by Zulewski clinical score will reveal the efficacy of Murphy repertory in the treatment of Hashimoto’s thyroiditis.
An alphabetical repertory will be constructed on thyroid disorders.  		 Medicines given will be observed for 2 weeks consecutively for 6 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)   20/03/2024 
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="0"
Months="6"
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  

This study aims to assess the effectiveness of homeopathic medicines in reducing anti-thyroglobulin antibody levels in patients diagnosed with Hashimoto’s thyroiditis, an autoimmune condition leading to hypothyroidism. With a focus on a sample size of 30 cases from outpatient and inpatient departments, demographic data, symptoms, and laboratory values including thyroid-stimulating hormone (TSH) and anti-thyroglobulin antibody (anti-Tg) levels will be evaluated. The intervention involves homeopathic remedies based on individual symptomatology. The primary objective is to analyze the impact of homeopathic treatment on anti-thyroglobulin antibody levels, with secondary objectives including the assessment of symptomatic improvement using Zulewski clinical score and the construction of an alphabetical repertory on thyroid disorders. Expected outcomes include demonstrating the efficacy of homeopathic medicines in reducing thyroglobulin antibody levels, symptomatic improvement, and the development of a comprehensive repertory for thyroid disorders.

 
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