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CTRI Number  CTRI/2025/06/089235 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Study on the Effect of Individualized Homoeopathic Medicine in Lowering Cholesterol Levels in Patients with Hypothyroidism 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicine in reducing total cholesterol level in patients with hypothyroidism-A Quasi experimental study 
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 SUSMITHA P 
Designation  Post Graduate Scholar,Dept of Practice of medicine 
Affiliation  National Homoeopathic Research Institute in Mental Health 
Address  National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O,Kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9605264420  
Fax    
Email  drsusparambil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BINURAJ SR 
Designation  ASSISTANT PROFESSOR,DEPARTMENT OF PRACTICE OF MEDICINE 
Affiliation  National Homoeopathic Research Institute in Mental Health 
Address  National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O,Kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9446106525  
Fax    
Email  drbinurajsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr BINURAJ SR 
Designation  ASSISTANT PROFESSOR,DEPARTMENT OF PRACTICE OF MEDICINE 
Affiliation  National Homoeopathic Research Institute in Mental Health 
Address  National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O,Kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9446106525  
Fax    
Email  drbinurajsr@gmail.com  
 
Source of Monetary or Material Support  
National homoeopathic research institute in mental health,sachivothamapuram p o, kottayam,Kerala,India pin 686532 
 
Primary Sponsor  
Name  Dr SUSMITHA .P 
Address  National homoeopathic research institute in mental health,sachivothamapuram p o, kottayam, kerala 686532 
Type of Sponsor  Other [(self)] 
 
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 SUSMITHA P  NATIONAL HOMOEOPATHIC RESEARCH INSTITUTE IN MENTAL HEALTH  OPD,IPD,Peripheral camps, department of practice of medicine,Kottayam
Kottayam
KERALA 		 9605264420

drsusparambil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUIONAL ETHICS COMMITTEE , NHRIMH.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic Medicine  After enrollment the cases will be repertorised. Depending on the susceptibility of the patient individualized homoeopathic medicine will be administered in centesimal potencies and minimum doses according to the homeopathic principles. medicine is administered orally Each case will be followed up for one year from the beginning of the study. Each case will be reviewed every month and whenever if necessary. Cases will be assessed according to the symptomatic improvement using MYMOP and Billewicz score, Investigations such as Total cholesterol and TSH will be repeated at baseline, 6th and 12th month. In acute complaints, if necessary, medicine will be prescribed based on the acute totality. Potency and repetition of the medicine can be changed in the follow-ups, according to the demand of the case. The above homoepathic intervention will be given for a period of twelve months  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants from 18- 65 years of age both Genders.
Participants having total cholesterol more than normal range
Participants having TSH level more than normal range. 
 
ExclusionCriteria 
Details  Pregnant women and lactating ladies.
Immunocompromised patients.
Participants under conventional medicine for hypercholesterolemia Cancer patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The reduction in total cholesterol level in patients with Hypothyroidism by
individualized homoeopathic medicine. 		 Baseline till the conclusion of the study (12 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in TSH after administration of individualized homoeopathic
medicine.
• symptomatic improvement after the administration of individualized
homoeopathic medicine in the patients using MYMOP & Billewicz score. 		 TSH -Baseline ,6th,12th.
Billewics score and MYMOP EVERY MONTH 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   Phase 2 
Date of First Enrollment (India)   30/06/2025 
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="12"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsusparambil@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a one-year prospective study conducted at NHRIMH, Kottayam, involving patients selected through screening and Billewicz scoring. After obtaining informed consent, individualized homeopathic treatment will be administered based on each patient’s susceptibility and disease severity. Monthly follow-ups will assess symptom improvement using MYMOP and Billewicz scores, while cholesterol and TSH levels will be monitored at baseline, 6 and 12 months. Acute complaints will be managed with appropriate homeopathic remedies, with adjustments in potency and repetition made as needed.

 
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