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CTRI Number  CTRI/2025/06/088284 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Homoeopathic medicines in management of abnormal levels of lipids in the blood among adults 
Scientific Title of Study   Effectiveness of Homoeopathic medicines in management of dyslipidemia among adults: A Non controlled experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2022/PHD/999  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrutika Sunil Gaikwad  
Designation  PhD Scholar 
Affiliation  Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic Materia Medica Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210

Mumbai (Suburban)
MAHARASHTRA
410210
India 
Phone  7387420707  
Fax    
Email  drshrutikag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neena Suresh Menon 
Designation  Professor 
Affiliation  Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic Materia Medica Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210

Mumbai (Suburban)
MAHARASHTRA
410210
India 
Phone  9892857785  
Fax    
Email  dr.neenasuresh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shrutika Sunil Gaikwad  
Designation  PhD Scholar 
Affiliation  Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic Materia Medica Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210

Mumbai (Suburban)
MAHARASHTRA
410210
India 
Phone  7387420707  
Fax    
Email  drshrutikag@gmail.com  
 
Source of Monetary or Material Support  
Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210 
 
Primary Sponsor  
Name  Dr Shrutika Sunil Gaikwad 
Address  Dr. G. D. Pol foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210 
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 Shrutika Sunil Gaikwad  YMT Homoeopathic Medical College and Hospital  Department of Homoeopathic Materia Medica Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 7387420707

drshrutikag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. G. D. Pol Foundation YMT Homoeopathic Medical College and Hospital Sector 4 Kharghar Navi Mumbai 410210  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E782||Mixed hyperlipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  individualized Homoeopathic medicine, intercurrent medicine, anti miasmatic medicine and mother tincture will be given as and when required after referring repertory and Homoeopathic Materia Medica. Will be administered orally for duration of 1 year after follow up of 1 month dosage and potency will be decided on susceptibility of patient 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Pre-investigated cases of dyslipidemia 
 
ExclusionCriteria 
Details  1. Already taking treatment for dyslipidemia
2. Known case of cardiovascular diseases and History of stroke
3. Immunocompromised patients
4. Pregnant and lactating females
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Lower Levels of LDL Cholesterol Triglycerides with Homoeopathic medicines  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Study frequently coming Homoeopathic medicines lowering levels of LDL, Cholesterol, Triglycerides  3years 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   07/06/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 [drshrutikag@gmail.com].

  6. For how long will this data be available start date provided 15-12-2028 and end date provided 15-07-2040?
    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 study is a non-randomised, experimental trial to assess efficacy of Homoeopathic medicines carefully selected after reportorization and refering Homoeopathic materia medica in lowering Cholesterol, Triglycerides and LDL levels in adults who are diagnosed with dyslipidemia. 
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