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CTRI Number  CTRI/2024/05/067237 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment for increased levels of lipid in blood.  
Scientific Title of Study   Clinical Study on The Utility of Individualized Homoeopathic Medicines in The Management of Dyslipidemia Using Repertorium Homoeopathicum Syntheticum.  
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 Pankaj Soni 
Designation  Postgraduate trainee 
Affiliation  State National Homoeopathic Medical College And Hospital, Lucknow 
Address  Department of Case Taking and Repertory State National Homoeopathic Medical College And Hospital 1-viraj khand Gomti Nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7838518038  
Fax    
Email  Sonipankajsp0101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank Parashar  
Designation  Professor 
Affiliation  State National Homoeopathic Medical College And Hospital, Lucknow 
Address  State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9300493521  
Fax    
Email  shashankgoga@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Soni 
Designation  Postgraduate trainee 
Affiliation  State National Homoeopathic Medical College And Hospital, Lucknow 
Address  Department of Case Taking and Repertory State National Homoeopathic Medical College And Hospital 1-viraj khand Gomti Nagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7838518038  
Fax    
Email  Sonipankajsp0101@gmail.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow 226010 
 
Primary Sponsor  
Name  Dr Pankaj soni 
Address  Department of Case Taking and Repertory State National Homoeopathic Medical College And Hospital 1-viraj khand Gomti Nagar Lucknow 
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 Pankaj Soni  State National Homoeopathic Medical College and Hospital Lucknow  OPD no-10,Department of Case Taking and Repertory State National Homoeopathic Medical College And Hospital 1-viraj khand Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH 		 7838518038

Sonipankajsp0101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic medicines with lifestyle modification.   Intervention planned as after obtaining consent, and proper case taking of all enrolled patients will be done in a standardized case taking proforma which is being used in State National Homoeopathic Medical College and Hospital. Individualized Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Synthesis Repertory. Indicated Homoeopathic Medicine will be administered to the case or condition in required potency and doses depending upon the individual case. Medicines will be taken orally. Each case will be followed up at regular interval as per requirement preferably at a period of 15 days. Each patient will be studied for 1 year after enrollment in study. General (non-medicinal) management which includes appropriate diet, regimen and proper life style modification will be advised as and when required. Progress of patient will be assessed through laboratory findings of Lipid profile(National Cholesterol Education Programme classification) at an interval of 3 months and ORIDL Scale at an interval of 15 days.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient of age 25 year to 60 year of either sex.
2.Patient giving consent to participate.
3.Patients fulfilling the Diagnostic Criteria based on clinical presentation.
Diagnostic criteria
Dyslipidemia is characterized by fasting:
1.Total cholesterol-more than 200 mg/dl.
2.Low density lipoprotein more than 130 mg/dl.
3.Triglyceride-more than 150 mg/dl.
4.High density lipoprotein less than 40 mg/dl. 
 
ExclusionCriteria 
Details  1.Patient of age less than 25 years and above 60 years.
2. Continuous use of drugs that affect lipid metabolism.
3.Patient suffering from serious illness such as stroke, Myocardial infarction, chronic kidney disease and their complication.
4.Patient not willing to give consent.
5.Patients undergoing Allopathic medication for Dyslipidemia.
6.Self-reported immuno compromised state.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the changes in the value of Lipid profile before and after the Homoeopathic treatment using Repertorium Homoeopathicum Syntheticum in management of Dyslipidemia as per NCEP. (NATIONAL CHOLESTEROL EDUCATION PROGRAM)
Cholesterol Guidelines:
 		 3 months

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the quality of life in patients with Dyslipidemia using ORIDL. (Outcome
Related to Impact on Daily Living)
 		 15 days 
 
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)   20/05/2024 
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="1"
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   Dyslipidemia is the most important atherosclerotic risk factor. Review of population-based studies in India shows increasing mean total cholesterol levels. Recent studies have reported that high cholesterol is present in 25–30% of urban and 15–20% rural subjects. This prevalence is lower than high-income countries. The most common dyslipidemia in India is borderline high LDL cholesterol, low HDL cholesterol and high triglycerides.
The present study was therefore designed to attempt to evaluate the efficacy of a homoeopathic medicine in the treatment of Dyslipidemia.
At the end of study, it is expected that individualized homeopathic medicine selected with the help of Repertorium Homoeopathicum Syntheticum will show effective result in management of Dyslipidemia. The study will determine different causative factor related to Dyslipidemia and predict the outcome of individualized homeopathic medicine in improving the quality of life of patient. If the results will be positive, a certain group of remedies can be observed which are frequently indicated in cases of Dyslipidemia. There will be also improvement of mental health & behavior of the patient, with overall enhancement in the susceptibility & vitality of the patient.

 
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