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CTRI Number  CTRI/2019/11/021930 [Registered on: 08/11/2019] Trial Registered Prospectively
Last Modified On: 08/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic medicines for elevated levels of fat in blood 
Scientific Title of Study   Efficacy of individualized homeopathic medicines in treatment of dyslipidemia: Double-blind, randomized, placebo-controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1242-8855  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Umesh Kumar 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8100628490  
Fax    
Email  dr.umesh3006@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Syed Afsar Ali 
Designation  Lecturer 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8101154060  
Fax    
Email  afsar.syed@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Syed Afsar Ali 
Designation  Lecturer 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake


WEST BENGAL
700106
India 
Phone  8101154060  
Fax    
Email  afsar.syed@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Umesh Kumar  National Institute of Homoeopathy  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL 
8100628490

dr.umesh3006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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 homeopathic medicines in centesimal potencies  Intervention is planned as administering individualized homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 20) of cane sugar, medicated with a single drop of the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with medicines, the intervention arm will be advised for dietary restrictions (low saturated fat, high fibre) and physical activity, that is Lifestyle modification (LSM) advice. Duration of therapy: 3 months. 
Comparator Agent  Placebo, indistinguishable in appearance from verum  Each dose of placebo shall consist of 6-8 globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised for dietary restrictions (low saturated fat, high fibre) and physical activity, that is Lifestyle modification (LSM) advice. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Newly diagnosed dyslipidemia patients not undergoing any therapy (LDLc level more than 100)
2. Age 18-65 years
3. Both sexes
4. Providing written informed consent 
 
ExclusionCriteria 
Details  1. Familial hypertriglyceridemia
2. Patients who are too sick for consultation, unable to read patient information sheet, unwilling to take part or not giving consent to join the study
3. Diagnosed cases of systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
4. Pregnancy and lactation
5. Substance abuse and/or dependence
6. Self-reported immune-compromised state, and
7. Undergoing homeopathic treatment for chronic disease within last 6 months. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Low density lipoprotein cholesterol (LDLc)  Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
VLDLc, HDLc, total cholesterol, triglycerides  Baseline, every month, up to 3 months 
Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)  Baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   18/11/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Results arising from the trial will be published in scientific journals 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Disorders of lipoprotein metabolism are collectively referred to as ‘dyslipidemia’. Many patients with dyslipidemia are at increased risk for atherosclerotic cardiovascular disease. Recently, in a short review of published homoeopathy research evidences on dyslipidaemia identified four preclinical, three observational studies, and two case records. There were positive leads in managing patients suffering from dyslipidaemia. However, more well-designed studies were warranted to generate effectiveness/efficacy of homeopathy. In order to detect the efficacy of individualized homeopathic medicines in treatment of dyslipidemia, this double blind, randomized (1:1), placebo-controlled, two parallel arms, clinical trial will be conducted on 92 patients at National Institute of Homoeopathy (NIH). Patients will be randomized to receive either individualized homeopathic medicines in centesimal potencies, or identical looking placebo. Irrespective of groups, all the randomized patients will be advised for dietary restriction (low saturated fat and high fiber) and regular exercises. The outcome measures - LDLc (primary), VLDLc, HDLc, total cholesterol, triglycerides, and MYMOP-2 (secondary) will be assessed at baseline, and every month, up to 6 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.

 
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