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
|
|
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
|
|
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. |