| CTRI Number |
CTRI/2022/07/043957 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Individualized Homoeopathic medicines and Glycyrrhiza glabra mother tincture in the treatment of Hyperlipidemia |
|
Scientific Title of Study
|
A Synopsis On Effectiveness Of Individualized Homoeopathic Medicines And Glycyrrhiza Glabra Mother Tincture In The Treatment Of Hyperlipidemia: An Open Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Kumari |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block,
Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8294729274 |
| Fax |
|
| Email |
kumariakanksha15495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block,
Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block,
Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block, Sector 3, Salt lake, Kolkata, 700106 |
| 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 |
| Dr Akanksha Kumari |
National Institute of Homoeopathy |
Department of homoeopathic materia medica, OPD No.18, GE Block, Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL |
8294729274
kumariakanksha15495@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 |
| Comparator Agent |
Glycyrrhiza glabra mother tincture |
Comparator agent will be
specific homoeopathic medicine
Glycyrrhiza Glabra in mother ticture potency. Dose and frequency
depends on the condition of the patient. All patients shall be
prescibed homoeopathic
medicine Glycyrrhiza Glabra in
accordance with the direction
laid down by Dr. C. S. F.
Hahnemann in Organon of
medicine. Repetition and follow up shall be
done on the basis of
fundamental guidelines. The
follow-up will be done monthly
till 6 months from the baseline. |
| Intervention |
Individualized Homoeopathic medicine |
Intervention will be planned as administering indicated
homoeopathic medicines
selected on the basis of
homoepathic principles in centesimal potencies. Dose and
frequency depends on the
condition of the patient. All
patients shall be prescribed
homoeopathic medicine after
detailed case taking in
accordance with the direction
laid down by Dr. C. S. F.
Hahnemann in Organon of
medicine. Medicine selection,
potency selection, repetition and
follow up shall be done on the
basis of fundamental guidelines.
The follow-up will be done
monthly till 6 months from the
baseline. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients of both sexes and all religions.
b)Patients with Body Mass Index (BMI):
For females 25–30 and
For males 26–30.
c) Patients already undergoing to regular therapy for hyperlipidemia, provided the medication are stopped completely at least 2 weeks prior study entry.
d) Patients giving written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
a) Patients of age group below 30 and above 70 years.
b) Patients with BMI:
Females, BMI < 19,
Males, BMI < 20
c) Patients who will be too sick for consultation.
d) Patients of 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, pregnancy and lactation, substance abuse and/or dependence, self reported immunocompromised state, and patients availing homeopathic treatment for chronic disease within last 6 months.
e) Patients unwilling to take part or not giving consent to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It will be done using Serum lipid profile according to NCEP desirable cholesterol level as:
Total Cholesterol - 200mg/dl.
LDL Cholesterol - 130 mg/dl.
HDL Cholesterol - 50 mg/dl.
Triglycerides - 200 mg/dl.
|
At the baseline, 3rd month, and at 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will be done by assessing quality of life of patients on the basis of score obtained from COOP/WONCA Functional Assessment Chart. It measures six core aspects of functional status:
Physical fitness, Feelings, Daily activities, Social activities, Change in health and Overall health.
Each item is rated on this five-point ordinal scale ranging from 5 (‘no limitation at all’) to 5 (‘severely limited’). |
At the baseline, 3rd month, and at 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/07/2022 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyperlipidemia is considered as one of the major risk factors causing cardiovascular diseases (CVDs). It is commonly seen in above the age of 25 years. Researches showed that overall, 33.8% of the population presented any of the forms of hyperlipidemia, being more frequent in men (50.6%) than in women (28.8%). It causes Tuberous xanthomas in the Achilles tendon, hands, feet, elbows, and/or knees and Corneal arcus of the eye, Dyspnea, Paresthesia and Confusion. It does not have symptoms at all, but it can cause other symptomatic vascular disease, like coronary artery disease. Proper case taking is done and patients will be divided into two parallel arms. 50% patients will receive individualized homoeopathic medicines and 50% will receive Glycyrrhiza glabra mother tincture. Each enrolled case will be followed up monthly, Serum lipid profile will be done at the baseline, 3rd month, and at 6th month to assess/compare the change in serum lipid level. The assessment of the outcome of the treatment will be done using COOP/WONCA Functional Assessment chart gradation at the baseline, 3rd month, and at 6th month in particular level. |