| CTRI Number |
CTRI/2024/07/069704 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand role of calcarea carbonicum 200C to treat increased cholestrol. |
|
Scientific Title of Study
|
A Clinical Study on the Effectiveness of Calcarea carbonicum 200C in Hypertriglyceridemia. |
| 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 Naga Suvedha S |
| Designation |
Postgraduate student |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
3rd Floor College Building, Department of Practice of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari, Tamil Nadu.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
6380210277 |
| Fax |
|
| Email |
suvedhabio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Ajayan |
| Designation |
Professor and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
3rd Floor College Building, Department OF Practice of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist,Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995605094 |
| Fax |
|
| Email |
tajayandr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Ajayan |
| Designation |
Professor and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
3rd Floor College Buidling, Department of Practice Of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995605094 |
| Fax |
|
| Email |
tajayandr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution-Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist, Tamil Nadu-629161, India |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Kulasekharam, Kanniyakumari, Tamil Nadu-629161, India. |
| Type of Sponsor |
Private 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 Naga Suvedha S |
Sarada Krishna Homoeopathic Medical College Hospital |
Room No 104, 3B Unit-Practice of Medicine Outpatient Department and Inpatient Department of Practice of Medicine Kanniyakumari
Kanniyakumari
TAMIL NADU |
6380210277
suvedhabio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E781||Pure hyperglyceridemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CALCAREA CARBONICUM 200C |
Calcarea Carbonicum 200 will be administered once in a month through orally. Regular follow-up will be maintained monthly once. The case will be studied for a period of 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in between 30 – 60 years of age.
Both male and female.
Patients having triglyceride level 150 – 499 mg / dl.
Patient who has no history of any systemic illness.
Patient who are not under medication for Hypertriglyceridemia.
Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patient below 30 years and above 60 years.
Patient with history of cardiac complaint.
Patient with any known severe systemic illness (cancer, hepatic diseases, diabetes, any abnormality
in LFT and RFT).
Pregnant and lactating mothers.
Patient under medication for Hypertriglyceridemia.
Patients unable or unwilling to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
From this study the effectiveness of calcarea carbonica 200 in decreasing the triglycerides level will be known
through pre and post lipid profile test with statistical analysis.
|
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 which is the key issue for cardiovascular disease but its prevention and treatment remains as a prophylaxis. Among the treatment of lipid disturbance treating elevated triglycerides remains less robust than that for treating elevated low-density lipoprotein–cholesterol. In conventional system of medicine, the patients are asked to take long term medications which don’t gives permanent relief. Whereas in homoeopathy the patient suffering is considered as a whole, the importance is given to mode of living and habits, occupation, mental health etc are considered while treating the patient. Therefore, homoeopathy not only decreases the serum cholesterol levels but it also body’s defective tendency to hold excess of fat, improves liver fat metabolism, detoxify the body, and also enhance the immune system. According to various researches it is found that calcium supplements were effective in lowering the lipid levels. From CALCAREA CARBONICA - THE COLLECTOR OF DAYS & FOSSILS by Peter Morrellin the human body, calcium manifests as the skeleton and teeth, but it is also important in fat metabolism, linking it to Vitamin D. Thus, this study aims to delineate the effect of calcarea carbonica in lowering triglyceride level. After detailed case taking medicine will be prescribed, regular follow up will be maintained for period of six months and monthly one dose will be given based on the requirement and the improvement will be further assessed by regular monitoring of triglyceride level for three months once. If improvement is noted repetition will be stopped. And in case of any acute disease medicine will be given as per requirement. |