| CTRI Number |
CTRI/2024/06/069396 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on siddha medicine (karunjeeeraga chooranam and silasathu parpa mathirai) for Hyperlipidemia among outpatients attending ayothidoss pandithar hospital |
|
Scientific Title of Study
|
An Open Clinical trial to evaluate the therapeutic efficacy of selective Siddha medicine in the management of Hyperlipidemia among outpatients attending Ayothidoss Pandithar Hospital, National Institute Of Siddha |
| 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 Megha S |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Chennai TAMIL NADU 600047 India |
| Phone |
6382721141 |
| Fax |
|
| Email |
meghadijo1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Tambaram Sanatorium, Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Siddha |
| Address |
Room no 7/8, Department of maruthuvam, National Institute of Siddha,Tambaram Sanatorium, Chennai-47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S MEGHA |
Ayothidoss Pandithar Hospital |
Room no 7/8, Department ofMaruthuvam, National Instituteof Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU Chennai TAMIL NADU |
6382721141
meghadijo1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF SIDDHA, CHENNAI-600047 |
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 |
Karunjeeraga Chooranam
Silasathu Parpa Mathirai |
Karunjeeraga Chooranam- 2 gms bd with honey for 48 days
Silasathu Parpa Mathirai- 2 tabs bd with ghee for 48 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Increased levels of any one of the lipid profile
according to WHO guidelines.
2.Patient who was already diagnosed as
hyperlipidemia. |
|
| ExclusionCriteria |
| Details |
1.Patients with chronic kidney diseases,
cardiovascular diseases
2.Active vascular disease (e.g. unstable angina,
stroke like symptoms)
3.Patients with known liver diseases.
4.Pregnancy and lactation
ï‚§ Patients with any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in values of lipid profile will be assessed before and after treatment. |
Reduction in values of lipid profile will be assessed after the period of 48 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
02/07/2024 |
| 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="0" 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
|
BACKGROUND: Siddha system is one of the ancient systems of medicine in the world. It is mainly based on three vital humours named Vali, Azhal and Iyam. The inimitable of this system is efficacy of drugs with various adjuvant evidenced for assortment of diseases. Siddha system not only deals with diseases, treatment, prevention, cure and also lifestyle. HYPERLIPIDEMIA is one of the life style modification diseases in our country. Hyperlipidemia which is increased levels of lipids. Hyperlipidemia includes both hypercholestremia and hypertriglyceridemia. Although it does not show any symptoms, it lay concrete for many diseases –cardiovascular diseases and stroke are very common due to atherosclerosis. Hyperlipidemia is one of the major risk factor for coronary heart disease (CHD) a major leading cause of mortality in developed countries, will soon become the pre-eminent health problem worldwide. Recent epidemiological studies reveals that there is an increase in lipid levels globally. There is wide variation in the prevalence, awareness, and treatment of hyperlipidemia between populations. According to WHO MONICA PROJECT the prevalence of hypercholestremia varied across populations from 3% to 53% in men, and from 4% to 40% in women. Awareness of hypercholestremia varied from 1% to 33% in in men, and from 0% to 31% in women. In most populations, over 50% of men and women on lipid lowering drugs. The World Health Organization (WHO) reports that high cholesterol contributes to 56% of cases of coronary heart disease worldwide and causes more than 4 million deaths each year. In most parts of the world, the number of female deaths attributed to high cholesterol is slightly higher than the number of male deaths. India is a developing country has been showing an increase in the incidence of hyperlipidemia, for the past few decades. In young adult Indian population the prevalence dyslipidemia was observed to be higher in males than in females. Among particicipants who had a total cholesterol (TC) concentration 200mg/dl, 38.7% were males and 23.3% were females. High density lipoprotein (HDL-C) was abnormally low in 64.2% males and 33.8% in females. The increase of prevalence of hypercholestremia and hypertriglyceridemia was more prominent in 31-40 age group than in 30 age group. Another epidemiological study in South India conducted by Sri Ramachandra University, Chennai, mentioned that the prevalence of abnormal serum lipid levels was more prominent in the age group of 40-59 years in both sexes. High levels of triglycerides were identified in 41.5% and very high levels in 1.2%. LDL –cholesterol levels were high in 32.9% and very high in 7.45%, and a higher total cholesterol were found in 25.35%. HDL-cholesterol levels were found to be low in 34.35%. It is the right time for the measures to be taken for this disease. Many Siddha medicines have been indicated for increased level of lipids. Several indigenous plants have been claimed to possess hypolipidemic and hypocholesteremic properties that may be beneficial to reduce the risk of cardiovascular diseases. OBJECTIVE: To evaluate the therapeutic effectiveness of siddha formulation “KARUNJEERAGA CHOORANAM, SILASATHU PARPA MATHIRAI†in the management of HYPERLIPIDEMIA by improvement in lipid profile among out patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha. STUDY DESIGN : An Open Clinical Trial STUDY PLACE : Maruthuvam department OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium Chennai-47 STUDY PERIOD : 6 months SAMPLE SIZE : 20 patients INCLUSION CRITERIA:  Age group: 20-60 years  All Gender  Increased levels of any one of the lipid profile according to WHO guidelines.  Patient who was already diagnosed as hyperlipidemia.  Patient who are willing to provide blood for investigations before and after treatment. EXCLUSION CRITERIA:  Patients with chronic kidney diseases, cardiovascular diseases  Active vascular disease (e.g. unstable angina, stroke like symptoms)  Patients with known liver diseases.  Pregnancy and lactation  Patients with any other serious illness. OUTCOME OF TREATMENT: Reduction in values of lipid profile will be assessed before and after treatment. RESULTS AND DISCUSSION: The results will be statistically analysed and reported. KEYWORDS: Hyperlipidemia, Karunjeeraga chooranam, Silasathu parpa mathirai
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