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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  
Name  Address 
NIL  NIL 
 
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  
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  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:
ï‚§ Patients with chronic kidney diseases, cardiovascular diseases
ï‚§ Active vascular disease (e.g. unstable angina, stroke like symptoms)
ï‚§ Patients with known liver diseases.
ï‚§ Pregnancy and lactation
ï‚§ 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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