| CTRI Number |
CTRI/2025/04/084294 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Siddha Medicine
(Maruthampattai chooranam) for Dyslipidemia among Outpatients attending Ayothidoss pandithar hospital. |
|
Scientific Title of Study
|
An Open Phase II Clinical trial to evaluate the therapeutic effectiveness of Maruthampattai chooranam in the management of Athimetham(Dyslipidemia) 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 ASWINI J V |
| 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 |
9488924048 |
| Fax |
|
| Email |
aswinijv81298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T LAKSHMIKANTHAM |
| Designation |
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 |
9025575185 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
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 J V ASWINI |
Ayothidoss Pandithar Hospital |
Room no 7/8,
Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Chennai
TAMIL NADU |
9488924048
aswinijv81298@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 |
Maruthampattai chooranam |
Maruthampattai chooranam-2 grams Bd with Hotwater, Oral route of administration for the period of 90 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants attending Obesity Special OPD will be screened for Dyslipidemia.
2.Participants with newly identified Dyslipidemia will be included.
3.Participants having any one or all of the following altered lipid levels will be selected. (ATP III Guidelines, NCEP-National Cholesterol Education Program)
Total cholesterol more than 200mg/dl
LDL cholesterol more than 130mg/dl
HDL cholesterol less than 40 mg/dl
Triglyceride more than 150 mg/dl
|
|
| ExclusionCriteria |
| Details |
1.Participants with chronic kidney diseases.
2.Participants with Active vascular disease
(e.g. Unstable angina, stroke).
3.K/C/O coronary heart disease
4.K/C/O Liver diseases such as Hepatitis, Cirrhosis.
5.K/C/O Thyroid dysfuntion.
6.Chronic Smokers/Alcoholics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of the Study will be assessed by comparing the changes in the Lipid Profile before and after Treatment. |
at Baseline and 12 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/04/2025 |
| 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="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 Medicine is one of the most ancient systems of Medicine in the World. It is mainly based on three vital humours namely Vazhi, Azhal and Iyam. It contributes in treating the disease as well as play an important role in rejuvenating the body and mind. One of the Special therapy in Siddha System of Medicine is use of Single herbal therapy for various Diseases.According to Siddha literature, Human body is mainly composed of seven udal thathukal. Kozhuppu thathu is one among them. As per TV Sambasivam Pillai dictionary, the word “Athi” means Athigam or Miguthi and the word “Metham” means Kozhuppu. The disease ATHIMETHAM may be correlated to Dyslipidemia (ICD-10 Code E78. 5). According to Siddha Text, Principles of Diagnosis in Siddha, Kozhuppu helps the function of each organ of the body by making them greasy. Increase in Kozhuppu thathu of the body causes Tiresomeness, dyspnoea even during very light work. Increase in Kozhuppu thathu also leads to formation of hanging muscles on the buttocks, the chest, stomach and the thighs . It relates to Obesity. The "Health of the Nation 2023" report has revealed a 50% rise in obesity rates and an 18% increase in Hyperlipidemia among Indians from 2019 to 2022.Dyslipidemia (Hyperlipoproteinemia/Hyperlipidemia) is a condition characterized by an elevation of any or all parameters of lipid profile or lipoprotein levels in the blood. There are several risk factors associated with Hyperlipidemia such as Diabetes, Obesity, Hypertension, Hypothyroidism, sedentary life style, fatty/oily diets, excess alcohol intake and smoking . The World Health Organization (WHO) reports that high cholesterol contributes to 56% of Global heart disease and 18% Global stroke events. It responsible for 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 .In 2023, 75% of patients still exceed the target levels for low-density lipoprotein cholesterol (LDL-C), making hypercholesterolemia both the most prevalent and poorly managed Cardiovascular risk factor. With early diagnosis, we could potentially prevent several million deaths.In Siddha system of Medicine, there was large collection of herbal medicines treating various disease. Evidence based research supports the role of Siddha Medicinal plants in reducing Dyslipidemia. Availability of a wide range of allopathic hypolipidemic like statins and fibrate, they have not gained popularity due to their significant side effects such as rhabdomyolysis, hyperuricemia and hepatotoxicity. Considering the wide magnitude of lipid disorders and the absence of promising remedies with safety in Conventional systems, the suffering population is turning towards other systems of Medicine for safe and effective remedies. Maruthampattai had various chemical constituents such as Polyphenols, Flavonoid, tannins, etc which helps in treating hyperlipidemia.This study aims to evaluate the therapeutic effectiveness of Siddha Medicine Single herbal drug by name “MARUTHAMPATTAI CHOORANAM” in the management of ATHIMETHAM (Dyslipidemia). OBJECTIVE: To evaluate the therapeutic effectiveness of Siddha Medicine “MARUTHAMPATTAI CHOORANAM ” in the management of Athimetham (Dyslipidemia) by comparing the changes in the Lipid profile before and after treatment. STUDY TYPE: Interventional study STUDY DESIGN: Open Phase II Clinical Trial STUDY PLACE: Department of Maruthuvam, OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram sanatorium, Chennai – 47. STUDY PERIOD: 18 months SAMPLING METHOD: Consecutive sampling SAMPLE SIZE: 30 Patients INCLUSION CRITERIA: - Age group: 30-60 years .
- Sex: Male, Female, Transgender.
- Participants attending Obesity Special OPD will be screened for Dyslipidemia.
- Participants with newly identified Dyslipidemia will be included.
- Participants having any one or all of the following altered lipid levels will be selected. (ATP III Guidelines, NCEP-National Cholesterol Education Program)
Total cholesterol more than 200mg/dl LDL cholesterol more than 130mg/dl HDL cholesterol less than 40 mg/dl Triglyceride more than 150 mg/dl EXCLUSION CRITERIA:- Participants with chronic kidney diseases.
- Participants with Active vascular disease (e.g. Unstable angina, stroke).
- K/C/O coronary heart disease.
- K/C/O Liver diseases such as Hepatitis, Cirrhosis.
- K/C/O Thyroid dysfuntion.
- Chronic Smokers/Alcoholics.
OUTCOME OF TREATMENT [Time Points-90 days]: The outcome of the Study will be assessed by comparing the changes in the Lipid Profile before and after Treatment. RESUTS AND DISCUSSION: The results will be statistically analysed and reported. KEYWORDS: Dyslipidemia,Maruthampattai chooranam,Athimetham |