| CTRI Number |
CTRI/2024/10/075389 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of unani herb Marzanjosh in high cholesterol |
|
Scientific Title of Study
|
Clinical Efficacy of Safoof Marzanjosh (Origanum majorana) in Hyperlipidemia - A Randomized Controlled Trial |
| 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.FIRDHAUS RUMANA.K |
| Designation |
P.G SCHOLAR |
| Affiliation |
Arignar Anna Government Hospital of Indian Medicine, chennai |
| Address |
GOVERMENT UNANI MEDICAL COLLEGE,OPD NO: 5M, DEPARTMENT OF MOALAJAT,
ARIGNAR ANNA GOVERNMENT HOSPITAL OF INDIAN MEDICINE CAMPUS,
ARUMBAKKAM,
CHENNAI.
Chennai TAMIL NADU 600106 India |
| Phone |
8608948698 |
| Fax |
|
| Email |
firdhausrumana98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR.MUBASHEERA BEGUM |
| Designation |
Associate Professor |
| Affiliation |
Arignar Anna Government Hospital of Indian Medicine |
| Address |
Department of Moalajat
Government Unani Medical College,
ARUMBAKKAM,
CHENNAI
Chennai TAMIL NADU 600106 India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR.FIRDHAUS RUMANA. K |
| Designation |
P.G SCHOLAR |
| Affiliation |
Arignar Anna Government Hospital of Indian Medicine |
| Address |
Department of moalajat,
Government Unani Medical College,
Arignar Anna Government Hospital of Indian Medicine campus,
Arumbakkam.
Chennai TAMIL NADU 600106 India |
| Phone |
8608948698 |
| Fax |
|
| Email |
firdhausrumana98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna Government Hospital of Indian Medicine,Arumbakkam,Chennai,600106 |
|
|
Primary Sponsor
|
| Name |
Firdhaus RUMANA K |
| Address |
GOVERMENT UNANI MEDICAL COLLEGE ,CHENNAI,600106 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrFirdhaus RumanaK |
Arignar Anna Government Hospital of Indian Medicine |
Department of Moalajat OPD and IPD Room no 5M ARUMBAKKAM CHENNAI 600106. Chennai TAMIL NADU |
8608948698
firdhausrumana98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT UNANI MEDICAL COLLEGE |
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 |
ATORVASTATIN |
ATORVASTATIN 10 mg OD for 45 days |
| Intervention |
MARZANJOSH[ORIGANUM MAJORANA] |
D0SE:three grams in a powdered form,FREQUENCY:thrice a day,ROUTE OF ADMINISTRATION:ORALLY along with water.TOTAL DURATION:45 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of Hyperlipidemia were identified with laboratory testing and having the values of plasma total cholesterol more than 200mg/dl, LDL-C less than 190 mg/dl, TG less than 499 mg/dl.
Known cases of Hyperlipidemia with less than five years of disease history
Known cases of type II Diabetes Mellitus, Hypothyroidism, obesity BMI less than 30
Age 30 to 60yrs and all gender. |
|
| ExclusionCriteria |
| Details |
Age less than 30 yrs and more than 60 yrs
Pregnancy, Lactation
Total Cholesterol more than 400
KNOWN HYPERTENSIVE CASES
Systolic above 180
Diastolic above 110 mm Hg
Malignancies, CAD, TB, AIDS, and other comorbidities such as Ischemic Heart Disease, CCF etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in lipid levels |
Baseline,45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
24/10/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Unani system of medicine is one of the oldest systems of medicine which is practiced worldwide as holistic, preventive and curative medicine.In Unani Medicine, humours (Akhlat) play a vital role in maintenance of health; imbalance of their proportion either qualitative or quantitative can cause disease. Akhlat refers to the body fluids under a wider perspective in the Unani Medicine based upon theory of humors, which presupposes the presence of four humors in the body: dam (blood), balgham (phlegm), safra (yellow bile), and sawda (black bile), and human body is made of ten types of Aza_e_muffarada of which Shahm (Fat) is one of the important constituents. Unani literature has classified Shaham (Fat) under various categories like Sameen and Rivaaj1. Unani system has mentioned a number of functions of Shaham which corelates with modern system of medicine such as it gives energy and creates heat, helps to store energy, gives shape and protects our vital organs.Lipids(fat) are water insoluble molecules that are transported in protein capsule, which determines its density, the lipoproteins density determines the fate of the particle and its influence on metabolism. Plasma lipoprotein levels are major modifiable risk factors for cardiovascular disease. Increased levels of atherogenic lipoproteins (especially LDL) contribute to the development of atherosclerosis. LDL-C (Low density Lipoproteins) The cost of management of hyperlipidemia throughout the world is high.In 2010, the estimated global cost of treatment of Hyperlipidemia was USD 863 billion, which is expected to increase to USD 1044 billion by the year 203010. But in Unani System of Medicine there are plenty of potential herbal drugs which are safe and cheaper in comparison with modern drugs. Hence an attempt is made to explore the abundant resources of Unani Medicine in management of Hyperlipidemia. |