FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
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.
 
Close