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CTRI Number  CTRI/2020/09/028106 [Registered on: 28/09/2020] Trial Registered Prospectively
Last Modified On: 27/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of Herbal Unani Medicine on unhealthy levels of one or more kind of lipid (fat) in blood. 
Scientific Title of Study   Efficacy of Unani formulation in Dyslipidemia- An open labelled interventional clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Faisal habib 
Designation  PG SCHOLAR  
Affiliation  NATIONAL INSTITUTE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91

Bangalore
KARNATAKA
560091
India 
Phone  9267438329  
Fax    
Email  faisalhabib0571@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Mansoor Ahmed Siddiqui 
Designation  Professor 
Affiliation  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91

Bangalore
KARNATAKA
560091
India 
Phone  9448124054  
Fax    
Email  mansoorsiddiquidr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Mansoor Ahmed Siddiqui 
Designation  Professor 
Affiliation  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91

Bangalore
KARNATAKA
560091
India 
Phone  9448124054  
Fax    
Email  mansoorsiddiquidr@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91  
 
Primary Sponsor  
Name  NATIONAL INSTITUE OF UNANI MEDICINE 
Address  NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91  
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 
Faisal habib  NATIONAL INSTITUTE OF UNANI MEDICINE  OPD/IPD of Dept. of Moalajat NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
Bangalore
KARNATAKA 
9267438329

faisalhabib0571@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E788||Other disorders of lipoprotein metabolism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Unani formulation   Test drug will be given orally in a dose of 4.5 grams powder with lukewarm water in morning in an empty stomach. By giving the instruction to patients- NOT to take any meal up to 30 mins after oral administration of powder.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  BMI between 25-35 kg/m2

A) LDL-cholesterol:130-159mg/dl(Borderline high)8
B)Totalcholesterol:200-239mg/dl(Borderline High)8
C)HDL-cholesterol:<40mg/dl(low) &>60mg/dl(High)8
D)Serum Triglycerides:200-499mg/dl(High)8
Patient who will give consent and able to do follow up.
 
 
ExclusionCriteria 
Details  1. Patient below the age of 20 years and above the age of 55 years
2. Pregnant and lactating mothers
3. Patient with systemic illness such malignancy, liver, kidney dysfunction, T.B. etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effects on TGL, HDL, LDL, VLDL, TC (normal/decrease).  0th day and 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
BMI, Waist Circumference, Hip and Waist Ratio, Weight in Kgs  0th day, 14th day, 28th day, 42nd days. 
 
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)   05/10/2020 
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   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The dyslipidaemia is a state of abnormal levels of lipids (e.g. triglycerides, cholesterol and/or fat Phospholipids) in the plasma1. It is characterised as hypercholesterolemia, low level of high density of

lipoproteins (HDL) and triglyceridemia.

Dyslipidemia is the major risk factor for the cardiovascular disease and is estimated to cause 2.6 million death and 29.7 million disability adjusted life year’s globally. According to the World Health Organisation, the prevalence of dyslipidemia in the south east Asia (30%), and the western pacific (36.7%) were much lower than that in Europe (53.7%) and the Americas (47.7%). However, the prevalence of it across the Asia pacific region varies.If dyslipidemia not monitored and left untreated, affects the overall health status of an individual which may lead to overall hardening of the arteries in the later years of life. Similarly atherosclerosis is a condition described in conventional medicine occurs due to excess deposition of lipids in vessels and finally it can lead to MI and sudden death .

Multiple epidemiologic studies have demonstrated a strong relationship between plasma levels of LDL-C and CHD. A direct connection between plasma cholesterol levels and the atherosclerotic process was made in humans.In modern system of medicine, the dyslipidemia is treated by following ways: Life style modification, exercise, diet, revascularisation and medication. Statins are the cornerstone of lipid lowering treatment. Several different types of statins with different pharmacological structures are now available as well as other lipids lowering drugs, plasma lipids levels, particularly those of LDL often are not optimally lowered to reach the recommended levels

Keeping this view, the adverse effects of statins, various experts of different fields are exploring the methods to control the effects of lipids abnormalities. In Unani System of Medicine various formulation has been indicated for the condition like dyslipidemia. The management is described under the caption of dasoomat-e-dam, therefore principle of treatment of dyslipidemia given on the same line of treatment of dasoomat-e-dam. The Unani formulation constitute following drugs which will be given in the form of powder: Badyan, Zeerakirmani, Bora armani, Suddab, Marzanjoshkhushk, Lukmaghsool, Nankhwah.

 
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