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CTRI Number  CTRI/2024/04/065396 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 30/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative evaluation of unani formulation with rosuvastatin in the management of dyslipidaemia 
Scientific Title of Study   A Randomized Clinical Study On Dyslipidaemia and Comparative Evaluation Of Unani Formulation With Rosuvastatin In Its Management  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Md Hamza Ahmad  
Designation  PG Scholar Department of Moalejat  
Affiliation  Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh  
Address  Department of Moalejat Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh Uttar Pradesh India

Aligarh
UTTAR PRADESH
202002
India 
Phone  9520364762  
Fax    
Email  hamzahmad0484@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Tanzeel Ahmad  
Designation  Professor  
Affiliation  Ajmal khan tibbya college Aligarh Muslim University Aligarh  
Address  Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college Aligarh Muslim University Aligarh Uttar Pradesh India

Aligarh
UTTAR PRADESH
202002
India 
Phone  948123337  
Fax    
Email  tanzeel1967@gmail.com  
 
Details of Contact Person
Public Query  
Name  MD HAMZA AHMAD 
Designation  PG scholar department of Moalejat  
Affiliation  Ajmal khan tibbya college Aligarh Muslim University Aligarh  
Address  Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college Aligarh Muslim University Aligarh Uttar Pradesh India

Aligarh
UTTAR PRADESH
202002
India 
Phone  9520364762  
Fax    
Email  hamzahmad0484@gmail.com  
 
Source of Monetary or Material Support  
Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college Aligarh Muslim University Aligarh 202002 
 
Primary Sponsor  
Name  Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college  
Address  Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college Aligarh Muslim University Aligarh Uttar Pradesh India 202002 
Type of Sponsor  Government medical college 
 
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 Md Hamza Ahmad   Ajmal khan tibbya college and hospital   Department of Moalejat Faculty of unani medicine Ajmal khan tibbya college Aligarh Muslim University Aligarh 202002
Aligarh
UTTAR PRADESH 		 9520364762

hamzahmad0484@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sufoof of unani formulation   Unani formulation will be given 5 gm BD in powder form orally after meal for 3 months 
Comparator Agent  Tablet Rosuvastatin  Tablet Rosuvastatin 10mg OD will be given orally at night for 3 months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in age group of 30-60 years
Patients of either gender
Patient willing to sign the written informed consent
Clinically stable patients of dyslipidemia with following subjective and
objective parameters
Subjective parameters:
Patient showing any one of the following symptoms will be asked to go for required
investigations & will be included in the study accordingly.
Increasing body weight
Dyspnoea on exertion
Fatigue
Xanthelasma
Corneal arcus
Joint pain
Patients having any two of the following will be included in the study:
Total Serum cholesterol ( 200-300 mg/dl)
Serum triglyceride (160-300 mg/dl)
LDL (130-190 mg/dl)
HDL (30-60 mg/dl)
LDL (30-50 mg/dl) 
 
ExclusionCriteria 
Details  Patient below 30 years and above 60 years
Any uncontrolled systemic illness
Any type of liver disease
Patient of CAD
Uncontrolled type 2 Diabetes Mellitus
Hyperthyroidism and Hypothyroidism
Pregnant and lactating women
Alcoholic
Patient who fails to give consent
In case of worsening of symptoms patient may be withdrawn from trial and
be shifted to standard treatment. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in objective parameters
Objective assessment (Serum Total Cholesterol, LDL, HDL, VLDL, Serum
Triglyceride)  		 90 days on monthly follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters
Subjective assessments Increasing body weight
Dyspnoea on exertion
Fatigue
Xanthelasma
Corneal arcus
Joint pain 		 90 days on fortnightly follow up  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   22/04/2024 
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 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   Disorders of lipoprotein metabolism are collectively referred to as “dyslipidaemia.”Dyslipidaemias are generally characterized clinically by increased plasma levels of cholesterol, triglycerides, or both, variably accompanied by reduced levels of HDL cholesterol. The majority of patients with dyslipidemia have some combination of genetic predisposition (often polygenic) and environmental contribution (lifestyle, medical condition or drug).Increased levels of LDL cholesterol, remnant lipoproteins as well as decreased levels of HDL cholesterol have all been associated with an increased risk of premature vascular disease. Statins are considered first-line treatment for patients with dyslipidemia. Therapeutic benefits include plaque stabilization, improvement of coronary endothelial function,
inhibition of platelet thrombus formation, and anti-inflammatory activity. Adverse effects includes hepatotoxicity (dose related) with increase in serum transaminaselevels, headache, sleep disturbances, Myopathy- muscle pain & weakness with raisedplasma creatinine kinase activity, gastrointestinal- anorexia, nausea vomiting &diarrhoea.More serious adverse events are rare, but include rhabdomyolysis, hepatitis and
angioedema.The management of Saman-e-Mufrit is strenuous exercise, avoidance of fatty diet, excess use of vinegar, dalak-e-sulb, Hammam and specific drugs those have property to
reduce the weight. Unani system of medicine possess a large number of single and compound drugs, which are being used in the treatment of Saman-e-Mufrit like Muqil, LukMaghsool, Marzanjosh etc. To provide effective and safe treatment through Unani Medicine in Dyslipidemia, present study has been designed to validate the efficacy and safety of “Unani Formulation”which has been described in the well known unani pharmacopeia Byaz-e-khas.
 
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