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CTRI Number  CTRI/2019/05/019066 [Registered on: 13/05/2019] Trial Registered Prospectively
Last Modified On: 10/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical effectiveness of Unani drugs in comparison to conventional drug in the treatment of dyslipidaemia (abnormal amount of fat in the blood) 
Scientific Title of Study   A Randomized, Standard Controlled, Clinical Study to Evaluate the Safety and Efficacy of Jawᾱrish Falafili in the Treatment of FartÌ£-e- Tadassum fi’l Dam (Dyslipidaemia) 
Trial Acronym  PGDL 
Secondary IDs if Any  
Secondary ID  Identifier 
FTD/D/JF-A/RCT/CCRUM/17-18 Version: 01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Qurratul Ain 
Designation  PG Scholar 
Affiliation  Central Research Institute of Unani Medicine 
Address  CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8273508814  
Fax    
Email  qurratulainjunaid@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohammad Nawab 
Designation  Reader 
Affiliation  Central Research Institute of Unani Medicine 
Address  CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Qamar Uddin 
Designation  Professor & HoD Moalajat 
Affiliation  Central Research Institute of Unani Medicine 
Address  CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine 
Address  Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 
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 
Qurratul Ain  Central Research Institute of Unani Medicine  Moalajat OPD No. 1, Dept. of Moalajat, New OPD Block, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda
Hyderabad
TELANGANA 
8273508814

qurratulainjunaid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, CRIUM, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Study Group (Unani Drug group)  JawaÌ„rish falafili: Method of Preparation- The drug will be prepared in single batch on the guidelines and method of preparation described in the National Formulary of Unani Medicine Part-1 in GMP certified pharmacy of CRIUM, Hyderabad. Dose & Route of Administration: Patients will be advised to take 10gms at night after meals Duration of therapy: 12 weeks  
Comparator Agent  Group B: Active Control Group (HMG-CoA Reductase inhibitors)  Tablet Atorvastatin. Dose: 20 mg/day at night with water Duration of therapy: 12 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants of any sex aged 30-60 years.
Participants with having following lipid or lipoprotein abnormality
in blood-
- Serum Cholesterol equal to or more than 200mg/dl.
- HDL-C less than 40 mg/dl
- LDL Cholesterol equal to or more than 130 mg/dl.
- Serum Triglycerides level equal to or more than
150mg/dl.
Both obese and non-obese. 
 
ExclusionCriteria 
Details  Participants aged less than 30 and more than 60 years.
Participants having a co-morbid condition like IHD, HT, Diabetes, etc.
Participants having a major systemic disorder which interferes in the
present study.
Pregnant or Lactating Women.
Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
Known cases of Immunocompromised states (HIV/ AIDS,
etc.)/Malignancies
Participant not willing to attend treatment schedule regularly 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Biochemical assessment of the change in Lipid and Lipoprotein level  At baseline, 2nd, 3rd and 4th followups 
 
Secondary Outcome  
Outcome  TimePoints 
Hemogram LFT, RFT, FPG, ECG and Urine R/M examination  At baseline, 3rd followup and after treatment, except ECG that will be at baseline and after treatment 
 
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   Phase 2 
Date of First Enrollment (India)   31/05/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dyslipidemia, synonymous with Hyperlipidemia or Hyperlipoproteinemia, defined as a disorder of lipoprotein metabolism, including lipoprotein overproduction or deficiency and manifested by elevation of the total cholesterol, the low-density lipoprotein (LDL) and the triglyceride concentrations, and a decrease in high-density lipoprotein (HDL) concentration in the blood. [1]

Dyslipidemia is co-related with Siman MufritÌ£ in Unani system of medicine in clinical features and complications.
Prolonged dyslipidemia may lead to Atherosclerosis, Ischaemic Heart Disease, Hypertension, Stroke, Nephropathy, Retinopathy, Diabetes, Obesity, Fatty liver.
[2]Ischemic Heart Disease (8.92 million deaths per year) is the main cause of death all over the world Worldwide one-third of Ischemic heart disease is due to dyslipidemia. In 2008 the global prevalence of raised total cholesterol level among adults (>5.0 mmol/l) was 39% (37%for males and 40% for females). [4]

Increase level of atherogenic lipoprotein especially LDL, IDL, lipoprotein(a) and chylomicron remnants contribute to the pathogenesis of Atherosclerosis and these are the most modifiable risk factor for Coronary artery disease. [5] According to the WHO World Health Statistics Report, globally one in six adults are obese and nearly 2.8 million individuals die each year due to overweight or obesity. [6] Dyslipidemia is one of the major factor constituting to Metabolic syndrome which is defined by a constellation of an interconnected physiological, biochemical, clinical, and metabolic factors that directly increases the risk of atherosclerotic cardiovascular disease. [7,8] This includes Atherogenic dyslipidemia, glucose intolerance, hypertension, proinflammatory state, and a prothrombotic state. Raised level of cholesterol increases the risk of heart disease and stroke.

Dietary management along with hypolipidemic drugs is the mainstay of treatment in conventional system of medicine, which include HMG-CoA reductase inhibitors (Statins- Atorvastatin, Simvastatin), Bile acid sequestrants (Resins- Cholestyramine, Colestipol), Lipoprotein lipase activators (PPARα activators, Fibrates- Clofibrate, Gemfibrozil), Lipolysis and triglyceride synthesis inhibitor (Nicotinic acid), Highly polyunsaturated long chain-3 Fatty acids but all of these have some side effects including constipation, exacerbation of hemorrhoids, nausea, increased bleeding related to vitamin-K malabsorption, Vitamin-A and D deficiencies. [9] Adverse effects associated with Statins are Cognitive loss, Neuropathy, Rhabdomyolysis, myositis, myalgia, pancreatic and hepatic dysfunction, increased the incidence of diabetes, sexual dysfunction. [10]

High prevalence of disease, life-threatening complications, and complications of conventional medicine warrants search of treatment which should be safe, efficacious, cost-effective and easily available to alleviate such a complex disease of serious complications. In Unani system of medicine, the drug which has Hot and Dry temperament and contains the property of TahÌ£liÌ„l (resolvent), TajfiÌ„f (Desiccant), TehziÌ„l (Emaciating), Mudirr (Diuretic) properties used in the treatment of obesity. [11,12,13]

Keeping in mind all of the above points and drawbacks of modern medicine, there is a need to search an effective medicine to treat dyslipidemia. After a review of the literature, a pharmacopoeial compound formulation JawaÌ„rish Falafili having an indication for Siman MufritÌ£ has been selected for this study. [13,14,15] The drug constituting this formulation having the hot and dry temperament and possesses MulatÌ£tÌ£if (Demulcent), MufattihÌ£ (Deobstruent), MohÌ£allil (Resolvent), Qat-e-balghamHazÌ£im (digestive), Mudirr-e-boul (Diuretic) properties. Some of the drugs in this formulation have been evaluated as an anti-hyperlipidemic effect. [16,17,18] A Preclinical study has already been conducted on JawaÌ„rish falafili as Anti- hyperlipidemic by Nazia et al. which shows significant results. So, the present study is designed to evaluate the efficacy and safety of JawaÌ„rish falafili in Dyslipidemia. 

 

 
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