Clinical effectiveness of Unani drugs in comparison to conventional drug in the treatment of dyslipidaemia (abnormal amount of fat in the blood)

Phase 2

Not yet recruiting

• Conditions: Disorder of lipoprotein metabolism, unspecified,

• Registration Number: CTRI/2019/05/019066
• Lead Sponsor: Central Research Institute of Unani Medicine

Brief Summary

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

Dyslipidemiais co-related with *Siman MufritÌ£*in Unani system ofmedicine in clinical features and complications. Prolonged dyslipidemia may lead to Atherosclerosis, Ischaemic Heart Disease,Hypertension, Stroke, Nephropathy, Retinopathy, Diabetes, Obesity, Fatty liver.[2]Ischemic HeartDisease (8.92 million deaths per year) is the main cause of death all over theworld Worldwide one-third of Ischemic heart disease is due todyslipidemia. In 2008 the global prevalence of raised total cholesterol levelamong 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 ofAtherosclerosis and these are the most modifiable risk factor for Coronaryartery disease. [5] According to the WHO World Health Statistics Report,globally one in six adults are obese and nearly 2.8 million individuals dieeach year due to overweight or obesity. [6] Dyslipidemia is one of the major factorconstituting to Metabolic syndrome which is defined by a constellation of aninterconnected physiological, biochemical, clinical, and metabolic factors thatdirectly increases the risk of atherosclerotic cardiovascular disease. [7,8] This includesAtherogenic dyslipidemia, glucose intolerance, hypertension, proinflammatorystate, and a prothrombotic state. Raised level of cholesterol increases therisk of heart disease and stroke.

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

Highprevalence of disease, life-threatening complications, and complications ofconventional medicine warrants search of treatment which should be safe,efficacious, cost-effective and easily available to alleviate such a complexdisease of serious complications. In Unani system of medicine, the drug whichhas 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]

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-31
• Last Update Posted: 2019-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical assessment of the change in Lipid and Lipoprotein level	At baseline, 2nd, 3rd and 4th followups

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine; 🇮🇳 Hyderabad, TELANGANA, India

Central Research Institute of Unani Medicine

🇮🇳Hyderabad, TELANGANA, India

Qurratul Ain

Principal investigator

8273508814

qurratulainjunaid@gmail.com