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 Farṭ-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
|
|
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
|
|
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) |
Jawārish 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 Mufriṭ 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 Taḥlīl (resolvent), Tajfīf (Desiccant), Tehzīl (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 Jawārish
Falafili having an indication for Siman Mufriṭ has
been selected for this study. [13,14,15] The drug constituting this
formulation having the hot and dry temperament and possesses Mulaṭṭif (Demulcent), Mufattiḥ (Deobstruent), Moḥallil (Resolvent), Qat-e-balgham, Haẓim (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 Jawārish 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 Jawārish
falafili in Dyslipidemia.
|