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DOI: https://dx.doi.org/10.18203/2349-3933.ijam20212772
Original Research Article
Regional Research Institute of Unani Medicine, Naseem Bagh University of Kashmir Srinagar J&K, Central Council for
Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi, India
*Correspondence:
Dr. Syed Sabahat,
E-mail: syedsabahatashraf924@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Hyperlipidemia which is interchangeably used with the term dyslipidemia essentially refers to the
condition of abnormality of lipid levels measured in the blood typically due to the disorder of lipoprotein metabolism.
The objective of this study was to determine the therapeutic effect and safety of newly formulated drug on patients with
Fasaad-e-Tashahhum-e-Dam (dyslipidemia) and compare it with the effect of Unani formulation and rosavastatin.
Methods: The present study was open randomized controlled clinical study. The study subjects were divided in two
groups, one group was given test drug (test group) and another group was given control drug (control group). All the
patients who qualified the inclusion criteria were randomly placed in either test or control group.
Results: In the present study we observed that both the groups were comparable with respect to age, sex lifestyle, family
history and mizaj. We found that both Unani formulated drug and standard drug rosavastatin significantly improves the
lipid parameters after the treatment with a p value of (<0.001*).
Conclusions: We concluded that the overall effect of the proposed Unani formulated drug was found quite fascinating
in the treatment of dyslipidemia. Apart from drug safety, visible improvements were evident in objective parameters
like cholesterol, triglyceride and LDL, VLD. However, the present study did not revealed that Unani drug is superior
to standard drug instead both the treatments are equally effective on the improvement of lipid profile parameters.
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Sabahat S et al. Int J Adv Med. 2021 Aug;8(8):1079-1085
remarkable advancement in dyslipidemia therapy, it additives and reduction of weight and exercises. The
continues to raise significant economic and personal pharmacological approach consists of drug therapy to aim
burden as risk factor of cardiovascular disease. The at maintaining lipids in recommended range. Currently
management of dyslipidaemia is a two-way process; non- available drug classes that affect lipoprotein metabolism
pharmacological and pharmacological. The non- are listed in Table 1.
pharmacological approach includes diet, food and
Table 1: Available drug classes that affects lipoproteins metabolism.7
Lipid/lipoprotein
Drug class Daily close Mechanisms Side effects Contraindications
in effects
HMGCoAre
Cholesterol Myopathy Absolute: active or
ductase in Lovastatin (20 80 mg), LDL-C 18-55%
synthesis, increased chronic liver
hibitors pravastatin (20-40 mg) HDL- C%-15%
hepatic liver enzymes disease relative
(statin)
Simvastatin (20-80 mg),
LDL receptor
fluvastatin (20-80 mg) <concomitant use
VLDL TG 7-30%
atorvastatin (10-80 mg), of certain drugs
production
cerivastatin (0.4-0.8 mg)
Elavated
Cholesterol Intestinal LDL 17% HDL,
tranaminases
absorption Ezetimible (10 mg) cholesterol TG-minimal Hypersensitivity
anngioedema
inhibitors absorption change
headache
Gastrointesti-
Absolute:
Cholestyramine (4-32 g), LDC-C 15-30 % nal distress,
Bile acid dysbetalipoproteine
Bile acid cholesterol (5-40 g), HDL-c n3-5% TG constipation,
excretion and mia TG>400 mg/dl
sequestrant colesevelam (3750-4375 no change or decreased
LDL receptors relative TG>200
mg) increase absorption of
mg/dl
other drugs
Flushing,
Immediate release Hyperglyce-
Absolute chronic
(crystalline) nicotinic mia,
liver disease severe
acid (1.5-3 g), extended LDL-C5-25% Hyperuricae-
Nicotinic VLDL hepatic gout, relative
release nicotinic HDL-C 15-35% mia (or gout),
acid synthesis diabetes,
(niaspan) (1- 2 g), TG 20-50% upper GI
hyperuricaemia,
sustained release distress,
peptic ulcer disease
nicotinoic acid (1-2 g) Hepatotoxici-
ty
Dyspepsia,
myalgia, LDL-C 5-20%
Gemfibrozil (600 mg gallstonezs, (may beincresed Absolute severe
Dyspepsia,
BID), fenofibratew (200 Gemfibrozi in patients with renal disease,
Fibric acid gallstones,
mg), clofibrate (1000 mg 1600 mg bid high TG) HDL-C severe hepatic
myopathy
bid) 600 mg 10-20% disease
bid elevated TG 20-50%
transminases
Presently, the treatment of dyslipidemia is lipid lowering management to prevent from adverse effect of
agents; these are statins (atorvastatin, simvastatin, conventional therapy. In conventional Unani system of
pravastatin and lovastatin, etc), bile-acid sequestrants medicine, there are large number of drugs; like Gugulipid
(cholestyramine and colestipol), resins, niacin, fibric acid (Camifora mukul), Alfalfa (Medicago sativa), Asian
analogs (fenofibrate, bezafibrate, and ciprofibrate) and ginseng (Panax ginseng), and Fenugreek (Trigonella
ezetimibe. Administration of these pharmacological agents foenum graecum), Garlic (Allium sativum) and onions
produces several adverse effects or side effects along with (Allium cepa), Turmeric (Crucuma longa), Lilly of the
antilipidemic activity like hepatotoxicity, myopathy, renal valley (Convallaria majalis), Black cumin (Nigella
dysfunction, dyspepsia, bloating, constipation, flushing, sativa), etc.11
pruritus of the face and upper trunk, skin rashes,
acanthuses nigricans, urticaria, hair loss, myalgias, fatigue, These drugs are Haar (hot) in mizaj (temperament) to
headache, impotence, and anaemia.8-10 Hence, there is modulate liver functions and also scientifically have been
pressing need for novel therapeutic agents for better reported to have lipid lowering effects, like Gugulipid
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Sabahat S et al. Int J Adv Med. 2021 Aug;8(8):1079-1085
The aim of the study was to determine to evaluate the Unpaired t-test for difference between two independent
therapeutic effect and safety of a newly formulated Unani groups will be applied to analyze the recorded data and
drug in the patients with Fasaad-e-tashahhum-e-dam paired t-test will be employed to analyze the difference
(dyslipidemia) and to compare it with the effect of within groups.
rosavastatin by open randomized controlled clinical study.
Inclusion criteria
METHODS Patients with following criteria’s were included (a) known
case of dyslipidemia with disease history of <3 years with
The Present study was conducted at postgraduate or without anti hyperlipidemia medication- total
department of Moalijat, Regional Research Institute of cholesterol ≥240 mg/dl, triglycerides <499 mg/dl (high),
Unani medicine (RRIUM), Srinagar, University of LDL ≥189 mg/dl, HDL >40 mg/dl in men and >50 in
Kashmir from 2018-2019. A newly established Unani woman, VLDL <0.930-1.006 g/l, ratio LDL to HDL <6.3
drug consists of several botanical ingredients- Zeera in man and 5 in woman; (b) patients of both sex; (c) age
(Carum cabrilinu, Tukhm Karafs (Apium graveolens between 20-50 years; and (d) patients who follow the
Linn), Marzenjosh (Oliganum vulgare Linn), Boora surkh protocol.
(Armenianbole), Tukhm Suddab (Rutagraveolanslinn) and
Exclusion criteria
Nankhaw (Trachyspe rmumammi Linn). These ingredients
were first dried at 40°C and then grounded to powder and Patients with following criteria’s were excluded- (a)
thereafter were taken in different quantity, mixed together known case of dyslipidemia with disease history of >3
properly and then packed. years total cholesterol <240 mg/dl, triglycerides >499
mg/dl (high), LDL <189 mg/dl, HDL <40 mg/dl in men
The active investigation product was supplied to the and <50 in woman, VLDL>0.930-1.006 g/l, ratio LDL to
patients in the powder form on each visit in small HDL >6.3 in man and >5 in woman; (b) known cases on
disposable poly packs from the day one. The use of corticosteroids and contraceptives; (c) history of
investigational products were stored in dry and cold place cardiovascular, renal, liver disease, AIDS and TB; (d)
and the patients of test group were also instructed for the history of alcoholism; (e) pregnant and lactating mothers;
same, the daily dosage of 4.5 g was advised orally for two and (f) age <20 and >50 years of age.
months. The standard drug rosavastatin in the form of
To minimize the selection bias, participants fulfilling the
tablet with daily dosage of 10mg orally was administered
inclusion criteria and willing to participate in the study
to control group for two months.
were randomly divided into test and control group. Due to
time constraint, lottery method was used for
Sample size calculation
randomization. The study was carried out strictly
according to guide lines of good clinical practices,
Using GPOWER software (version 3.0.10), it was embodying the principles mentioned in Declaration of
estimated that the least number of patients required in each Helsinki. Informed consent was obtained from all
group with 80% power, 0.91 effect size and 5%
participants and approval from the Institutional Review
significance level is 20. Since we had to include two
Board was obtained.
groups in our study, therefore a total of 40 samples was
included in our study.
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Sabahat S et al. Int J Adv Med. 2021 Aug;8(8):1079-1085
Table 3 displays sex wise distribution of patients among Table 5 shows family history among test and control
test group and control group. The above table indicated group. In test and control group, majority of participants
that in test group 55% were male and 45% were female had family history of hyperlipidaemia (60%) and (75%)
while in control group 65% were male and 35% were respectively. Only (40%) and (15%) had no family history
female. of hyperlipidaemia in test and control group respectively.
Family history of Test group Percentage within Control group Percentage within
hyperlipidemia (N=20) group (%) (N=20) group (%)
Present 12 60 15 75
Absent 8 40 5 15
Total 40 100 30 100
It is evident from above Table 6, that majority of patients Table 7, illustrates that in test group S. cholesterol was
i.e.; 40% patients among test group while in control group reduced by 16.9%, S. triglyceride was reduced by 14.66%,
(50%) had balghami temperament. In the present study, 40 LDL was reduced by 15.53%, VLDL was reduced by
patients of hyperlipidaemia were registered and were 22.12% which were all statistically significant at p<0.0001
randomly placed under test and control group. 20 patients whereas HDL was raised by 4.91%. The change that
were treated in test group with Unani formulation and 20 occurred with the treatment is not great enough to exclude
patients in control group were treated with rosavastatin. the possibility that the difference is due to chance p=0.142.
The effect of these treatment on the subjective and In Table 8, illustrates that in test group S. cholesterol was
objective parameters are presented. In reduced by 20.73%, S. triglyceride was reduced by
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Sabahat S et al. Int J Adv Med. 2021 Aug;8(8):1079-1085
21.59%, LDL was reduced by 18.02%, VLDL was reduced We observed from the table that both the treatments
33.75% which were all statistically significant at p<0.0001 drastically improve the parameters but none of the
whereas HDL was raised by 4.01%. The change that treatment can be considered superior to other because
occurred with the treatment is not great enough to exclude statistically there is an insignificant difference (p
the possibility that the difference is due to chance p=0.072. value>0.05) between test and control group with respect to
In Table 9, the comparison of test and control group with cholesterol, triglyceride, HDL, LDL and VDL.
respect to cholesterol, triglyceride, HDL, LDL and VDL.
Table 6: Distribution based on mizaj (N=40).
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Sabahat S et al. Int J Adv Med. 2021 Aug;8(8):1079-1085
patients.12 It is also reported that prevalence over the age Marked improvements were evident in objective
60 years is also high suggested by Estari et al (2009).13 In parameters like cholesterol, triglyceride and LDL, VLD.
the sample taken for the study, 65% patients were male in Both test and control drugs have same effects on lipid
comparison to 35% of female patients. This indicates the profile parameters.
increased incidence of dyslipidaemia among male
population but the conclusion cannot be drawn as the Statistically no side effect was observed in test group,
sample size is small. Present data correlates with the compliance to the treatment was found good. These results
observation of Goff et al, Sawami et al (2008), Estari et al conclude that the test drug is quite safe in the treatment of
(2009) and IC Health New Delhi Data base (2004).12-14. dyslipidaemia. Hence, we recommend practitioners to opt
Majority of the patients (60%) belonged to upper class for proposed Unani formulated drug for optimal results.
followed by (20%) in middle class and (20%) in lower
class in test group. Funding: No funding sources
Conflict of interest: None declared
Majority (50%) were in upper class followed by (25%) in Ethical approval: The study was approved by the
middle class and (25%) in lower class in control group. Institutional Ethics Committee
This is in concurrence that dyslipidaemia is ubiquitous
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