{'fraction_non_alphanumeric': 0.024129208017123954, 'fraction_numerical': 0.013913212687293248, 'mean_word_length': 5.078651685393258, 'pattern_counts': {'":': 0, '<': 2, '<?xml version=': 0, '>': 2, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Therapeutic efficacy and safety of Unani formulation in patients of Fasaad-e-tashahhum-e-dam (dyslipidemia): a randomized open standard controlled clinical study

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. Dyslipidemia which includes either overproduction or deficiency of lipoproteins or both manifests an elevation of serum total cholesterol or triglyceride or both, or low density lipoprotein (LDL) and decrease in high density lipoprotein (HDL) concentration. Evidently, health care providers face a great deal of challenge to deal with dyslipidemia and its associated comorbidities, since it plays a significant role in development of coronary artery disease (CAD) and immensely contributed to the annual death rates globally. There is a 4 fold prevalence of coronary heart disease in Asia as compared with general USA population. The unattended dyslipidemia vulnerably invites certain catastrophic consequences like atherosclerosis, stroke and ischemic heart disease (IHD). The cause responsible for such lipid disorder could be primary, and more commonly secondary to diabetes mellitus, nephrotic syndrome and hypothyroidism. It is important for a patient with dyslipidemia to have a full clinical assessment and thereby timely appropriate treatment so that the life-threatening consequences of disease may be controlled or halted optimally. Despite ABSTRACT


INTRODUCTION
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. Dyslipidemia which includes either overproduction or deficiency of lipoproteins or both manifests an elevation of serum total cholesterol or triglyceride or both, or low density lipoprotein (LDL) and decrease in high density lipoprotein (HDL) concentration. 1,2 Evidently, health care providers face a great deal of challenge to deal with dyslipidemia and its associated comorbidities, since it plays a significant role in development of coronary artery disease (CAD) and immensely contributed to the annual death rates globally. 3 There is a 4 fold prevalence of coronary heart disease in Asia as compared with general USA population. The unattended dyslipidemia vulnerably invites certain catastrophic consequences like atherosclerosis, stroke and ischemic heart disease (IHD). 4 The cause responsible for such lipid disorder could be primary, and more commonly secondary to diabetes mellitus, nephrotic syndrome and hypothyroidism. 5,6 It is important for a patient with dyslipidemia to have a full clinical assessment and thereby timely appropriate treatment so that the life-threatening consequences of disease may be controlled or halted optimally. Despite remarkable advancement in dyslipidemia therapy, it continues to raise significant economic and personal burden as risk factor of cardiovascular disease. The management of dyslipidaemia is a two-way process; nonpharmacological and pharmacological. The nonpharmacological approach includes diet, food and additives and reduction of weight and exercises. The pharmacological approach consists of drug therapy to aim at maintaining lipids in recommended range. Currently available drug classes that affect lipoprotein metabolism are listed in Table 1.

Aim and objectives
The aim of the study was to determine to evaluate the therapeutic effect and safety of a newly formulated Unani drug in the patients with Fasaad-e-tashahhum-e-dam (dyslipidemia) and to compare it with the effect of rosavastatin by open randomized controlled clinical study.
The active investigation product was supplied to the patients in the powder form on each visit in small disposable poly packs from the day one. The investigational products were stored in dry and cold place and the patients of test group were also instructed for the same, the daily dosage of 4.5 g was advised orally for two months. The standard drug rosavastatin in the form of tablet with daily dosage of 10mg orally was administered to control group for two months.

Sample size calculation
Using GPOWER software (version 3.0.10), it was estimated that the least number of patients required in each group with 80% power, 0.91 effect size and 5% significance level is 20. Since we had to include two groups in our study, therefore a total of 40 samples was included in our study.

Statistical methods
The recorded data will be compiled and entered in a spreadsheet (Microsoft excel) and then exported to data editor of SPSS version 20.0 (SPSS Inc., Chicago, Illinois, USA). Categorical variables will be summarized as frequencies and percentages and continuous variables will be expressed as mean±SD.
Unpaired t-test for difference between two independent groups will be applied to analyze the recorded data and paired t-test will be employed to analyze the difference within groups.

Inclusion criteria
Patients with following criteria's were included ( To minimize the selection bias, participants fulfilling the inclusion criteria and willing to participate in the study were randomly divided into test and control group. Due to time constraint, lottery method was used for randomization. The study was carried out strictly according to guide lines of good clinical practices, embodying the principles mentioned in Declaration of Helsinki. Informed consent was obtained from all participants and approval from the Institutional Review Board was obtained.

RESULTS
The age distribution of patients of test group and control group is shown in    Table 5 shows family history among test and control group. In test and control group, majority of participants had family history of hyperlipidaemia (60%) and (75%) respectively. Only (40%) and (15%) had no family history of hyperlipidaemia in test and control group respectively.    whereas HDL was raised by 4.91%. The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance p=0.142. In Table 8, illustrates that in test group S. cholesterol was reduced by 20.73%, S. triglyceride was reduced by 21.59%, LDL was reduced by 18.02%, VLDL was reduced 33.75% which were all statistically significant at p<0.0001 whereas HDL was raised by 4.01%. The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance p=0.072. In Table 9, the comparison of test and control group with respect to cholesterol, triglyceride, HDL, LDL and VDL.
We observed from the table that both the treatments drastically improve the parameters but none of the treatment can be considered superior to other because statistically there is an insignificant difference (p value>0.05) between test and control group with respect to cholesterol, triglyceride, HDL, LDL and VDL.

DISCUSSION
In present study, we observed that the incidence of patients with dyslipidaemia were highest in the age group of 31-45 years constituting (52.5%) of total numbers of patients followed by (40%) patients in the age group of 46-50 years and (7.5%) were in the age group of 16-30 years. This is in concurrence with the increased incidence of dyslipidaemia in the middle age group. This data shows that more prevalence of dyslipidaemia found in age group of 31-45 years, second high incidence was found in age over 50 years. Our study is closely related with the study conducted by Sawami et al (2008) who reported that prevalence of dyslipidaemia is high in 31-40 years of patients. 12 It is also reported that prevalence over the age 60 years is also high suggested by Estari et al (2009). 13 In the sample taken for the study, 65% patients were male in comparison to 35% of female patients. This indicates the increased incidence of dyslipidaemia among male population but the conclusion cannot be drawn as the sample size is small. According to Sina et al, rest is always cooling and moistening in nature. It is cooling because of which there is no excitation of heat and there is an inward collection and aggregation of waste matter. In the present study, 60 of patients had a positive family history of dyslipidaemia, while 40% did not have any family history of same. This data shows that the incidence of positive family history (primary dyslipidaemia) is higher. Present data may be interpreted as incidence of primary dyslipidaemia is varying according to type of gene involved in mutation. We observed that majority of patients i.e.; 40% had balghami temperament in test group and 50% had balghami temperament in control group. It is mentioned that Baroodate Jigar produces more Khilte balgham. Ultimately temperament of organs becomes balghami (phlegmatic). It is suggested by Ibne Rushd in Kitabul Kulliyat. 17 We calculated mean and standard deviation of lipid profile (S. cholesterol, triglyceride, HDL, LDL, VDL) among both test and control group patients before and after the treatment and observed that lipid profile significantly improved within both test and control group after the treatment because the observed p value was <0.001* for all the lipid parameters; however, there was an insignificant difference with respect to lipid profile parameters between test and control group after the treatment because the observed p value was >0.05 for all the parameters which indicates that both the treatments are equally effective in improving the lipid profile. Statistically no side effect was observed in test group, compliance to the treatment was found good.

CONCLUSION
The overall effect of the Unani formulation was found quite encouraging in the treatment of dyslipidaemia.
Marked improvements were evident in objective parameters like cholesterol, triglyceride and LDL, VLD. Both test and control drugs have same effects on lipid profile parameters.
Statistically no side effect was observed in test group, compliance to the treatment was found good. These results conclude that the test drug is quite safe in the treatment of dyslipidaemia. Hence, we recommend practitioners to opt for proposed Unani formulated drug for optimal results.