A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of Unani Formulation in the management of Khalal shahmiyyat al-dam (Dyslipidaemia)

Dyslipidemia is a prevalent disorder characterized by abnormal levels of lipoproteins in the blood, leading to elevated serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides, while reducing high-density lipoprotein cholesterol (HDL-C) levels. It can be categorized into primary (genetic) and secondary (acquired) dyslipidemia, with the latter often resulting from lifestyle factors, co-morbid conditions, or medication use.

Recent epidemiological data suggest that over 50% of the adult population globally suffers from dyslipidemia, with a significant burden observed in both urban and rural populations in India . This condition significantly contributes to the development of atherosclerosis and cardiovascular diseases (CVD), which are leading causes of morbidity and mortality worldwide. According to the World Health Organization (WHO), cardiovascular diseases account for approximately 17.9 million deaths annually, emphasizing the urgent need for effective management strategies.

Untreated dyslipidaemia may leads to atherosclerotic cardiovascular diseases (ASCVD) mainly Ischemic Heart Diseases, cerebrovascular diseases, peripheral

arterial diseases, diabetes mellitus, hypertension, acute pancreatitis mainly due to triglycerides rich lipoprotein without increase in LDL-C.

Statins are the primary treatment for high LDL cholesterol, inhibiting its synthesis and enhancing LDL removal. Alternatives include bile acid sequestrants, cholesterol absorption inhibitors, fibrates, and niacin but all of these have some side effects including constipation, exacerbation of haemorrhoids, nausea, increased bleeding related to Vitamin-K malabsorption, Vitamin-A and Vitamin-D deficiencies.

The high prevalence of disease along with life-threatening complications at a cost of serious side effects associated with conventional medicine demands the search for a treatment that is safe, effective, economical, and easily accessible to alleviate such a complex disease with serious complications.In Unani System of Medicine, dyslipidemia is analogous to siman mufrit, attributed to an excess of dusumat (lipids) in the blood  and it is termed as Khalal Shahmiyyat al-Dam. Siman Mufrit is a disorder stemming from hazm-e-kabidi dysfunction and a predominance of cold temperament. Coldness causes  arteriosclerosis  (salabat), deposition  of  fat in  the  vessels leading  to  atherosclerosis  (tasaddud)  while  its  accumulation  in  body parts leads to obesity(Siman Mufrit).

In Unani System Of Medicine, there are various treatment modalities available for the management of Lifestyle disorder such as  dyslipidaemia:ilaj bil tadbeer (regimental therapy), ilaj bil ghiza (dietotherapy), and ilaj bil dawa*(pharmacotherapy)*. In ‘ilaj bil dawa’, basic principle is ‘Ilaj bil- zid. The drugs which have hot and dry temperament and possessing Mulattif, Mujaffif, Mudir, Muhallil, Mufatteh, Muhazzil pharmacological properties are used in the treatment of siman mufrit.

After a thorough review of literature, a classical Unani formulationmentioned in unani literature GHINA MINA having indication for Siman-i-Mufrit has been selected for the present study. The selected Unani formulation includes ingredients such as Ajwain, Badyan, Zeera, Bora armani, Donamarwa/Marzanjosh, and Luk Maghsool, which have demonstrated lipid-lowering effects in previous pre-clinical studies. This clinical study is designed to systematically assess the efficacy and safety of this formulation in the management of dyslipidemia.