EVALUATING HYPOLIPIDEMIC POTENTIAL OF KASNI SEED (CICHORIUM INTYBUS) PREPARATIONS IN NEWLY DIAGNOSED PATIENTS OF METABOLIC DISORDER

EVALUATING HYPOLIPIDEMIC POTENTIAL OF KASNI SEED (CICHORIUM INTYBUS) PREPARATIONS IN NEWLY DIAGNOSED PATIENTS OF METABOLIC DISORDER

Praveen Katiyar ^{* 1, 2}, Amod Kumar ¹, Arvind K Mishra ³, Rakesh K. Dixit ¹ and Ajay K. Gupta ⁴

Department of Pharmacology & Therapeutics ¹, Department of Internal Medicine ³,  King George's Medical University, Lucknow, U.P., India

University Institute of Health Sciences ², University Institute of Pharmacy ⁴,  C.S.J.M. University, Kanpur, U.P., India

ABSTRACT: Objective: To evaluate hypolipidemic potential of Kasni (Cichorium intybus) seed preparations combined with oral hypoglycemic agent in treatment of patients of newly diagnosed type 2 DM. Methods: Newly diagnosed 90 patients of Type2DM, age 35-65years, of either sex were divided into 3 groups. Each group having 30 patients (19 male and 11 females) matched with each other in terms of age and sex. In group I only Glycomet SR once a day and in group II/III 6 grams crude seed powder or 50 ml decoction of crude seed powder twice a day in combination with Glycomet SR once in a day, was given for 90 days. Serum cholesterol, triglyceride, LDL and HDL levels were measured at zero, 30th, 60th and 90th day. Results: All the three groups showed a significant reduction in cholesterol, triglyceride and LDL across the four time periods. Post hoc Tukey HSD test shown that there was a significant difference between group I & II (p=0.045) and group I & III (p=0.000) for cholesterol; group I & II (p=0.008) and group I & III (p=0.000) for triglyceride and I & II (p=0.032) and group I & III (p=0.001) for LDL. While there was a significant increase found in HDL level.  Conclusions: The add on  therapy with Kasni seed preparations is more effective as hypolipidemic agent than only oral hypoglycaemic agent in decreasing serum cholesterol, triglyceride and LDL levels of selected patients. Among Kasni seed preparation treated groups, decoction was found better than crude seed powder.

Hypolipidemia, Diabetes,

Kasni, Cholesterol, Triglyceride,

LDL, HDL, Type2DM

INTRODUCTION: The metabolic disorders are main and increasing public-health and clinical challenge worldwide because of urbanization, excessive energy intake, increasing obesity, and sedentary life styles ¹. According to International Diabetes Federation (IFD) diabetes is one of the major metabolic disorders and a dangerous risk factor for heart problems. Twenty five percent of the world’s adults have metabolic disorders ². Recently in year 2013 the American Heart Association also reported that adults (age 20 or above) have abnormal serum lipid profile ³.

Persons with such conditions are twice as likely to die from, and thrice as likely to have a heart attack or stroke as compared with others. Type 2 diabetes mellitus is one of the most common chronic diseases in the whole world and the fourth or fifth leading cause of death in the developed countries; it accounts for 90 percent of all diabetes and has become one of the major causes of premature ill health and death - mainly through the increased risk of cardiovascular disease (CVD) which is responsible for up to 80 percent of these deaths. As per a projection, there will be about 23.3 million deaths by CVD worldwide by 2030 ⁴.

However, even before levels of blood glucose are high enough for a person to be diagnosed with diabetes, hyperglycaemia and related changes in blood lipids (hypertriglyceridemia, hypercholesterolemia and decrease in the ‘good’ cholesterol HDL-c increase a person’s risk of CVD ². Diabetes like metabolic disorder and hyperlipidemia has strong correlation with each other and are considered as a first order risk factor for atherothrombotic complications.

Worldwide, the first curative line of metabolic disorder was non-pharmacologic actions consisted of diet and lifestyle changes as well as appropriate care in order to decrease mortality and morbidity of such diseases. However, the major concern for medical scientists to find pharmacologic approach, and to increase the efficacy of chronic drug treatment. Medical researchers do have tendency to find curative agents among traditional sources ⁵. As per World Health Organization (WHO) about 70 percent population of entire world depends upon traditional and folk medicines. In India, about 80 percent of the rural population depends upon traditional and folk medicines for their health care ⁶. In this respect, many plant extracts have been assessed for their efficacy in metabolic disorders and hyperlipidemia; the Kasni (Cichorium intybus) is one of them, having a long history of therapeutic use in traditional medicine for many diseases specially diabetes ^{5, 7, 8}.

The genus Cichorium (Asteraceae) is made of six species with main distribution areas in Europe and Asia; Cichorium intybus L., commonly known as Chicory or Kasni is a medicinally important plant ^{9, 10}. Therefore, present study is one of initial attempt to investigate the beneficial effect of Kasni seeds in combination with oral hypoglycemic agents in treatment of patients with newly diagnosed metabolic disorder i.e. type 2 diabetes mellitus with regard to its hypolipidemic potential because IDF has also recommended to lower cholesterol and trigyceride, raise HDL and reduce LDL in diabetes.

MATERIAL AND METHODS:

In the present study, 90 patients of either sex, with newly diagnosed type 2 diabetes mellitus, age ranging between 35 to 65 years were included. All included patients were free from diabetic complications like CVD/ IHD, Neuropathy, Nephropathy and Retinopathy or any other disease. Pregnant and lactating women were not included in the study. The study was conducted in one of the most reputed medical institutions of India i.e. OPD of Medicine department, King George's Medical University, Lucknow, India during 1^st March 2013 to 30^th May, 2013. There were 19 males and 11 females in each group i.e. total 57 male and 33 female patients were selected for the present study. The study protocol was approved by Institutional Ethics Committee, King George’s Medical University, Lucknow, U.P., India (Ref.Code: 58 E.C.M. IIB/P21, letter no.: 2649/R.Cell 12 dated 20.10.2012). All participants were provided with specific written information about the aims of the study according to the Declaration of Helsinki, before their written consents were taken.

The selected participants were informed about all possible expected outcomes from the study. Written consent was taken from the study subjects. The included ninety (90) patients were divided into 3 groups. Each group having 30 patients (19 male and 11 females)(n=30) matched with each other in terms of age and sex.. The group - I patients on oral hypoglycemic agent were advised not to take any herbo-mineral preparation during the study duration, and this group served as standard. The patients of group – II were advised with Kasni crude seed powder (6 gms in the morning in fasting condition and 6 gms in the evening) in combination to oral hypoglycemic agent. The patients of group – III were advised with Kasni decoction (by instructing the patients to boil provided 6 grams crude seed powder in 100 ml water till 50 ml decoction remained) in combination to oral hypoglycemic agent.

The oral hypoglycemic agent prescribed was Glycomet SR containing Metformin Sustained Release once in a day in every group for 90 days. Preparations of Kasni seeds were given twice everyday upto 90 days in group II and III. A supervisor cautiously ensured that the selected patients were taking preparations of Kasni seeds appropriately. Blood samples were collected from all subjects before starting oral hypoglycemic agent/combination of crude Cichorium intybus seed powder and hypoglycemic agent/combination of Cichorium intybus crude seed powder decoction and oral hypoglycemic agent. Final sample was collected 12 hours after the last dose of 90^th day treatment with standard drug and in combination with preparations of Kasni seeds.

Plant material collection and Authentication:

Indigenous variety of Kasni seeds were obtained from International Institute of Herbal Medicine, Lucknow, through Organic India Pvt. Ltd. from organic certified fields. It carries WHO standard for identification of herbs. Some of these seeds were cultivated in the herbal garden of C.S.J.M. University, Kanpur and then grown plant was supplied to National Botanical Research Institute (NBRI) Lucknow, India, there it was identified as Cichorium intybus L. (Ref. No: NBRI/CIF/222/2011).

The seeds of Kasni were cleaned, desiccated and crushed to a powder with