1 Formulation of Anti-diabetic Herbal Tea from Natural Holy Basil Leaves and its Glycemic Role for Type-2 Diabetic patients * A.K. Obidul Huq 1,2, Dr.K.M. Formuzul Haque 3 and Dr.H.N.M. Ekramul Mahmud 1 1. Department of Chemistry, University of Malaya, 50603, Kuala Lumpur, Malaysia. 2. Department of FTNS, Mawlana Bhashani Science and Technology University, Santosh, Tangail-1902, Bangladesh. 3. Department of NFE, Daffodil International University, Dhaka, Bangladesh. *

INTRODUCTION  Type-2 Diabetes mellitus is a major public health problem in Bangladesh. Every year around 0.2 million people are newly engaged in diabetes.  Normal plasma glucose level (fasting adult) is below 110mg/dl.  A major goal in controlling diabetes is to keep plasma glucose level as close to the desired range as possible. Traditionally, type-2 diabetes has been controlled with dietary modifications, exercise, oral hypoglycemic drugs etc.

Introduction Contd.  Holy basil is sacred as ‘Queen of Herbs’ in Indian subcontinent. It is considered to be an adaptogen and balancing different process in the body.  In Ayurvedic medicine it is believed as to promote longivity (Elixir of life)

Introduction Contd.  A blended herbal tea was formulated from holy basil leaves which was acted as anti-diabetic.  Each sachet (1g) of Anti-diabetic tea contains Natural holy basil (Ocimum sanctum), F-O blended powder (Collected from Tinospora crispa stem), ginger (Zingiber officinale) powder, and Stevia spp etc. in certain proportion.  This study was evaluated the efficacy of anti-diabetic tea as an adjunct in the treatment of type-2 diabetic patients in BIRDEM Hospital, Bangladesh, during a three-month trial period.

OBJECTIVES To observe the efficiency of the anti-diabetic herbal tea on the glycemic control of Type-2 diabetes mellitus in terms of estimate the-  Fasting and 2 hours Post Prandial Plasma glucose level  HbA 1 c and total glycated Hb level  TG and different cholesterol level and  other necessary blood parameters.

METHODOLOGY This study was carried out in two Phases First Phase: Formulation and standardization of Anti-diabetic tea. Organoleptic acceptability was evaluated by nine point Hedonic scale. Research Settings: Quality control research laboratory in Rigs Herbs, Dhaka, Bangladesh. Toxicity test done in BCSIR Laboratories, Chittagong. Second Phase: A randomized, single-blind Placebo-controlled clinical trial. Setting place: Renowned Diabetic Hospital in Bangladesh (BIRDEM, Dhaka). Subjects: A total number of Thirty (30) individual was completed the study period (15 from intervention group and 15 from control group).

Background information: Socio-economic status, age, sex, weight, height, BP etc. Inclusion criteria: Aged between years and no gender bias (both male and female) Patients diagnosed as type -2 diabetes with FPG>110 mg/dl Patients who have given written informed consent Exclusion criteria: All type-2 patients on insulin treatment High blood pressure (recognized) Obesity (BMI>30) Type-1diabetes Presence of debilitating illness Patients who take more than one drugs. Methodology Contd.

Intervention groups: All subjects in the treatment group were taken 2 sachets anti-diabetic tea each day up to 3 months. In addition they were take only single drug or not. Control groups: All subjects were taken 2 sachets Blank Tea (only black tea presence) each day in addition to they took only single or no drug. Ethical consideration: If any Type-2 diabetic patients who taken Blank Anti-diabetic Tea (Researcher know the patients) and not taken other hyperglycemic drugs, then when he/she falls very sick and very high rise of blood glucose level or any other complexities, then it can be treated with necessary drugs.

RESULTS Table 1: Organoleptic Acceptability of the Formulated Anti-diabetic Herbal tea Quality FactorsHedonic Scale (1-9) PointsResults Appearance7.81Like Moderate Color8.36Like very much Flavor7.54Like Moderate Texture and Granularity7.32Like Moderate Overall Acceptability7.90Acceptable

Variables Intervention Group n (%) Control Group n (%) Total n (%) Sex Male Female 8(53.3) 7 (46.7) 8(53.3) 7 (46.7) 16 (53.3) 14 (46.7) Age (Years) Weight (Kg) Height (cm) BMI Mean ± SD 47.9 ± ± ± ±2.9 Mean ± SD 48.7 ± ± ± ±3.3 Mean ± SD 48.2 ± ± ± ±3.1 Mean duration of diabetes (Y) 7.1 ± ± ±1.9 Table 2: Socio-demographic and background information of selected subjects at day Zero Results Contd.

Intervention Group n (%) Control Group n (%) Responses Before Intervention After Intervention Before Intervention After Intervention Polyurea13 (86.7) 1 (6.7) 13 (86.7)12 (80.0) Polyphagia11 (73.3) 2 (13.3) 12 (80.0)11 (73.3) Polydypsia12 (80.0) 2 (13.3) 12 (80.0)10 (66.7) Fatigue and lethargy 8 (53.3) 1 (6.7) 10 (66.7)9 (60.0) Table 3: Subject’s Health Condition and Complaints Results Contd.

Figure 1: Comparison of Fasting Plasma Glucose Level

Figure 2: Comparison of 2-h Post Prandial Plasma Glucose Level

Intervention Group Mean ± SD Control Group Mean ± SD Blood Parameters Before Intervention After Intervention Before Intervention After Intervention Total glycated Hb (%) 6.8± ± ± ±1.2 Hb A 1 c (%) 9.4± ± ±1.69.6±1.5 Table 4: Total glycated Hb and HbA 1 c level in before and after Trial Results Contd.

Table 5: Comparison of Lipid Profile Results Contd. Intervention Group Mean ± SD Control Group Mean ± SD Blood parameters Before Intervention After Intervention Before Intervention After Intervention LDL (mg/dl) 155±23 137±45 162±35167±56 HDL (mg/dl) 42±21 45±26 37±1739±23 Total Cholesterol (mg/dl) 217±45 198±38 223±52232±46 Triglycerides (mg/dl) 127±56 112±42 114±49118±51

Table 6: Comparison of Other Laboratory Tests Results Contd. Intervention Group Mean ± SD Control Group Mean ± SD Blood parameters Before Intervention After Intervention Before Intervention After Intervention ESR 25±1318±11 26±15 23±16 Hb (g/dl) 10.08± ± ± ±1.12 SGPT 31±1229±12 27±15 32±15

Toxicity Test Results Contd. The animal studies were found that no harmful or toxic ingredients founds in that blended mixture from the test report of Chittagong BCSIR laboratories, Bangladesh.

CONCLUSIONS  Herbal Blended Tea (as an adjunct therapy) is a potent anti-diabetic agent as revealed by its plasma glucose lowering effect, reduction in HbA 1 c and glycated hemoglobin.  It has an ability to reduce the cholesterol and triglycerides which are important risk factors for diabetes.  This suggests that the Anti-diabetic herbal blended tea is also safe for consumption.  However, this poses a challenge for further studies as introduced a confounding factor and need to know the mode of action how it can work against Diabetes?

ACKNOWLEDGEMENTS  Financial Support Ministry of Science and Information, Communication and Technology, GOB  Dr. Amina Khaleque Khan, Defuty Chief Medical Officer, BIRDEM, Bangladesh.  Rigs Herbs, Dhaka, Bangladesh.

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