1. 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. *Email: Obidulhuq@gmail.comObidulhuq@gmail.com

2. 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.

3. 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)

4. 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.

5. 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.

6. 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).

7. Background information: Socio-economic status, age, sex, weight, height, BP etc. Inclusion criteria: Aged between 45-50 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.

8. 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.

9. 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

10. 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 ± 2.8 64.7 ± 4.5 163.6 ± 7.5 24.1 ±2.9 Mean ± SD 48.7 ± 3.2 66.5 ± 5.4 164.5 ±8.1 24.5 ±3.3 Mean ± SD 48.2 ± 3.1 65.6 ± 4.9 164.1 ± 7.8 24.3 ±3.1 Mean duration of diabetes (Y) 7.1 ±1.87.4 ±2.27.3 ±1.9 Table 2: Socio-demographic and background information of selected subjects at day Zero Results Contd.

11. 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.

12. Figure 1: Comparison of Fasting Plasma Glucose Level

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

14. 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 5.5±1.1 6.3±1.158.4±1.2 Hb A 1 c (%) 9.4±1.4 8.5±1.4 9.2±1.69.6±1.5 Table 4: Total glycated Hb and HbA 1 c level in before and after Trial Results Contd.

15. 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

16. 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±1.210.22±1.2 10.5±1.02 10.51±1.12 SGPT 31±1229±12 27±15 32±15

17. 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.

18. 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?

19. 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.

20. Thank you