AIMS:

To evaluate the clinical efficacy of Khadiradi   Ghanati and Chankraman in Madhumeha (Type 2 Diabetes).

OBJECTIVES:

To prove and compare the efficacy of Khadiradi Ghanvati and Chankramanin the management of Madhumeha (DiabetesType 2).

PLAN OF STUDY:

The study work will be divided into following parts 

1.   Conceptual study

2.  Pharmacognostical

3.  Pharmaceutical study

4. Clinical study

1. Conceptual study:

Various ayurvedictextbooks and previous research works related with the subject will be thoroughly screened, analyzed, summarized and referred for Madhumeha and diabetes and of the drugs under trial.

2. Pharmacognostical study:

Detailed pharmacognostical study will be done in the Pharmacognosy lab of IPGT & RA, Jamnagar where all the drugs of khadiradi ghanvati will be authenticated by appropriate methods.

3.Pharmaceutical study:

Pharmaceutical study of the finished product will be done in the Pharmaceutical Chemistry lab of I.P.G.T.& R.A, G.A.U, Jamnagar.

3. Clinical Study:

For the clinical trial approximately 40Patients complaining of ,Pipasa (Polydipsia),Kara-Pada Daha Supti, Nidradhikya, Alasya, Swed-aanga gandha, Asyamadhurya, Malam kaye, Netra-jihva-shravana-updeh, Vishra sharirgandha, Shithila Angata, Shita Priyatwam, Shwasa, Snigdha gatrata, Picchhila Patrata, Dantadinaam Maladhytwa, Gurugatrata, Nocturia, Polyphagia etc. fulfilling the criteria of inclusion and giving their consent to participate in the clinical trial will be selected irrespective of their sex, religion, occupation caste etc. from OPD and IPD of Kayachikitsa department of I.P.G.T. & R.A Hospital, Gujarat Ayurved University, Jamnagar. Patients on Oral Hypoglycemic Agents and anti- hypertensive drugs will be allowed to continue their conventional treatment.

DRUG REVIEW:

Table no 1 Ingredients of Khadiradi Ghanvati:

Table no. 2 Rasapanchakaof Ingredients of Khadiradi Ghanvati:

METHODS OF PREPARATION:

Khadiradi Ghanvati will be prepared under guidance of Pharmacy of I.P.G.T & R.A as per classical text reference.

STUDY DESIGN:

Study type: Interventional

 Intervention Model: Two Groups Assignment

 Allocation: Randomized

 Purpose: Treatment

Masking: Open

Timing: Prospective

End point: Efficacy and safety

Total 40 patients will be enrolled in study. The patients fulfilling inclusion criteria from OPD and IPD of IPGT & RA, Hospital, Jamnagar will be divided into two group on the basis of computer generated randomization method.

DIAGNOSTIC CRITERIA:

1. Presence of few features of Madhumeha like Avila Mutrata, Prabhut Mutrata(Polyuria), Kesheshu, jatilibhava, Keshnaka ativriddh, Pipilika abhisaranam etc. 

2. According to WHO (2006) recommendations for the diagnostic criteria for diabetes Fasting Blood Plasma glucose ≥7.0mmol/l (126mg/dl) OR Post Prandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl).

INCLUSION CRITERIA:

1.   Patients of both male and female sexes from age group 20-60 years.

2.   Signs and symptoms of Madhumeha.

3.   Fasting Blood Plasma glucose. ≥7.0mmol/l (126mg/dl)   OR Post Prandial Blood           Plasma Glucose ≥11.1mmol/l (200mg/dl).

4.   BMI ≥ 23 Kg/m² to 30 Kg/m²

5.  Diagnosed cases who are not practicing 6 km regular walk.

EXCLUSION CRITERIA:

1. Patients of Diabetes mellitus receiving Insulin. 

2. Patients having chronic complications of Diabetes mellitus.

3. MIcro vascular Retinopathy, Neuropathy and Nephropathy.

    4. Macro vascular Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.

      5. Other chronic debilitating disease like STD etc.

      6. Pregnant and lactating women.

      7. Tuberculosis and HIV.

      8. Patients with Prameha Pidika (carbuncle, furuncles, abscess)

INVESTIGATIONS:

Investigations will be carried out in both groups, before treatment and after completion of treatment for the purpose of assessing the effect of therapy, general condition of the patients and to exclude other pathology. 

1.  Routine haematological investigations like Hb%, ESRmm/hr

2.  Bio chemical examinations – Lipid profile, Fasting and Random blood Sugar, Serum Albumin, Albumin/Globulin ratio

3. Liver function test - SGOT, SGPT, Direct, Indirect & Total Bilirubin & Serum alkaline phosphatase, Prothrombin Time

4. Kidney function test (Urea, Creatinine & Uric acid)

5. HbA₁C Test.

6. Urine – Routine & Microscopic examination.

POSOLOGY:

Group A: Chankaraman 6 km with Placebo Capsule

Group B: Khadiradi Ghanvati

PATHYA-APATHYA:

Avoid withholding of urges, smoking, sedentary lifestyle, day sleep, consumption of curd, meat of Aanup Desh, food prepared with new cereals and lentils as well as flours, excess sweet and sour and salty substances. Restrict heavy, fried, and oily food. Anti kapha diet. Proper fasting, use of old rice and wheat, Yava, Patola, Lashuna, Shigru, Triphala, Guduchi leaves, Kapittha, Jambu, Haridra, bitter gourd and fenugreek.

CRITERIA OF WITHDRAWL:

The participants will be allowed to withdraw from the clinical trial if there is any major ailment. Subject not responding to treatment or developing any serious adverse drug reaction of therapy will be withdrawal from the study.

REPORTING OF ADR:

Adverse drug reactions if observed in the patients will be registered and duly reported to ADR Cell (Pharmacovigilance cell of GAU).

CONSENT PROCEDURE:

Written informed consent/Assent from patients will be taken prior to the initiation of clinical study in the recruited patients with suitable provisions for withdrawal.

FOLLOW UP:

Follow up study will be carried out for one month after completion of the treatment. Pathya- Apathya and Chankramana will be continued during the follow up period, Medicine (if required) will be given from OPD of Kayachikitsa IPGT & RA Hospital Jamnagar.

ASSESMENT CRIETERIA:

 Fasting Blood Plasma glucose.    ≥7.0 mmol/l (126mg/dl)   OR Post Prandial Blood Plasma glucose.  ≥11.1 mmol/l (200mg/dl)

 BMI ≥ 23 Kg/m²

1. Ati Pipasa/Trishnadhikya

2. Quantity of Urine

3.  Frequency of Urine

4. Kara-Pada Daha /Supti

 5. Nidradhikya

SUMMARY

The clinical study entitled as “Clinical study on Khadiradi Ghana Vati and Chankramana in the management of Madhumeha (Type 2 Diabetes)- An open Randomized Comparative Clinical Trial” was carried out with the following:

Ø  Aim and Objective

1.      To study the literature regarding the Type 2 Diabetes through modern medicine as well as Ayurvedic point of view.

2.      To evaluate the efficacy of Khadiradi Ghana Vati and Chankramana in management of Madhumeha (Type 2 Diabetes).

INTRODUCTION

This study was undertaken on account of increasing Type 2 Diabetes mellitus in the country as well as globally. This study is an attempt to decline the incidence of Madhumeha using very simple exercise i.e. Chankramana. India has been projected by WHO as the country with the fastest growing population of Diabetic patients. In India has remained at 11.8% in past four years, according to the National Diabetes and Diabetic Retinopathy Survey report released by the Health & Family Welfare Ministry. Mainly lack of exercise, lifestyle changes and unhealthy food habits caused such a hike in Madhumeha.

1.      CONCEPTUAL STUDY

The conceptual study included overall view of the disease and therapeutics from the Ayurvedic point of view as well as modern point of view. Historical review brings us the information about the disease since Vedic Kala and work done by previous research workers. The disease review comprises an elaborate coverage on Madhumeha in the field of Nidana, Poorvarupa, Rupa, Samprapti, Sadhyasadhyata, Chikitsa and Pathya-Pathya. The disease review from modern point of view included definition, classification, insulin bio-synthesis, secretion and action, etiopathogenesis, complications and treatment of type 2 diabetes mellitus. Efforts have been made on the basis of etiology, pathogenesis, signs and symptoms, complications and prognosis to correlate type 2 diabetes mellitus with Madhumeha.

2.      DRUG REVIEW

In the drug review, individual ingredients of Khadiradi Ghana Vati has been described in detail with latest possible research information along with its therapeutic properties. Khadiradi Ghana Vati contains Khadira, Puga and Kadara. Various aspects of Chankramana i.e indication, contraindications and benefits of it in Madhumeha disease are thoroughly reviewed from Samhitas and modern science.

3.      PHARMACOGNOSTICAL STUDY

Organoleptic characters of powdered Khadiradi Ghana Vati showed light pinkish brown coarse powder with astringent taste, slightly aromatic odour and hard and rough touch. Microscopic characters observed under microscope were cork cells, vessel elements, fibres and few stone cells of Kadara, cork cells, stone cells, rhomboid crystals and tannin contents of Khadira, Puga with trichome fragments that is simple and multicellular, parenchymal cells with brown content, fragments of vascular tissues with spirally and annularly thickened vessels.

4.      ANALYTICAL STUDY AND MICROBIOLOGY STUDY

The result of loss on drying was in Khadiradi Ghana Vati is 16.67 % w/w. The water-soluble extract as well as alcohol soluble extract values are 30.63 %w/w and alcohol soluble extract 26.96 %w/w. Total Ash value of Khadiradi Ghana Vati is 6.10 %w/w. pH value of Khadiradi Ghana Vati was 6 and tablet hardness is 3.83 kg/cm3. To authenticate drug quality during study microbiological study was done that revealed that Khadiradi Ghana Vati has stability and free from any microbial contamination.

5.      CLINICAL STUDY

40 patients fulfilling the inclusion and exclusion criteria were selected for the study, from the OPD and IPD of Kayachiktsa department of I.P.G.T. & R.A. Hospital, Jamnagar irrespective of their race, religion, caste & sex.

Diagnostic criteria for the study:

The diagnostic assessment criteria was done based on signs and symptoms of Madhumeha Prabhuta Mutrata, Avila Mutrata, Kshudadikya, Atipipasa, Pindikodweshtana and associated complaints such as Kara Pada Daha, Kara Pada Supti, Swedadikya, Malam Kayeshu, Netra Jihwa Shravana Upadeha, Visra Shariragandha, Snigdha Gatrata, Nidraadhikya, Shithila Angata, Guru Gatrata and Sheeta Priyatwa..

Objective crieteria:

1.      Fasting Blood Plasma glucose ≥7.0mmol/l (126mg/dl) or,

2.      Post Prandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl) or,

3.      HbA1C ≥6.5%.

Ø  Study type             -     Interventional

Ø  Study design          -    An open labelled randomized controlled clinical trial

Ø  End point-             -     Efficacy

Ø  Duration                -     8 Weeks

Ø  No. of groups        -       2

Ø  Sample size         -      Group A (Chankramana 6 km with placebo capsule): 20 patients

                              Group B (Khadiradi Ghana Vati): 20 patients

The effect was assessed on the basis of changes in subjective and objective parameters. Follow up study was carried out for one month after completion of the treatment.

6.      OBSERVATION

Maximum number of patients were afflicted to Guru Guna and Snigdha Guna (100%) along with faulty diet pattern like Vishamashana (80%) followed by Samashana (20%). 90% patients in the study had no exercise and only 10% had daily exercise. Maximum number of patients had Vatakaphaja Prakriti (80%). The maximum 16 patients (40%) had duration of diabetes for 0-2 years, followed by 32.5% had diabetes for 2-5years, 22.5% were having diabetes for 5-10 yrs. Only 5% had diabetes > 10 yrs. 47.5 % patients had family history of Diabetes mellitus and 52.5% patients had no family history of Diabetes.

Majority of the patients were taking food items which were having high glycemic index. These include Dadhi (97.5%), Mamsa (100%), Payaha (100%), GudaVikrita (100%), Shleshmajanaka Ahara (97.5%), Mutrajanaka Dravya (60%).

         14 patients each from Group A and Group B had FBS < 200 mg/dL. 70% patients fell under this category. 27.5% patients had FBS level 201-300 mg/dL. 6 patients from Group A and 6 from Group B. Only 2.5% patients had FBS > 300 mg/dL.

7.      Overall effect of therapy

At the end of study, all data were analyzed. From this, it was found that in group A 55% shows Marked Improvement followed by 40% having Moderate Improvement and 5% shows Mild Improvement. Chankaramana treatment is giving better result when used clinically. In Group B, Khadiradi Ghana Vati was given and 55% shows Marked Improvement followed by 35% having Moderate Improvement and 10% shows Mild Improvement.

Statistically both Chankaramana treatment and Khadiradi Ghana Vati treatment are insignificant i.e. both type of treatment has equal effect on the Madhumeha. Clinically Chankramana gave better results as compared to Khadiraadi Ghana Vati in terms of subjective parameters of Prabhutmutrata, Kshudadhikya. Atipipasa, Pindikodwestan, Kara pada Supti, Guru Gatrata, Nidraadhiky and. Snigdha/ Picchila Gatrata but statistically insignificant.

Clinically Khadiraadi Ghana Vati gave better results as compared to Chankraman in terms of objective parameters of diabetic profile in terms of approximately 5% although Chankramana also reduce FBS, PPBS and HbA1C to significant level.

Discussion

For breaking of the Samprapti of Madhumeha, treatment should work at the level of Dhatwagni and responding Kapha Dosha and Medodhatu. Most of the contents of drugs Khadiradi Ghana Vati was having Pramehahara property directly acting on etiopathogenesis of Madhumeha. By Khadira, Kadara, and Puga this Vati is having Tikta-Katu-Kashaya-Rasa, and their Laghu-Ruksha Guna, Ushna Virya, Katu Vipaka and Deepan-Paachan. This might have corrected Kapha Dushti and removes Medodhatwagnimandya which corrected Medo Dhatu Dushti. They also act on Dosha Vishesha i.e. BahudravyaSleshma,DushyaVishesha i.e. Kleda. The alleviation of Kapha- Pitta leads to removal of obstruction to path of Vata and Tridosha Shamaka drug also alleviates Vata Dushti, thus cause normal functioning of Doshas and Dhatus. Thus, Samprapti Vightana occurs and normal functioning of Doshas and Dhatus achieved which relieves the symptoms of Madhumeha.

Chankramana increases movement of Vayu in body. Chankramana decreases Medovruddhi by acting Medodhatwagni level, which in turn decreases Prameha and its related symptoms. Chankramana clears the channels (Srotasa) and increases the perceptive power of organs. According to modern science diet and exercise are the first come non- pharmacological action for treatment of diabetes mellitus. Chankramana of Shata Yojana act in the same way as exercise does to the body. Chankramana helps in lowering the glucose level in the blood. Chankramana also maintains the blood pressure, hence prevent body from complications of diabetes mellitus. Khadira is having antioxidant properties which act like free radical scavengers. They help in the regeneration of Beta cells of pancreas and thus help in deducing Prameha.

8.      Conclusion

The main Nidana of Prameha are lack of exercise and improper food habits. Excess food intake of Ushna, Snigdha and Guru are the primal cause of this disease. Chankramana is an easy remedy for Prameha.

Ayurveda Shamana Chikitsa for Prameha with Chankramana and Khadiradi Ghana Vati is very useful to treat mild to moderate persistent cases of diabetes mellitus which is very safe and cost-effective therapy. With long term use of the Chankramana and Khadiradi Ghana Vati, Nidana Parivarjana and with the modification in life style one can reduce the prevalence as well as morbidity due to diabetes mellitus and improve the quality of life in Patients.

SUMMARY

The clinical study entitled as “Clinical study on Khadiradi Ghana Vati and Chankramana in the management of Madhumeha (Type 2 Diabetes)- An open Randomized Comparative Clinical Trial” was carried out with the following:

Ø  Aim and Objective

1.      To study the literature regarding the Type 2 Diabetes through modern medicine as well as Ayurvedic point of view.

2.      To evaluate the efficacy of Khadiradi Ghana Vati and Chankramana in management of Madhumeha (Type 2 Diabetes).

INTRODUCTION

This study was undertaken on account of increasing Type 2 Diabetes mellitus in the country as well as globally. This study is an attempt to decline the incidence of Madhumeha using very simple exercise i.e. Chankramana. India has been projected by WHO as the country with the fastest growing population of Diabetic patients. In India has remained at 11.8% in past four years, according to the National Diabetes and Diabetic Retinopathy Survey report released by the Health & Family Welfare Ministry. Mainly lack of exercise, lifestyle changes and unhealthy food habits caused such a hike in Madhumeha.

1.      CONCEPTUAL STUDY

The conceptual study included overall view of the disease and therapeutics from the Ayurvedic point of view as well as modern point of view. Historical review brings us the information about the disease since Vedic Kala and work done by previous research workers. The disease review comprises an elaborate coverage on Madhumeha in the field of Nidana, Poorvarupa, Rupa, Samprapti, Sadhyasadhyata, Chikitsa and Pathya-Pathya. The disease review from modern point of view included definition, classification, insulin bio-synthesis, secretion and action, etiopathogenesis, complications and treatment of type 2 diabetes mellitus. Efforts have been made on the basis of etiology, pathogenesis, signs and symptoms, complications and prognosis to correlate type 2 diabetes mellitus with Madhumeha.

2.      DRUG REVIEW

In the drug review, individual ingredients of Khadiradi Ghana Vati has been described in detail with latest possible research information along with its therapeutic properties. Khadiradi Ghana Vati contains Khadira, Puga and Kadara. Various aspects of Chankramana i.e indication, contraindications and benefits of it in Madhumeha disease are thoroughly reviewed from Samhitas and modern science.

3.      PHARMACOGNOSTICAL STUDY

Organoleptic characters of powdered Khadiradi Ghana Vati showed light pinkish brown coarse powder with astringent taste, slightly aromatic odour and hard and rough touch. Microscopic characters observed under microscope were cork cells, vessel elements, fibres and few stone cells of Kadara, cork cells, stone cells, rhomboid crystals and tannin contents of Khadira, Puga with trichome fragments that is simple and multicellular, parenchymal cells with brown content, fragments of vascular tissues with spirally and annularly thickened vessels.

4.      ANALYTICAL STUDY AND MICROBIOLOGY STUDY

The result of loss on drying was in Khadiradi Ghana Vati is 16.67 % w/w. The water-soluble extract as well as alcohol soluble extract values are 30.63 %w/w and alcohol soluble extract 26.96 %w/w. Total Ash value of Khadiradi Ghana Vati is 6.10 %w/w. pH value of Khadiradi Ghana Vati was 6 and tablet hardness is 3.83 kg/cm3. To authenticate drug quality during study microbiological study was done that revealed that Khadiradi Ghana Vati has stability and free from any microbial contamination.

5.      CLINICAL STUDY

40 patients fulfilling the inclusion and exclusion criteria were selected for the study, from the OPD and IPD of Kayachiktsa department of I.P.G.T. & R.A. Hospital, Jamnagar irrespective of their race, religion, caste & sex.

Diagnostic criteria for the study:

The diagnostic assessment criteria was done based on signs and symptoms of Madhumeha Prabhuta Mutrata, Avila Mutrata, Kshudadikya, Atipipasa, Pindikodweshtana and associated complaints such as Kara Pada Daha, Kara Pada Supti, Swedadikya, Malam Kayeshu, Netra Jihwa Shravana Upadeha, Visra Shariragandha, Snigdha Gatrata, Nidraadhikya, Shithila Angata, Guru Gatrata and Sheeta Priyatwa..

Objective crieteria:

1.      Fasting Blood Plasma glucose ≥7.0mmol/l (126mg/dl) or,

2.      Post Prandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl) or,

3.      HbA1C ≥6.5%.

Ø  Study type             -     Interventional

Ø  Study design          -    An open labelled randomized controlled clinical trial

Ø  End point-             -     Efficacy

Ø  Duration                -     8 Weeks

Ø  No. of groups        -       2

Ø  Sample size         -      Group A (Chankramana 6 km with placebo capsule): 20 patients

                              Group B (Khadiradi Ghana Vati): 20 patients

The effect was assessed on the basis of changes in subjective and objective parameters. Follow up study was carried out for one month after completion of the treatment.

6.      OBSERVATION

Maximum number of patients were afflicted to Guru Guna and Snigdha Guna (100%) along with faulty diet pattern like Vishamashana (80%) followed by Samashana (20%). 90% patients in the study had no exercise and only 10% had daily exercise. Maximum number of patients had Vatakaphaja Prakriti (80%). The maximum 16 patients (40%) had duration of diabetes for 0-2 years, followed by 32.5% had diabetes for 2-5years, 22.5% were having diabetes for 5-10 yrs. Only 5% had diabetes > 10 yrs. 47.5 % patients had family history of Diabetes mellitus and 52.5% patients had no family history of Diabetes.

Majority of the patients were taking food items which were having high glycemic index. These include Dadhi (97.5%), Mamsa (100%), Payaha (100%), GudaVikrita (100%), Shleshmajanaka Ahara (97.5%), Mutrajanaka Dravya (60%).

         14 patients each from Group A and Group B had FBS < 200 mg/dL. 70% patients fell under this category. 27.5% patients had FBS level 201-300 mg/dL. 6 patients from Group A and 6 from Group B. Only 2.5% patients had FBS > 300 mg/dL.

7.      Overall effect of therapy

At the end of study, all data were analyzed. From this, it was found that in group A 55% shows Marked Improvement followed by 40% having Moderate Improvement and 5% shows Mild Improvement. Chankaramana treatment is giving better result when used clinically. In Group B, Khadiradi Ghana Vati was given and 55% shows Marked Improvement followed by 35% having Moderate Improvement and 10% shows Mild Improvement.

Statistically both Chankaramana treatment and Khadiradi Ghana Vati treatment are insignificant i.e. both type of treatment has equal effect on the Madhumeha. Clinically Chankramana gave better results as compared to Khadiraadi Ghana Vati in terms of subjective parameters of Prabhutmutrata, Kshudadhikya. Atipipasa, Pindikodwestan, Kara pada Supti, Guru Gatrata, Nidraadhiky and. Snigdha/ Picchila Gatrata but statistically insignificant.

Clinically Khadiraadi Ghana Vati gave better results as compared to Chankraman in terms of objective parameters of diabetic profile in terms of approximately 5% although Chankramana also reduce FBS, PPBS and HbA1C to significant level.

Discussion

For breaking of the Samprapti of Madhumeha, treatment should work at the level of Dhatwagni and responding Kapha Dosha and Medodhatu. Most of the contents of drugs Khadiradi Ghana Vati was having Pramehahara property directly acting on etiopathogenesis of Madhumeha. By Khadira, Kadara, and Puga this Vati is having Tikta-Katu-Kashaya-Rasa, and their Laghu-Ruksha Guna, Ushna Virya, Katu Vipaka and Deepan-Paachan. This might have corrected Kapha Dushti and removes Medodhatwagnimandya which corrected Medo Dhatu Dushti. They also act on Dosha Vishesha i.e. BahudravyaSleshma,DushyaVishesha i.e. Kleda. The alleviation of Kapha- Pitta leads to removal of obstruction to path of Vata and Tridosha Shamaka drug also alleviates Vata Dushti, thus cause normal functioning of Doshas and Dhatus. Thus, Samprapti Vightana occurs and normal functioning of Doshas and Dhatus achieved which relieves the symptoms of Madhumeha.

Chankramana increases movement of Vayu in body. Chankramana decreases Medovruddhi by acting Medodhatwagni level, which in turn decreases Prameha and its related symptoms. Chankramana clears the channels (Srotasa) and increases the perceptive power of organs. According to modern science diet and exercise are the first come non- pharmacological action for treatment of diabetes mellitus. Chankramana of Shata Yojana act in the same way as exercise does to the body. Chankramana helps in lowering the glucose level in the blood. Chankramana also maintains the blood pressure, hence prevent body from complications of diabetes mellitus. Khadira is having antioxidant properties which act like free radical scavengers. They help in the regeneration of Beta cells of pancreas and thus help in deducing Prameha.

8.      Conclusion

The main Nidana of Prameha are lack of exercise and improper food habits. Excess food intake of Ushna, Snigdha and Guru are the primal cause of this disease. Chankramana is an easy remedy for Prameha.

Ayurveda Shamana Chikitsa for Prameha with Chankramana and Khadiradi Ghana Vati is very useful to treat mild to moderate persistent cases of diabetes mellitus which is very safe and cost-effective therapy. With long term use of the Chankramana and Khadiradi Ghana Vati, Nidana Parivarjana and with the modification in life style one can reduce the prevalence as well as morbidity due to diabetes mellitus and improve the quality of life in Patients.