“Clinical Study in the Management of Type II Diabetes Mellitus (Madhumeha) by Haridradi Gana.”

Dr. Sandesh P. Goje

PG Scholar

MS AYURVEDIC MEDICAL COLLEGE, HOSPITAL

& REASERCH CENTER, GONDIA

9765934704

 

Background :Type II DM is one of the crucial risk factor in development of hyperlipidemia, atherosclerosis, Cardiovascular diseases, Renal diseases etc. and   leading cause of mortality.

Hypothesis : Haridradi Gana is most effective drugs in the management of Type II DM.

Aims & Objectives : To evaluate the efficacy of Haridradi Gana in the management of Type II DM .

Material & Methods : Newly diagnosed patients of Type II DM were selected and divided in 2 groups.

Group A- Haridradi Gana kwath given to 30 patients in a dose of 40 ml twice a day before meals for 60 days.

Group B- Allopathic Oral AntiHyperglycaemic drugs had given to 30 patients for 60 days.

Assessment was done on 0, 15, 30, 45 & 60th day.

Results:  Study shows significant results of Haridradi Gana in the Patients of Type II DM.

Conclusion : Group B patients also shows satisfactory results but some side effects; flushing, excessive sweating, drug dependency and habit forming tendency  are noticeable. Hence Haridradi Gana shows significant results in decreasing the blood glucose more effectively without any adverse effect so it can be used in the management of Type II DM.

Key words: Haridradi gana, Madhumeha, Type II DM, Dislipidemia. 

INTRODUCTION

In today’s Era it is found that everyone is running behind his life’s goal and achievement completely ignoring and not thinking about one’s own health. Sedentary life style, psychological stress, wrong dietary habits, not following proper daily and Seasonal regime are among the most common  contributory factors for contracting many life style diseases like diabetes mellitus, hypertension, CHD, Osteoarthritis, Infertility etc. The morbidity and mortality are high in diabetics as compared to other diseases. Dyslipidemia being major factor in Type II DM results in atherosclerosis. Decreased level of insulin as well insulin resistance is main problem, which results in increased plasma glucose level  which gives rise to clinical conditions such as polyuria, polyphagia, polydypsia, in addition with weight loss or weight gain, fatigue, recurrent UTI and Blurred vision.

Epidemiology: The prevalence of diabetes is swiftly increasing over the globe at an alarming rate. According to the International Federation of Diabetes, 415 million adults around the world are suffering from diabetes, and it is estimated that the numbers will reach around 642 million by 2040. The first World Health Organization (WHO) global report on diabetes demonstrates that the number of adults living with diabetes has almost quadrupled since 1980 to 422 million Diabetes has become one of the leading causes of premature deaths in most countries, mainly through the increased risk of cardiovascular disease which is responsible for over 50% of deaths in persons with diabetes. Although diabetes is sometimes considered the major concern for developed nations, the loss of life from premature death among persons with diabetes is greatest in developing countries. Nearly 80% of the total adult diabetics are in low or middle income countries. India leads the World and stands at the second position after China with 69 million people affected by diabetes and poses a daunting challenge to the sustainable development of the nation. Every tenth adult (9.3%) in India is estimated to be affected by diabetes. The WHO estimated every 26 per 100,000 persons die due to diabetes in India though it declined marginally and for males increased between 2000 and 2012.

The primary driver of the epidemic of diabetes is the rapid epidemiological transition associated with changes in dietary patterns and decreased physical activity as evident from the higher prevalence of diabetes in the urban population. This rapid increase is mostly attributed to lifestyle transitions resulting in obesity and physical inactivity, population aging, and urbanization. A study shows that a low-fiber diet with a high glycemic index was positively associated with a higher risk of type 2 diabetes mellitus (DM). Early feeding may also play a subsequent role in the development of type 2 diabetes in later life. Various studies found a strong association between prevalence of diabetes and overweight and obesity. Genetic factors partly determine the risk of type 2 diabetes. A study in India indicates that more than 50% of people with diabetes have poor glycemic control, uncontrolled hypertension, and dyslipidemia and a large percentage have diabetic vascular complications. Another study on Indian data shows that the common risk factors such as greater duration of diabetes, hypertension, poor metabolic control, smoking, obesity, and dyslipidemia are more prone to develop diabetic complications.

Need of Study:

In this Era of machine and modernization, Ayurveda is found to be blessing to the human beings. The present day society expects peak physical and mental performance from each of its member and an obese person is unable to find himself physically and mentally fit for it.  Being a symptomatic approach and limited relief with troublesome side effects to those suffering from Type II D.M, modern medical science & its management have enough scope to work out on its aetiopathological and management aspect of the Type II D.M.  So mankind hopes to search the perfect cure from Ayurveda through its holistic approach. In Ayurveda, Type II DM is described very earlier  in various Bruhattrayee as well as Laghutrayee, Sangraha granthas, Nighantu, etc.

Also the basic and fundamental ethics of ayurveda is “Nidan parivarjan & Samprapti vighatan chikitsa” keeping this in mind, the present study was planned. With this to be a social and noble aspect towards society it’s our kind responsibility to give cost effective, safe, easily available Ayurvedic remedy for Type II DM  Many research works has been conducted to get relief from Type II DM.so this work is a kind effort to elicit and  validate the efficacy of Haridradi gana in the management of Type II Diabetes Mellitus (Prameha). Above said Drugs are already mentioned by our Acharyas in Ashtang Hridaya Sanshodhanadi Ganasangraha Addhay no. 15/35-36.

 

| | वचाजलददेवाहनागरतीविषामय : |

हरिद्राव्दययष्टयाहृकलशीकुटजोव्दवा:  | |

 वचाहरिद्रादिगनावामातीसारणाशनौ|

मेद: कफाढयपवनस्तन्यदोषनिबहर्षनों | |

 | |A. ™.15/35,36.

 

So this study is an attempt to find a better solution in Ayurveda for the treatment of Type II Diabetes Mellitus (Madhumeha).

 

AIMS:

To study the efficacy of Haridradi gana in the management of Type II Diabetes Mellitus (Madhumeha).

 

OBJECTIVES:

1) To study of literature on Type II Diabetes Mellitus (Madhumeha) as  per Ayurveda  and  modern aspects.

2) To establish a correlation between Type II Diabetes Mellitus and (Madhumeha).

3) To study & access the following involvement in the pathogenesis of Madhumeha:- a) Dosha  b) Dushya  c) Strotas  d) Samprapti.

4)  To study the pharmacological action of the drugs of Haridradi gana.

5) Being a better availability, easily acceptable, cost effective and impressive treatment therapy; supports to our Health department.

 

 

MATERIALS AND METHODS:

Study design: – An Open Randomized Control Clinical trial.

MATERIALS:-

  1. Study of Meda, Medovriddhi, Medoroga, Atisthaulya and Obesity according to Ayurvedic and modern Literatures and concepts had perfomed.
  2. Study of literature on the drug ‘Haridradi gana’ and Morden Antihyperglycemic Drugs and its contents had done.
  3. Selection of patients from O.P.D. and I.P.D. in department of Kayachikitsa of M. S. Ayurvedic medical college, Hospital & Research Institute, Gondia, Maharashtra had been selected for the study.
  4. Selection of Drug : Haridradi gana and Morden Oral Antihyperglycemic Drugs for Group A (Trial Group) and Group B. (Control Group) respectively selected.

 

 

METHODS :-

This is an open randomized control clinical study on Haridradi gana for Group A as a Trial Group and Modern Oral Antihyperglycemic Drugs for Group B as a Control Group in management of Type II DM, which was carried out in the O.P.D./I.P.D. of Dept. of Kayachikitsa. Patients were diagnosed on the basis of clinical signs and symptoms described in Ayurveda and Modern medicine.  Also by testing blood sugar level i.e. fasting and post prandial.    Group A patients – kwath of  Haridradi gana was given for 60 days orally before meals twice a day and Group B patients were given Modern Oral Anti hyperglycemic Drugs i.e. Tab. Metformin 500 mg before meals twice a day given for 60 days orally.  Assessment was done on Day 0, 15th, 30th, 45th and 60th day.

1

Method of preparation of the drug – The method used for preparation of kwath was as described in Sharangdhara samhita.

 

Drug manufacturing: – All raw drugs required for manufacturing the drug had been collected from local market and it identified and prepared under the guidance of Dravyaguna and Rasashastra experts of M.S. Ayurvedic Medical College, Hospital & Research Institute. Gondia (M.S.).

 

Analytical study – Drugs Standardization:-

It has been done at recognized pharmacy after preparation of drug before the clinical trials.

Clinical Study: Flow Chart Diagram-

2

INCUSION CRITERIA:-

  1. A) Subjective Criteria:

1) Newly diagnosed patients of type II DM

2) Patients of both sex included.

3) Irrespective of caste and religion.

4) Irrespective of socioeconomic status.

 

  1. B) Objective Criteria:
  2. a) Patients of type 2 diabetes fulfilling the standard diagnostic criteria of the World Health Organization (WHO) for DM: Symptoms of DM pus random blood glucose >200mg/dl of fasting blood glucose >126 mg/dl or 2-h blood glucose >200 mg/dl during an oral glucose tolerance test.
  3. b) Measurement of Lipid Profile

 

Exclusion Criteria –

  1. Type I DM
  2. Patient of type II DM is on insulin therapy i.e. IDDM.
  3. Patients having medical emergencies associated with Type II DM like

Coronary Heart disease, Atherosclerosis, CCF, Myocardial infarction, nephropathy, Tuberculosis, carcinoma and human immunodeficiency virus  positive patients etc.

  1. Patient suffering from endocrinal disorder like, thyrotoxicosis, Cushing syndrome, thyrotoxicosis, Cushing syndrome etc. were also excluded.

 

 

Investigation:-

CBC, Lipid profile, ESR, urine for routine and microscopic examination.

Biochemical investigations (fasting blood sugar, post prandial blood sugar, blood urea, serum creatinine, and serum insulin in selected patients) were performed.

3

  1. B) Objective Criteria:
  2. a) Patients of type 2 diabetes fulfilling the standard diagnostic criteria of the World Health Organization (WHO) for DM: Symptoms of DM plus random blood glucose >200mg/dl of fasting blood glucose >126 mg/dl or 2-h blood glucose >200 mg/dl during an oral glucose tolerance test.
  3. b) Measurement of Lipid Profile

 

Criteria of Overall assessment of treatment results:

0          No relief                      0%

1          Mild relief                   25%

2          Moderate relief           50%

3          Maximum relief           <75%

 

OBSERVATION AND RESULTS:

1)  Observation and results are subjected to statistical analysis.

2) To compare the effect of therapy of the two groups Chi square (X2) test was carried out for subjective criteria and unpaired “t” test for objective criteria. The obtained results were interpreted as follows:

  • Insignificant >0.5            Highly significant <01
  • significant <5                   Highly significant < 0.001

3) Both the groups had shown a significant relief in most of the chief complaints, associated complaints and brief psychiatry rating scale in graphs 1,2&3. On comparison by Chi square test both the groups were equally effective in reliving all the chief complaints, associated complaints and brief psychiatry rating scale.  The effect of Haridradi gana on strotodushti is shown in Graph 4.

4

Graph 1 : Effect on chief complaints

5

Graph 2 : Effect on associated complaints

6

Graph 3 : Effect on brief psychiatry rating scale

7

Graph 4 : Effects on Strotodrushti

Both group A and Group B showed a significant (P<0.001) decrease in FBS by 14.89% and 16.86% respectively (Table2), and PPBS by 16.38% and 17.61% respectively (Table3).

8

9

4) Haridradi gana showed a significant decrease in the serum cholesterol level by 16%,serum triglyceride level by 19% and serum HDL level by 7%.On comparison with the test of significance, by the unpaired ‘t’ test, Group A was significantly (P<0.05)better than Group B.

5) The effect of Haridradi gana on Urine sugar is shown in the Tables 7 respectively.

Mode of action of Haridradi gana :

Probable Rasapanchaka of Haridradi gana according to cumulative properties:

Rasa    : Tikta (bitter)+++, Madhur (sweet)++, Kashaya (astringent)+++

Guna   : Ruksha (dry) +++, Guru (Heavy)+, Ushna (Hot)+++

Veerya:  Ushna (Hot)++++, Sheet (Cold)+

Vipaka: Katu (Pungent)+++, Madhur (Sweet)++

Defending part : Madhur (Sweet) rasa

Haridradi gana contain the drug especially Yashtimadhu which has madhur rasa the purpose of using Yashtimadhu in this haridradi gana for getting the Bruhaniya effect. Madhura rasa prevents Dhatukshaya and Vata Prakopa Moreover, it may show a shaman effect on Pitta and Vata in Pittanubandhaja and Vatanubandhaja Kaphaja Prameha, respectively.

Acting Part :Tikta (Bitter) rasa :

लेखन: क्लेदमेदोवसालसीकापूयस्वेदमूत्रपरिषपित्तश्लेष्मोपशोषण:

रूक्ष: शीतोलघुश्च |

Kashaya (Asrtingent) rasa:

“शरीरक्लेदस्य उपयोक्ता शोषण: स्तम्भन:

“श्लेष्मापित्तरक्तप्रशमन: रुक्ष शीतो गुरुश्च |

It seems that both Tikta and Kashaya (bitter and astringent) rasa play both acting and defending roles.  By the virtue of Ruksha (dry) property, they especially do Kleda shoshana and Kledopayoga, which is one of the prime dushya in pathogenesis of prameha.

Whereas by Sheeta (cold) property, they prevents liquefaction of the already drava shleshma,

abaddhameda and other AP pradhana dushyas involved in the pathogenesis hence also participating in a defending phenomenon.

Ruksha(dry)guna:

;L; “kks’k.ks “kfDr%A ¼gsekfnz½

cgq nzo “ys’ek +  vc/n esn + Dysn “kks’k.k

In Samprapti of Madhumeha, Bahu drava shleshma is important among the dosha and Abddha meda among the dushyas.  Other dushyas involved are either Bahu of Bahu and Abddha, indicating excessive Ap dhatu in the body and main line of treatment for excessive fluid is their shoshand, which is done by Ruksha (dry) guna Thus, directly or indirectly, Ruksha guna plays a very important role in Samprapti vighatana starting from the very initial stage, i.e. first kriyakala of Sanchaya.

DISCUSSION:

In ancient ayurvedic text, madhumeha has been mentioned along with its appropriate management in detail.Haridradi Gana has been advocated by Acharya Vagbhat in Ashatang Hriday in Sanshodanadi Ganasangraha chapter no 15,shlok 35-36.,so with this reference, we attempted the study.our aim is to study efficacy of Haridradi gana in the management of Madhumeha. Objectives of present study were to review ancient & modern literature in details, to establish correlation between Madhumeha and type2 DM,to study pharmacological action of Haridradi gana.  It has been found that both group has shown satisfactorily decrease in blood glucose level, but group A patients didn’t have any adverse or unwanted effects. As, most of the time DM is associated with HT,IHD,Dyslipidemia,Renal problem etc.Haridradi gana has found to be beneficial in such conditions.

Polyphagia: Here the drugs present in Haridradi gana, such as Haridra, Daruharidra, Indrajav deserves Dipan and Pachan properties which might have the digestive process in the patients by correcting Dhatvagnimandya    and prevents medovruddhi.  Those drugs are also responsible for alleviates the vata dosha responsible for atiagni sandhukshana.  If Kshudhadhikya has occurred due to tikshna and ushnaguna of Pitta, the drugs in the Haridradi gana   such as Yashtimadhu may act by pacifying it with the help of its Sheeta Veerya.

Polydypsia: Trishnadhikya (polydypsia and Gala talu shosha (dryness in mouth) occur due to Pitta Vriddhi and udaka kshaya which may be pacified by Tikta (astringent), Madhur (sweet) and Kashaya (astringent) rasa of the drugs of Haridradi gana such as daruharidra, haridra, yashtimadhu, indrajav that affects the condition by correcting Pitta dosha or due to the trishna nigrahana, pittghana, pittashamak effect of Yashtimadhu and prushniparni.    In same manner it also shows an effect on Gala Talu shosha (dryness in mouth).

Polyuria:  Haridradi gana such as Haridra, daruharidra, Indrajav is dominant in Tikta (bitter) – Kashaya (astringent) rasa and Ruksha (dry) guna among which Tikta (bitter rasa is said to be “kleda upashoshna” which Kashaya )astringent rasa to be “sharira kledasya upayokta”  The word Ruksha itself indicates dryness,  which in turn means lack or decrease of kleda thus, all these are dominant properties show Kleda reducing effect.  Bahu drava Shleshma is the dosha vishesha and Kleda is once of the dushya vishesha in Samprapti of prameda; thus the dominating these properties directly affect both the dosha and the dushya vishesha and hence effectively counteract the Samprapti.

Karapadatala Daha and Karapadatala Suptata (burning sensation and numbness in palm and foot) : Therefore when hyperglycemia is corrected with hypoglycemic activity of Haridra, Daruharidra, Yashtimadhu, Indrajav and Prushniparni, ingredients of Haridradi gana, relief was obtained in those neuropathic complication like Karapadatala daha and KarapadatalaSuptata (burning sensation and numbness in palm and foot), Haridra, Daruharidra, Yashtimadhu, Indrajav and Prushniparni are said to be Nadibalya, and are thus beneficial in neurological symptoms.

Karapadatala Daha (burning sensation in palm and foot) is due to Pitta by provocation of Ushma quality or may be due to loss of Udaka, which might have been pacified by Sheeta quality of Yashtimadhu and PrushnaparniKarapadatala suptata (numbness in palm and foot) is due to Vata– decrease in Chala guna of Vyana vayu that might have been compensated by Sara guna of Haridradi gana.

Daurbalya (weakness), Pindikodweshtana (leg cramps) and Shrama (fatigue) : In madhumeha patients obesity (Sthaulya) may be the cause for manifestation of these symptoms such as Daurbalya (Weakness) and Shrama (fatigue) as, due to Medodhatvagnimdndya, only fat accumulates in large quantities in the body making the person incapable of all activities.  Haridradi gana through its tikta-kashaya (bitter-astringent) rasa and ruksha (dry) guna dose shoshana of abadhya meda and through the Dipana and Pachana properties present in its ingredients like Haridra, Daruharidra,  Indrajav may have corrected digestive process resulting in correction of medhodhtvagni and reducing the baddha meda.  The ingredients like Haridra, Daruharidra, Yashtimadhu, Indrajav present in haridradi gana have medohar properties which may help in reducing excessive medas and thereby reliving these complaints.  In madhumeha the dhatus get vitiated and get converted in to sharir kleda and is excreted though urine.  As a result, Dhatukshaya takes place with manifestation of Dourbalya and shrama.  In Pindikodweshtana (leg cramps), significant results where obtain by the Rasayan effect of Haridra.   Atisweda (excessive sweating): is the symptom that arises due to medo mala vriddhi.  This is due to its ruksha (dry) guna, Kashaya (astringent) rasa, Tikta (bitter) rasa has medohara property due to which it decreases meda and ultimately, its mala i.e. sweda.  These properties directly, also, contribute to the adsorption of sweda.

Stress blocks the body form releasing insulin in people with type 2 diabetes; therefore cutting stress is very essential for effective control of the bold sugar level.  The ingredients present in the

formulation Haridradi gana have different properties that may be helpful in minimizing the stress response or cutting stress.  As Haridra and Daruharidra and antistress as well as antidepressant, they might have been minimizing the stress directly.  The antioxidant property, Rasayana effect and immunomodulatory property of Haridra and Daruharidra might have help in minimizing the stress response, and in the manner controlling the disease.

 

CONCLUSION:

Group A and Group B have shown almost the same effect in decreasing the fasting blood glucose as well as post meals blood glucose level.  In Group A most of the ingredients of Haridradi gana have known anti hyperglycemic, hypolipidemic, hypocholesterolemic, hepatoprotective, antistress, antioxidant and immunomodulatory effects. This study shows significant results of Haridradi gana by decrease in the fasting and post meal plasma glucose level along with the decrease in there Lipid Profile Values without any adverse effect.

Group B patients shows satisfactory results by decrease in the fasting and post meal plasma glucose level but some side effects such as flushing, excessive sweating, drug dependency and habit forming tendency are noticeable.

 

Acknowledgement:

I would like to thanks and acknowledge to my guide respected Dr. Suresh Katre Professor Kayachikitsa Department for guiding, supporting and encourage me to work on this topic.  Also I would like to thanks to my coleuges PG Students of Kayachikitsa department of M.S. Ayurvedic Medical College, Hospital & Research Centre Gondia for helping me in this work.

Bibliography:

  1. Acharya Yadavji Trikamji, Dravyaguna Vijnana (I & II Part), Edition 1997.
  2. Baghel M.S., Researches in Ayueveda.
  3. Chunekar Krishnachandra, Bhavaprakash Nighantu.
  4. Dwarkanath C., Digestion&Metabolism in Ayurved.
  5. Chopra R.N., Indigenous Drugs of India, Colonel.
  6. Desai Ranjit Rai,, Ayurvediya Kriyasharir.
  7. Deb A.C., Fundamentals of biochemistry.
  8. Davidson, Principles & Practice of Medicine.
  9. Gupta Kaviraj Atridev, Ashtanga Hridaya, With Vidyotini hindi commentary.
  10. Gupta Kaviraj Atridev, Sushrut Samhita, With Ayurved Tattva-sandipika hindi  Commentary, 13th Edition  2002.
  1. Harrison, Principles of Internal Medicine, Edition. 2010.
  2. Kirtikar K.R. & Basu B.D., Indian Medicinal Plant.
  3. Harshmohan, Textbook of pathology harshsmohan.
    1. Mahajan B.K., Methods in Biotatatistics, Edition 2010.
    2. Nadkarni K.M., Indian Materia Medica (vol I,II), 3rd Edition.
    3. Rastogi, CDRI Lucknow (U.P.), The compendium of Indian Medicinal Plants.
    4. Sharma P.V., Dravyaguna Vijnana (I & II Part), Edition.2000
    5. Shah Vaidya Nagindas, Bharat Bhaishajya Ratnakar
    6. Tripathi Bramanand, Charak Samhita , with Charak chandrika hindi commentary, Edition 2002.
    7. Tripathi Brahmanand, Sharangdhara samhita.
    8. Tripathi Indradev, Chakradatta of Sri Chakrapani, With Vaidyaprabha hindi commentary 2nd Edition 1994.
    9. UpadhyayYadunandan, Madhava Nidan, With Madhukosh sanskrit commentary by Sri

          Vijayrakshit & Srikanthadatta with Vidtotini hindi commentaryedited, 32nd Edition 2002.

AUTHOR
Profile photo of SANDESH GOJE
SANDESH GOJE

Ayurveda Specialists

0.7
KOL
1
Followers

Leave a Reply

Your email address will not be published. Required fields are marked *