A Clinical Study to Evaluate the Efficacy of Vanga Shilajatu in Madhumeha with Special Reference to Type 2 Diabetes Mellitus - A Study Protocol

Abstract

Background: Madhumeha is made up of the words Madhu and Meha. Madhu means \"sweet,\" and Meha signifies \"excess urination\" (atipravritti/ Bahula Avila Mutrata).Madhumeha is a clinical condition identified as one of the forms of Vataja Prameha in Ayurveda.[1] Avil Prabhuta Mutra is Prameha\'s main feature.[2] Madhumeha is induced by Dhatukshaya and manifests as a thin and asthenic individual as a result of Oja loss or imbalance. The vitiated Kapha and Meda in Margavaranjanya Madhumeha obstruct the path of Vata. The obstructed Vata becomes vitiated again and transports Ojas to Basti, manifesting Madhumeha.[3] Madhumeha is associated with a comparable condition. Diabetes mellitus is a syndrome characterised by abnormal metabolism and hyperglycemia caused by a lack of insulin secretion or a combination of insulin resistance and inadequate insulin production. [4] This study was chosen to evaluate the efficacy of Vanga Shilajatu in Madhumeha (Type 2 Diabetes Mellitus). Aim and Objectives: To study the effect of drug on clinical parameter & biochemical finding associated with Madhumeha (Diabetes Mellitus) and also to advise preventive measures to check the occurrence of disease individuals and masses. Methodology:50 Patient of either sex will be selected from age-group of 25-60 and fulfilling all the criteria’s and will be administered with Vanga-Shilajatu capsules twice a day for 28 days. Results: Result will be decided on the basis of changes in subjective and objective parameters after the treatment. Conclusion: Vanga-Shilajatu may have significant results in Madhumeha (Type 2 Diabetes Mellitus).

Introduction

I. INTRODUCTION

Sedentary lifestyles, bad eating habits, and physical inactivity in the present period attract several metabolic illnesses such as hypertension, ischemic heart disease, diabetes, crystal arthropathy, arthritis, and hyperuricemia. In ancient literature, the Acharyas mentioned an illness called Madhumeha, which resembles Type 2 Diabetes Mellitus in modern studies. Madhumeha is an type of Parmeha. The cardinal feature of the Prameha has been described as Avile Prabhuta Mutrata.[5] Dhatukshaya causes Madhumeha, which manifests as a thin and emaciated individual due to an imbalance in Oja or loss of Oja. The vitiated Kapha Dosha and Meda Dhatu impede the Vata channels in Margavaranjanya Madhumeha. The obstructed Vata Dosha becomes vitiated again, sustaining Ojas to Basti and manifesting as Madhumeha. In classical writings, Madhumeha is referred to as Mahatyaya, which means Mahavyapattikara (creating great problems).

It demonstrates a complex disease process due to the involvement of all three Doshas as well as the majority of body components as Dushyas, including Rasa, Rakta, Mamsa, Medas, Majja, Shukra, Ambu, Vasa, Lasika, Ojas, and Sweda. Furthermore, Asthi's influence cannot be overlooked, as the development of Kesha and Nakha is chronicled in Poorvarupa. To try successful care, ancient Indian physicians classified the condition in several ways, including etiological, pathological, and prognostic perspectives.[6]

Diabetes cases increased from 108 million in 1980 to 422 million in 2014.

Diabetes-related premature mortality increased by 5% between 2000 and 2016. Diabetes was the ninth biggest cause of mortality in 2019, accounting for an estimated 1.5 million deaths. Diabetes mellitus is expected to affect up to 79.4 million people in India by 2030.[7]

Thus, it is demand of time to seek safe and effective ayurvedic treatment. No study has been done on Vanga Shilajatu together for 50 randomly selected Madhumeha patients.Thus this study is taken.

II. REVIEW OF LITERATURE

All Ayurvedic classical literature, including Brih-trayi, Laghu-trayi, and Nighantu, as well as recent text books will be studied. Websites such as PubMed, Google Scholar, Scopes, Articles, Journals, and Research Papers, among others, will be scanned for information on the subject.

III. REVIEW OF MODERN LITERATURE

Diabetes mellitus is a chronic condition caused by an inherent or acquired lack of insulin production by the pancreas, or by inefficient insulin synthesis. Such a deficiency causes an increase in the concentration of glucose in the blood, which damages numerous physiological systems, including the blood vessels and nerves. Diabetes is caused by a combination of pathogenic mechanisms. These range from autoimmune death of pancreatic -cells, resulting in insulin insufficiency, to anomalies that result in insulin resistance. Diabetes is characterised by anomalies in glucose, lipid, and protein metabolism caused by insulin's ineffective action on target tissues. [8]

Drug Review[9]

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IV. METHOD OF PREPARATION

The Vang Shilajatu will be prepared in the form of a capsule containing Vang Bhasm 125 mg and Shuddha Shilajatu 250mg in pure form and it will be administered with water.

1. Need Of Study - The modern medical system's line of therapy focuses mostly on stringent glycemic control, and long-term use of these treatments creates adverse effects such as low blood sugar levels, allergic skin rashes, and bone marrow depression. A better choice is to seek safe and effective ayurvedic treatment. A lot of research has been done on Vanga Bhasma and Shuddha Shilajatu individually for Madhumeha, but no study has been done on Vanga Shilajatu for 50 randomly selected Madhumeha patients. There is a research gap in proving the efficiency of Vanga Shilajatu in Madhumeha (Diabetes) and also there is need to find out the most effective, safe and cheap available management of Madhumeha. 
2. Source Of Data - Total 50 patients of either sex and age group 25-60 will be selected randomly for this study from the OPD & IPD of Kayachikitsa department of Shri Krishna govt. Ayurvedic College and Hospital, Kurukshetra (Haryana), those fulfilling the inclusion criteria and ready to give informed consent.

V. AIM AND OBJECTIVES

1. To study the effect of drug on clinical parameter & biochemical finding associated with Madhumeha (Diabetes Mellitus)
2. To advise preventive measures to check the occurrence of disease individuals and masses. 
3. To standardize an ayurvedic line of treatment both drug and dose which may have an effective role in management of patients of Madhumeha.
4. To explain the Madhumeha on the basis of critical review in classic text of Ayurveda and with the help of modern literature.
5. To provide cheap, safe and effective treatment from Ayurveda to Madhumeha patients.

VI. CASE DEFINITION

A unique proforma will be produced that includes all of the points of detailed history and physical examination specified in Ayurveda as well as modern parameters  Each patient will be assessed using this proforma, which includes a detailed history, signs and symptoms, Nidana panchaka, and other information.

All vital signs such as blood pressure, pulse rate, respiratory rate, and temperature will be closely checked in each patient. All patients chosen for the experiment will be informed about the nature of the study, and their agreement will be obtained prior to the start of the trial.

Type Of Study:  Single centered, simple Random sampling, open label clinical study

Research Question: Efficacy of  Vanga Shilajatu in Madhumeha (Type 2 Diabetes      Mellitus)?

Hypothesis

Alternate Hypothesis (H1): Vanga Shilajatu is significantly effective in the management of Madhumeha (Type 2 Diabetes Mellitus).

Null Hypothesis (H0): There is no significant efficacy of Vanga Shilajatu in management of Madhumeha (Type 2 Diabetes Mellitus).

Type of Study: Single centered, simple Random sampling, open label clinical study

Site of Study - Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra Haryana.

Posology - 1 capsule of Vanga Shilajatu BD (Each capsule contains 125 mg of Vanga Bhasma and 250 mg Shuddha Shilajatu twice a day 15 minutes before meal with water

A. Inclusion Criteria:

1. Patients willing for clinical trials and ready to give written consent.
2. Patients with age between 25-60yrs of either sex.
3. Patients possessing signs and symptoms of Prameha (Diabetes Mellitus).
4. Diagnosed & confirmed cases of Madhumeha on the basis of Diagnostic criteria for diabetes.

Table 01: Diagnostic criteria for diabetes

• * Individuals with random plasma glucose between 140-199mg/dl are recommended to undergo OGTT
• WHO - World Health Organisation; ADA-American Diabetes Association; IFG - Impaired Fasting Glucose; IGT - Impaired Glucose tolerance; FPG - Fasting Plasma Glucose; 2-h PG-2 hour post load Glucose test (oral glucose tolerance test) plasma glucose; HbA1c – Glycosylated Haemoglobin

5. FBS-126-200mg/dl PPBS-200-300mg/dl

6. HbA1c 6.5 % - 7%

B. Exclusion Criteria:

1. Patients not willing for the clinical trial.
2. Patient not fulfilling the inclusion criteria.
3. Patients below the age of 25 years and above the age of 60 years
4. Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl
5. Post Prandial Blood Sugar Level <200 mg/dl and >300 mg/dl
6. HbA1c <6.5% and  >7%.
7.  Patients of Insulin dependent Diabetes Mellitus (IDDM)
8. Patients with diabetic complications such as impaired renal functions.
9. Patients suffering from Secondary Diabetes.
10. Gestational diabetes.
11. Pregnant ladies and lactating mothers.

C. Withdrawal Criteria:

1. Patients developing any serious adverse effects
2. Deteriorations of the condition of the patients after taking treatment
3. Patients not willing to continue in study.

a. Follow Up – Patients will be followed up on every 7 days during the course of therapies to assess variation in symptomatology and to know any complication.

b. Discussion - Madhumeha is induced by Dhatukshaya and manifests as a thin and asthenic individual as a result of Oja loss or imbalance. The vitiated Kapha and Meda in Margavaranjanya Madhumeha hinder the transit of Vata. The impeded Vata becomes vitiated again and transports Ojas to Basti, manifesting Madhumeha. Vanga Shilajatu's contents include Vanga Bhasma and Shuddha Shilajatu. Tikta, Katu Rasa, Laghu, Ruksha Guna, Ushna Virya, and Katu Vipaka would act on the Kapha Dushti in Vanga Bhasma. Mehahara, Gulmahara, Medohara, Agnimandyahara, Kshayaghna, Panduhara, Shosahara, Vranahara, and Shukrakshayahara are some of the names. Shuddha Shilajatu contains Tikta Rasa, Ushna Virya, and Katu Vipaka, all of which will influence the Kapha Dushti. Its Ushna Virya breaks Vata Avarana and has rasayana and vrishya qualities.[10]

D. Subjective Criteria:

All the Symptoms will be  assessmed by using Symptom Rating Scale and thes symtoms are-

1. Avila Mutrata (Turbidity)
2. Mutramadhurya (Glycosuria)
3. Pipasa-Adhikya (Increased Thirst)
4. Kshudha-Adhikya (Increased Appetite)
5. Swedadhikya (Perspiration)
6. Angagandha (Bad Odour)
7. Nidradhikya (Increased Sleep)
8. Hasta-Pada-Tala Dahakara
9. Pada Suptata
10. Prabhuta Mutrata (Polyuria)

E. Objective Criteria

Following investigations will be done for safety of the drugs and to exclude the cases as per the exclusion criteria mentioned earlier 

1. FBS AND PPBS
2. HBA1C
3. CBC
4. Lipid Profile
5. Blood Urea
6. Serum creatinine
7. SGOT
8. SGPT
9. URINE (Routine and microscopic)

Criteria For The Assessment Of Overall Effect Of The Therapies:

The results will be evaluated on the basis of clinical parameters obtained before and after the completion and the assessment will be carried out on further finding in below mentioned tabulated form.

VII. STATISTICAL ANALYSIS

The information gathered on the basis of above observations was subjected to statistical analysis in terms of mean (x), standard deviation (S.D.) and standard Error (S.E.). Necessary and applicable statistical test will be applied.

 The obtained results will be interpreted as:

 Insignificant - P < 0.10

Significant - P < 0.05, < 0.01 

Highly Significant - P < 0.001

VIII. RESULTS

The treatment's results will be tabulated and statistically evaluated using relevant tests, and the level of significance and then it will be published.

Conclusion

The work will be summarized and the result will be concluded after the above mentioned study with the help of statistical data. A. Ethics and Publication The ethical committee has approved the research topic following thorough review and presentation. B. Assent or Consent Subjects will be given detailed treatment information in their native language. Before beginning the trial, patients will be asked to provide written consent.

References

[1] Shastri K., Chaturvedi G., editor. Charak Samhita Vol.1. First Edition. Varanasi. Chaukhambha Bharatiya Academy; 2009. p. 506. [2] Shastri K.A., Shushrut Samhita, Ayurveda tattavasandipika – Hindi vyakhya, purvarth, prameha nidana adhyaye, 2010, Verb 6/6, P 326 [3] Shastri K.,Chaturvedi G., Charak Samhita, Vidyotini Hindi vyakhaya, Prameha Nidana Adhyaye, Prameha Chikitsa Adhyaye, Chaukhamba Bharti Academy, 2009, 4: 530- 541, 6:227-238 [4] Mohan Harsh, Textbook of Pathology, 5th edition, 2005, Chandigarh, India, pg.no- 842. [5] Shastri K.A., Shushrut Samhita, Ayurveda tattavasandipika – Hindi vyakhya, purvarth, Prameha Nidana Adhyaye, 2010, Verb 6/6, P 326 [6] Shastri K.,,Chaturvedi G., Charak Samhita, Vidyotini Hindi vyakhaya, Prameha Nidana Adhyaye, Prameha Chikitsa Adhyaye, Chaukhamba Bharti Academy, 2009, 4: 530- 541, 6:227-238) [7] Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes-estimates for the year 2000 and projections for 2030. Diabetes Care. 2004; 27(3):1047–53. [8] The expert committee on the Diagnosis and Classification of Diabetes mellitus:Reports of the expert committee on the diagnosis and classification of Diabetes mellitus Diabetes Care 1997; 20, pp. 1183–1197 and Diabetes Care 2003; 26, p.3160–3167. [9] Shashti L., Vidyotini tikka, editors. Yoga Ratnakar, Vol.II, First edition. Varanasi, Chaukhambha Prakashan, Chikitsa Sthana, reprint 2020, Prameha Chikitsa, p. 93. [10] Shashti L., Vidyotini tikka, editors. Yoga Ratnakar, Vol.II, First edition. Varanasi, Chaukhambha Prakashan, Chikitsa Sthana, reprint 2020, Prameha Chikitsa, p. 93.

Copyright

Copyright © 2024 Dr. Yadav Neelam, Dr. Kumari Neelam, Dr. Lamba Neha. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.