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CLINICAL RESEARCH
Year : 2014  |  Volume : 35  |  Issue : 4  |  Page : 378-383  

Management of Madhumeha Janya Upadrava with special reference to diabetic nephropathy - A clinical study


1 Department of Kayachikitsa, Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar, Gujarat, India
2 Department of Panchakarma, JSS Ayurveda Medical College, Mysore, Karnataka, India

Date of Web Publication18-Jun-2015

Correspondence Address:
A M Akarshini
No. 48, 3rd Floor, 7th Main, 4th Cross, Subbanna Garden, Vijaynagar, Bangalore - 560 040, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-8520.158987

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   Abstract 

Background: Diabetic nephropathy (DN) is a microvascular complication of diabetes mellitus. As the disease DN manifests secondary to Madhumeha, the disease is termed as Madhumeha Janya Upadrava. The diagnosis of DN is microalbuminuria is a powerful screening tool in screening DN earlier stages. A diabetic can develop nondiabetic renal disease like anyone, but the finding of diabetic retinopathy strongly suggests that any proteinuria is due to diabetic glomerulosclerosis. In this dissertation, all diabetic patients who showed positive diabetic retinopathy changes; were screened for 24 h microalbuminuria, at its earlier asymptomatic period itself. This research work is specially intended to instigate effective therapies at earlier stage itself, thereby prevent further progression. Aim: To evaluate the combined effect of Shilajitvadi Vataka, Punarnavadi Mandura, Triphala Guggulu and Pippalimooladi Paneeya added with Amrita and Bringaraja in DN. Materials and Methods: Single blind clinical study with pre-test and post-test was designed. The study conducted on 15 patients of both sex aged between 20 and 80 years, having DN changes through assays for microalbuminuria and other biochemical assays; along with prior confirmation of diabetic retinopathy changes. The duration of the study was 48 days and patients were assessed on every 15 days. Results: After 48 days of treatment, statistically significant improvement in levels of microalbuminuria with mean difference 83.76 μg/24 h, highly significant improvement in status of Agni and statistically no significant improvement in glomerular filtration rate by 2.381 mL/min/1.73m 2 . No significant side-effects were observed. Conclusion: Overall the study showed encouraging results in treating the malady DN.

Keywords: Diabetic nephropathy, glomerular filtration rate, Madhumeha Janya Upadravas, microalbuminuria, retinopathy


How to cite this article:
Akarshini A M, Aruna. Management of Madhumeha Janya Upadrava with special reference to diabetic nephropathy - A clinical study. AYU 2014;35:378-83

How to cite this URL:
Akarshini A M, Aruna. Management of Madhumeha Janya Upadrava with special reference to diabetic nephropathy - A clinical study. AYU [serial online] 2014 [cited 2020 Feb 26];35:378-83. Available from: http://www.ayujournal.org/text.asp?2014/35/4/378/158987


   Introduction Top


Diabetic nephropathy (DN) is a disorder afflicting the kidneys, in the form of damage to the glomerular basement membrane, mesangial cell proliferation and glomerulosclerosis. DN is the third leading cause of death, among end-stage renal disease (ESRD) patients. [1] It accounts for 25-40% of all cases with ESRD, after over 6-25 years and 0-8 years of manifestation of insulin-dependent diabetes mellitus (IDDM) and non insulin-dependent diabetes mellitus (NIDDM) respectively. Metabolic derangements are present in diabetes patients from the onset itself; which contributes to hyperglycemia. This in turn activates four major pathways [2] of hyperglycemic damage such as nonenzymatic glycosalation, polyol pathway, hexose monophosphate shunt pathway and protein kinase C pathway mainly. Resulting in overproduction of superoxide that is a reactive oxygen species; thereby leading to oxidative stress and glomerular damage.

In Ayurveda, direct nomenclature of DN is not found. Regarding the manifestation of Upadrava (~complications) in Madhumeha patients its stated as, the Dushita Medas (improperly formed fat tissue) along with Kapha, does Dooshana of Kleda and gets transformed to Mootra (~urine). This cause obstruction at the Mootravaha Srotas and transforms Madhumeha into incurable form leading to manifestations of Upadrava.[3]

Diabetic nephropathy presents with hyper filtration first, followed by renal hypertrophy, microalbuminuria, and hypertension (HTN), later proteinuria and ESRD. Proteinuria on a long run manifests with pitting oedema as a resultant of hypoalbuminaemia. This symptom can be equated with Kaphaja Shotha explanation, which states "Nipeeditho Na Cha Unnamati0" (swelling of pitting) nature. [4] There are no references suggesting manifestation of Shotha, as an Upadrava of Madhumeha. It could be considered as the resultant of Basti Marmabhighata. [5] Ayurveda has identified the organ system "Basti" as the Moola of Mootravaha Srotas, and it's an organ, which interpolates the whole of the urinary system. The involvement of Mootravaha Srotas in Madhumeha Samprapti exists from the very beginning of its pathogenesis. Basti Marmabhighata can be a sequel due to the Ksharana (passage) of Uttarottara Dushya[6] in the urine.

There is no specific treatment available at present in contemporary science. The optimal therapy for this is prevention; [7] as it necessitates dialysis, which is much cumbersome. Life style modification is an integral part in its management where a moderate protein diet, low sodium and low potassium diet is encouraged. Considering DN under Yapya Vyadhi is precise, where even a slight variation in the diet brings about increase in proteinurea, which is explained in classics with the lines Pathyahara Viharairryapyo Yapaneeyaha. [8] The diseases involving Marma can be counteracted by careful intervention through use of Rasayana drugs. [9] The use of Rasayanas such as Shilajatu, Mandoora Bhasma, Guggulu, Triphala are taken in the present work, keeping the above in mind.

Study objective

To evaluate the combined effect of (1) Shilajitvadi Vataka, (2) Punarnavadi Mandura, (3) Triphala Guggulu, (4) Pippalimooladi Paneeya added with Amrita and Bringaraja on Madhumeha Janya Upadrava with special reference to DN.


   Materials and Methods Top


Design of study

This is a single-blind observational clinical study with pre- and post-test design.

Source of data and sampling methods

Source of data


A total of 23 patients suffering from Madhumeha Janya Upadrava (DN) were selected randomly from outpatient department, inpatient department and also special camp conducted for the purpose of the institution. Subjects were enrolled in the study after taking their informed consent. Eight of these patients lost to follow-up, and the study was completed on 15 patients. The study was conducted after the ethical clearance obtained from the Institutional Ethics Committee.

Reason for dropouts

In the present clinical study, 23 patients were registered out of which 8 dropouts were observed due to following reasons. One patient had scrotal swelling at the time of admission for the study, as his condition progressed to generalized edema it was discontinued. Another patient had peripheral neuropathy where the patient symptoms was not been able to monitor only with the above medications taken for the study, so to avoid bias it was not taken. Rest all patients failed to come for follow-up even after repeated phone contact. Probably as the patients were screened in earlier asymptomatic period; based on values of microalbuminuria, the meticulous awareness toward disease status was lacking, even after exhaustive clarification. As the patient was not sentient enough to understand the upshot of the disease.

Inclusion criteria

  • Known case of diabetic patients since 0-30 years, of either sex, aged between 20 and 80 years, who showed positive results for diabetic retinopathy changes were included
  • Asymptomatic/symptomatic diabetic patients who are afebrile, who have not done any vigorous exercise in previous 48 h, showing positive results for microalbuminuria (>30 μg/24 h) with or without macroalbuminuria were selected
  • Both fresh and treated cases were included.


Exclusion criteria

  • Patients having other complications of diabetes like cardiomyopathy were excluded
  • Patients with recurrent urinary tract infections, marked HTN or obesity were excluded, as these conditions fallaciously rise microalbuminuria
  • Patients with hyperkalemia and other uremic symptoms are excluded
  • Patients having other systemic disorders which interfere with the course of treatment are excluded.


Diagnostic criteria

  • Fundoscopy - shows diabetic retinopathy changes
  • Laboratory investigations - 24 h microalbuminuria with or without changes in serum albumin, serum creatinine, blood urea.


Investigations

Special investigations


  • Ocular fundoscopy
  • Microalbuminurea - by 24 h urine protein analysis
  • Macroalbuminuria - Urine for microscopic examination
  • Serum albumin
  • Serum creatinine
  • Blood urea nitrogen.


Nonspecific investigation

  • Blood for hemoglobin percentage, total blood count, differential count, erythrocyte sedimentation rate, fasting blood sugar (FBS), postprandial blood sugar (PPBS)
  • Urine routine investigations - Urine sugar, albumin and microscopic analysis.


Other investigations: If necessary, in concluding DN and excluding other forms of diabetic renal disease.

Interventions

  • Shilajatvadi Vataka[10] - 1/2 karsha (6 g) twice a day empty stomach with 100 mL of milk, before food
  • Punarnavadi Mandoora[11] - 2 g, 3 times a day after food
  • Pippali Mooladi Paneeya[12] - added along with Amrita[13] and Bringaraja-approximately 30 mL, twice a day, before food
  • Triphala Guggulu[14] - 3 g, twice a day, after food along with Pathya Aahara and Vihara.


The dose of the medicines was altered considering the condition of the patient. Total duration of treatment was for 48 days. During the treatment period general condition assessment was done once in 15 days. Follow-up period was for 2 months.

Assessment and follow-up

Response of the treatment was evaluated on the basis of score system from 0 to 3 (see criteria of assessment), where change of score indicates clinical improvement or deterioration. Effect on swelling was measured with measuring tape. The glomerular filtration rate (GFR) was measured using Cockcroft-Gault equation:



Multiply by 0.85 for women. [15]

All patients were assessed for general condition at 15 days interval until 48 th day of the treatment. Later follow-up for 2 months. GFR - Grading was done from 0 to 3. [16] GFR is not a significant indicator of glomerular damage in early stages of DN. Microalbuminuria is a better indicator for progression and also to decide the prognosis of renal disease in earlier stages. [17]

Efficacy and safety parameters

Efficacy variable


The efficacy variables were subjective parameters like Akshikoota shotha (retro orbital oedema), Pada Shotha (pedal edema), Dourbalyata (fatigue), Agnimandhya (loss of appetite), and objective parameters like microalbuminuria, serum albumin, serum creatinine, GFR, blood urea and albuminuria (AL), blood pressure and FBS and PPBS.

Safety variable

Any side-effects as experienced by the patient or observed by the investigator during the course of treatment with the study drug were recorded in case record form.

Criteria of assessment

Glomerular filtration rate


  • Criteria: Score
  • Severe: <15 mL/min/1.73 m 2 -3
  • Moderate: <30-90 mL/min/1.73 m 2 -2
  • Mild: >125 mL/min/1.73 m 2 -1
  • Normal: 125 mL/min/1.73 m 2 -0.


Albuminuria

  • Criteria: Score
  • Severe: <15 mL/min/1.73 m 2 -3
  • Moderate: <30-90 mL/min/1.73 m 2 -2
  • Mild: >125 mL/min/1.73 m 2 -1
  • Normal: 125 mL/min/1.73 m 2 -0.


Microalbuminuria (24 h)

  • Criteria: Score
  • Abnormal: >200 μg/min% - 3
  • Moderate: 100-200 μg/min% - 2
  • Mild: >30-100 μg/min% - 1
  • Normal: <30 μg/min% - 0.


Pada Shotha (Pedal oedema)

  • Criteria: Score
  • Severe: 3
  • Moderate: 2
  • Mild: 1
  • Normal: 0.


Akshikoota Shotha (retro orbital oedema)

  • Criteria: Score
  • Severe: 3
  • Moderate: 2
  • Mild: 1
  • Normal: 0.


Statistical analysis

Assessment of the patients was done before the treatment, after 15, 30 and 48 th day the treatment. The data were collected and analyzed, the total score of before treatment, during and after treatment was assessed using students paired t-test, descriptive statistics and contingency coefficient. Analysis was done through SPSS (Statistical Presentation System Software) for Windows, version 14.0, evaluation version (SPSS, 2005, SPSS Inc., New York, NY, USA).

Observations

Most of the patients (66.7%) were of 60-80 years of age, followed by 20-40 years of age (20%) found prone to DN. Out of total 15 patients 9 (60%) were males and 6 (40%) were females. In study type 1 diabetic patients outnumbered type 2 diabetics (60% vs. 40%), maximum number of patients (10 i.e. 66.7%) showed familial inheritance of DM, 53.3% patients developed DN after 1-10 years duration of diabetes 86.7% had association of HTN along with DM. Maximum number of patients that is, 10 (66.7%) of them had mild nonproliferative diabetic retinopathy (NPDR), 4 (26.7%) had moderate NPDR. Presence of retinopathy changes was included only as a screening, so as to differentiate from other forms of diabetic renal disease; no post treatment retinopathy screening done.


   Results Top


Effect of therapy

Subjective parameters


There was symptomatic improvement in Pada Shotha (pedal edema) [Figure 1], Akshikoota Shotha (retroorbital edema) [Figure 2]. Urine volume and weight was within normal in most of the patients. These parameters showed no significant improvement statistically. The Agni status assessed as either Manda, Madhyama or Teekshana. Statistically highly significant improvement was observed in Agni status [Figure 3].
Figure 1: Improvement in Pada Shotha (~pedal edema)

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Figure 2: Improvement in Akshikoota Shotha

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Figure 3: Improvement in Agni status

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Objective parameters

Significant improvement was observed in microalbuminuria. The difference of pre- and post-test mean of 83.76 μg/24 h. The mean increase in GFR in study subjects was about 2.3813, which showed statistically insignificant association [Table 1]. The mean serum albumin in the study subjects remained stable during the study period. Statistically, it showed insignificant improvement. Stable serum albumin levels may further indicates that there was no significant proteinuria in the study subjects. The mean difference of pre- and post-serum creatinine test was 0.1133, which showed statistically insignificant decrease [Table 1]. The improvement denotes prognosis only in late stages of DN, as serum creatinine is known to be late biomarker in DN. Statistically insignificant increase was seen in blood urea levels with a mean difference of −1.3000.
Table 1: Effect therapy on biochemical parameters (n=15)

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The mean difference in FBS was 13.20 mg/dl which showed statistically insignificant association and in PPBS the mean difference was 19.33 mg/dl which showed statistically insignificant association [Table 1].

Systolic pressure decreased by 6 mmHg, diastolic pressure decreased by 3 mmHg, and mean arterial pressure decreased insignificantly [Table 2]. In AL overall improvement individually was good, but statistically insignificant improvement [Table 3].
Table 2: Effect therapy on blood pressure (n=15)

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Table 3: Effect of therapy on albuminuria

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Long term administration on the same medicaments had shown encouraging results. One patient was on dialysis since 6½ months. Had underwent 79 dialysis, had GFR 10.83 before treatment, which increased to 13.41 after 48 days of treatment and further rose to 25.60 mL/min/1.73 m 2 with lowering of serum creatinine levels from 5.2 to 2.2 after 8 months of treatment. As it's the late biomarker in DN, [18] the improvement in the creatinine levels shows the prognosis. Finally the patient was stopped from dialysis after observing the above improvement in GFR. Thus researches should be directed in this field to prove the effectiveness of the combination in DN patients, only then the generalization of effect in dialysis could be made.

Safety evaluation

Most of patients showed inconvenience with ingestion of medication, in particular to odor of Gomutra (cow's urine) in Punarnavadi Mandoora and Triphala Guggulu. The patients were counseled for the same, thereby continued. Three patients complained of Urodaha (burning sensation in epigastrium) with Pippalimooladi Paneeya, such patients were advised to reduce to once daily dosage. If symptoms persisted then, during such symptomatic period the medications were discontinued for few days and was later restarted.


   Discussion Top


Shilajatu is a time tested drug and regularly used by Ayurvedic practitioners in renal disorders with assured effects. The active principle in Shilajatu is fulvic acid. Fulvic acid significantly increased superoxide dismutase activity. [19] Experimental studies showed that fulvic acids diminished the development and progression of diabetes, and assisted in the treatment. [19] Shilajatu Punarnava, Guggulu, Mandoora, Triphala are drugs said as Naimittika Rasayanas beneficial in Prameha, Shotha, and in renal disorders. Furthermore, the combination was found effective by experts in clinical practice and hence the above combination selected. Hence, Naimithika Rasayanas act as an adjuvant to the specific Vyadhihara Chikitsa prescribed for the disease and enhances their effect. These clear the Srotas (channels of circulation) by clearing the Aparipakwa Medas which is the main culprit formed as a result of Dhatwagnimandhya. The ingredients of Pippalimooladi Paaneeya have Deepana (stomachic), Pachana (digestive), Shothahara (reduces swelling), Bastishodhaka (clears renal pathway) and Kaphahara (removes the adherent dosas causing obstruction in renal vasculature) actions. Thus, it helps to remove the obstruction at glomerulus and also peripheral circulatory vessels. Thus by cleansing and activating the micro-circulatory channels, circulation and tissue perfusion will be increased thereby providing sufficient nutrition to the tissues.

Fundoscopy was included as a diagnostic criteria to confirm the renal disease is due to diabetes; as it's stated that - A diabetic can develop nondiabetic renal disease like anyone but the finding of diabetic retinopathy strongly suggests that any proteinuria is due to diabetic glomerulosclerosis. [20] Thus in the study the prognostic assessment of the same was not done.

The outcome of treatment after 48 days showed statistically significant improvement in levels of microalbuminuria, highly significant in Agni improvement, and improvement in GFR by 2.3813 mL/min/1.73 m 2 that was statistically nonsignificant. The drug combination has been shown encouraging results in a patient on dialysis with improvement of GFR from 10.83 to 25.60 mL/min/1.73 m 2 . This patient was stopped dialysis; thus administering medication for longer duration could be beneficial. Thus researches should be directed in this field to prove the effectiveness of this, in DN patients in later stages, only then the generalization of effect in dialysis could be made.

The drugs also found effective to stabilize the risk factors of DN like blood glucose levels, HTN as well. During the study period, the weight of patients and values of serum creatinine, serum albumin, blood glucose were stable without much variation, which shows that the drug combination is effective enough to monitor the risk factors of DN and prevent the disease from further progression.


   Conclusion Top


Microalbuminuria is the powerful screening tool for diagnosis and prognosis of DN in early stages. Statistically significant improvement in microalbuminuria has proved the effectiveness of the drugs used in the study in retarding the progression of glomerular injury. The work has shed a ray of hope in management strategy for DN. The beneficial effects of Rasayana drugs can be established thereby. Research efforts can be instituted in larger samples for further precision.

 
   References Top

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Dhinakaran T. Diabetic nephropathy-newer concepts in diagnosis and management, The Diabetes Organization. Available from: . [Last updated on 2003 Mar 23].  Back to cited text no. 1
    
2.
Powers AC. Diabetes mellitus-mechanisms of complications. In: Kasper DL, Braunwald E, Anthony S, Stephen L, Dan L, Larry J, editors. Text Book of Harrison′s Principles of Internal Medicine. 16 th ed. Vol. II. New York: McGraw-Hill Medical Publishing Division; 2005. p. 2162.  Back to cited text no. 2
    
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Chakrapanidatta, Commenttator. Charaka Samhitha, Nidanasthana, Prameha Nidana Adhyaya, 4/8, 2 nd ed. Chowkhamba Sanskrit Samsthan, Varanasi, 2007; 213.  Back to cited text no. 3
    
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Agnivesha, Charaka, Dridhabala, Charaka Samhitha, Chikitsa Sthana, Swayathu Chikitsa Adhyaya, 12/14, edited by Vaidya Jadavji Trikamji Aacharya, 2 nd ed. Chowkhamba Sanskrit Samsthan, Varanasi, 2007; 484.  Back to cited text no. 4
    
5.
Ibidem, Charaka Samhitha, Chikitsa Sthana, Shwayathu Chikitsa Adhyaya, 12/1; 482.  Back to cited text no. 5
    
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Cakrapanidatta, commenttator. Charaka samhitha, Chikitsa Sthana, Prameha Chikitsa Adhyaya, 6/8, 2 nd ed. Chowkamba Sanskrit Samsthan, Varanasi, 2007; 445.  Back to cited text no. 6
    
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Powers AC. Diabetes mellitus-mechanisms of complications- renal complications of diabetes mellitus. In: Kasper DL, Braunwald E, Anthony S, Stephen L, Dan L, Larry J, editors. Text Book of Harrison′s Principles of Internal Medicine. 16 th ed. Vol. II. New York: Mc Graw-Hill Medical Publishing Division; 2005. pp. 2164.  Back to cited text no. 7
    
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Agnivesha, Charaka, Dridhabala, Charaka Samhitha, Sutrasthana, Mahachatushpada Adhyaya, 11/17, edited by Vaidya Jadavji Trikamji Aacharya, 2 nd ed. Chowkhamba Sanskrit Samsthan, Varanasi, 2007; 482.  Back to cited text no. 8
    
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Agnivesha, Charaka, Dridhabala, Charaka Samhitha, Chikitsa Sthana, Pandu roga Chikitsa Adhyaya, 16/88-92, edited by Vaidya Jadavji Trikamji Aacharya, 2 nd ed. Chowkhamba Sanskrit Samsthan, Varanasi, 2007; 530.  Back to cited text no. 10
    
11.
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Prince PS. The antioxidant activity of amrita in alloxan diabetic rats. Available from: http://www.scribd.com/doc/33566616/tinospora-sinesis. [Last cited on 1999 June 10].  Back to cited text no. 13
    
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Sharangadara, Sharangadara Samhitha, Madhyama Khanda, Guggulu Vidhanam, Bhagandaradou, 7/83-84, Hindi Commentary by Ramprasad Vaidhya, 6 th ed. Krishnadas Prakashan, Mumbai, 2006; 145.  Back to cited text no. 14
    
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Skorecki K, Green J, Brenner BM. Chronic Renal Failure-Disorders of kidney and urinary tract-recommended equations for estimation of glomerular filtration rate (GFR)-. In: Kasper DL, Braunwald E, Anthony S, Stephen L, Dan L, Larry J, editors. Text book of Harrison′s Principles of Internal Medicine. 16 th ed., Vol. II, Ch. 261. New York: McGraw-Hill Medical Publishing Division; 2005. pp. 1654.  Back to cited text no. 15
    
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Skorecki K, Green J, Brenner BM. Brenner Chronic Renal Failure - Stages of Chronic Renal Disease In: Kasper DL, Braunwald E, Anthony S, Stephen L, Dan L, Larry J, editors. Text book of Harrison′s Principles of Internal Medicine. 16 th ed., Vol. II, Ch. 261. New York: Mc Graw-Hill Medical Publishing Division; 2005. pp. 1653.  Back to cited text no. 16
    
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Viberti GC, Hill RD, Jarrett RJ, Argyropoulos A, Mahmud U, Keen H. Microalbuminuria as a predictor of clinical nephropathy in insulin-dependent diabetes mellitus. Lancet 1982;1:1430-2.  Back to cited text no. 17
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Rossing K, Christensen PK, Hovind P, Tarnow L, Rossing P, Parving HH. Progression of nephropathy in type 2 diabetic patients. Kidney Int 2004;66:1596-605.  Back to cited text no. 18
    
19.
Bhattacharya SK. Shilajit attenuates streptozotocin induced diabetes mellitus and decrease in pancreatic islet superoxide dismutase activity in rats. Phytother Res 1995;9 (1):41-4.  Back to cited text no. 19
    
20.
Parving HH, Gall MA, Skøtt P, Jørgensen HE, Løkkegaard H, Jørgensen F, et al. Prevalence and causes of albuminuria in non-insulin-dependent diabetic patients. Kidney Int 1992;41:758-62.  Back to cited text no. 20
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]


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