Efficacy of Ayurvedic/Herbal patent medicines in

Diabetes mellitus as per the claim

INTRODUCTION

Diabetes mellitus — often referred to simply as diabetes—is a condition in which the body either
does not produce enough, or does not properly respond to, insulin, a hormone produced in
the pancreas. Insulin enables cells to absorb glucose in order to turn it into energy. In diabetes, the
body either fails to properly respond to its own insulin, does not make enough insulin, or both. This
causes glucose to accumulate in the blood, often leading to various complications.

The term diabetes, usually refers to diabetes mellitus, which means to excessive sweet urine or
glycosuria ,but there are several rarer conditions also named diabetes. The most common of these
is diabetes insipidus in which large amounts of urine are produced (polyuria), which is not sweet
(insipidus meaning "without taste" in Latin); it can be caused either by kidney (nephrogenic )
or pituitary gland(central ) damage. It is a non-infectious disease

TYPES OF DIABETES

Type 1: Results from the body's failure to produce insulin. Presently almost all
persons with type 1 diabetes require insulin injections.

Type 2: Results from Insulin resistance, a condition in which cells fail to use
insulin properly, sometimes combined with relative insulin deficiency. Many
people destined to develop type 2 diabetes spend many years in a state of Pre-
diabetes. Pre-diabetes indicates a condition that occurs when a person's blood
glucose levels are higher than normal but not high enough for a diagnosis of type
2 diabetes.

Gestational diabetes: Pregnant women who have never had diabetes before but
who have high blood sugar (glucose) levels during pregnancy are said to have
gestational diabetes. Gestational diabetes affects about 4% of all pregnant
women. It may precede development of type 2 (or rarely type 1).

OTHER TYPES OF DIABETES

Maturity onset diabetes of the young (MODY)[1] refers to any of several

hereditary forms of diabetes caused by mutations in an autosomal dominant
gene (sex independent, i.e. inherited from any of the parents) disrupting insulin
production. MODY is often referred to as "monogenic diabetes" to distinguish it
from the more common types of diabetes (especially type 1 and type 2), which
involve more complex combinations of causes involving multiple genes (i.e.,
"polygenic") and environmental factors. MODY 2 and MODY 3 are the most
common forms. The severity of the different types varies considerably, but most
commonly MODY acts like a very mild version of type 1 diabetes, with continued
partial insulin production and normal insulin sensitivity. MODY is not type 2
diabetes in a young person, as might erroneously be inferred from the name.

Various sources have defined "type 3 diabetes" as, among others, gestational
diabetes, insulin-resistant type 1 diabetes (or "double diabetes"), type 2 diabetes
which has progressed to require injected insulin, and latent autoimmune
diabetes of adults (or LADA or "type 1.5" diabetes.

L A D A( type 1.5 diabetes)

Latent autoimmune diabetes in adults (LADA) is a term coined by Tuomi et al in 1993 (Diabetes
42:359-362) to describe slow-onset Type 1 autoimmune diabetes in adults. The Expert Committee on
the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care, Volume 30, Supplement 1,
January 2007) does not recognize the term LADA; rather, the Expert Committee includes LADA in the
definition of Type 1 autoimmune diabetes (“Type 1 diabetes results from a cellular-mediated
autoimmune destruction of the beta-cells of the pancreas. In Type 1 diabetes, the rate of beta-cell
destruction is quite variable, being rapid in some individuals (mainly infants and children) and slow in
others (mainly adults).”) The National Institutes of Health (NIDDK) defines LADA as “a condition in
which Type 1 diabetes develops in adults.” LADA is a genetically-linked, hereditary autoimmune
disorder that results in the body mistaking the pancreas as foreign and responding by attacking and
destroying the insulin-producing beta islet cells of the pancreas. Simply stated, autoimmune disorders,
including LADA, are an "allergy to self.”

Treatment

Several groups of medicines are available in allopathic system of medicine e.g.

Sulfonylureas,Biguanides, Thiazolidinediones, Alpha-glucosidase inhibitors,Peptide
analouges etc. but herbal extracts are also occupied a category among these
groups.

Different patent medicines of different manufacturers composed of various

combination of multiple herbs have widely occupied recent pharmaceutical
market.

In this paper a trial has been conducted regarding the efficacy of such herbal
formulated drug available in current market .

MATERIALS AND METHODS

A herbal drug which is already available in market is selected and it’s efficacy is
compared with the standard allopathic drug Glyclazide (Sulfonylurea group) as
per the claim of the herbal drug manufacturing pharmaceutical company(Green
milk health products ,Apex herbal division).

The safety of this product and the adverse reactions are also studied in this trial.
There were no such adverse effects noticed in case of patients who used this
drug during the trial study.

The herbal drug composed of the multiple herbal extracts composing of

following herbs.

Gymnema sylvestris ,Momordia charantia,Eugenia jambolana,Tinospora

cordifolia,Trigonella foenogricum,Withania somnifera,Cassia
auriculata(Avartaki),aegle marmelos,azadirachta indica,curcuma longa.

This patent drug is selected for the study of the result as per the manufacturer’s
claims of its efficacy in lowering the hyperglycemic conditions in diabetes.
This trial was conducted for a duration of one month only .The hypoglycemic
efficacy or the glucose lowering property of the herbal drug is studied in this
trial.

Three group of patients of age above 40 years were selected for the trial
.Each group composing of 10 patients . One group were supplied with the
Diabetic drug Glyclazide 80 mg. The doses once or twice daily were given as per
the Hyperglycemic condition of the patients. This group is considered as the
control group.

Second group patients were supplied with the herbal drug only .

Third group patients were administered with The combination of medication

composed of the herbal drug with the Sulfonyleurea drug Glyclazide.

All the symptoms were noted .Very common among those were constipation
,fatigueness, Poly urea ,Polydipsia . The sugar level( both fasting and
post pranadial )were also recorded. Other symptoms like recurrent urine
infection ,blurring vision, dyspepsia, were also found in the diabetic patients .

In every 15 days interval the blood sugar of each patient were repeated.

Observation: The group of patients consuming both the herbal drugs and the
glyclazide , got their sugar level to normal in very least time. Out of 10 patients
9 patients feeling normal and the complications like constipation ,fatigueness
,muscle weakness ,palpitation, polyurea, Polydipsia were also absent. Dietary
restrictions were also applied to all these patients.

In case of 1 patient the glucose control was not so effective and took longer
time to make the glucose level to normal in spite of in an increased doses .The
main possible cause is the Obesity and distorted lipid profiles. In this group
patients required low dose of gliclazide . for all patients in this group the blood
sugar level came down to normal range with an average of 21 days.

TABLE NO.1 RESULTS FOR PATIENTS USED BOTH HERBAL DRUG AND
ALLOPATHY DRUG GLICLAZIDE-80Mg.(For a duration of only one month)
P A TIENATGE SEX BLO O D GLU COASE FTER 15 D A YS22D A YS(3W EEK 30D) A YS DO SES O F M EDICIN E
N U M BER F.B.S. P .P .B.S.F.B.S. P .P .B.SF .B.S. P .P .B.S.F.B.S. P .P .B.S.H ERBA LA LLO P A TH Y
M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ D l M g/ Dl M g/ D l Gliclazid e
1 40M 341 419 260 340 199 301 145 1782cap sB.D. 80m g/ B.D
2 44M 306 386 208 269 188 208 108 1332cap sB.D. 80m g/ B.D
3 41M 290 370 190 250 112 140 79 962cap sB.D.
80M G / O D
4 45M 285 355 170 230 108 126 85 992cap sB.D.
80M G / O D
5 48F 310 365 215 290 171 200 110 1562cap sB.D. 80m g/ BD
6 55F 320 380 225 285 182 225 109 1292cap sB.D. 80m g/ B.D
7 54F 286 330 180 240 126 142 103 1342cap sB.D. 80m g/ O D
8 48M 330 410 265 332 173 290 111 1362cap sB.D. 80m g/ B.D
9 52M 322 385 256 310 166 275 98 1202cap sB.D.
80m g/ B.D
10 42F 260 325 156 236 98 123 66 1102cap sB.D.
80M G / O D

Second group of patients who were receiving herbal therapy only ,got the
normal blood glucose level but it took time longer duration than patients
consuming both herbal therapy and Glyclazide .Within first 15 days the blood
sugar decreased but not up to the normal range of (Fasting blood sugar ) 70-
110mg/Dl and Post Prandial blood sugar 90 -140 mg/Dl .Out of 10 patients in 7
patients the response was up to the good .

TABLE NO. 2 RESULT WITH IN ONE MONTH OF ONLY HERBAL THERAPY

P ATIEN TA GE SEX BLOO D GLUCOSE A FTER 15 DAYS 22DA YS(3W EEK)30DAYS DOSES OF M EDICIN E
N UM BER F.B.S. P .P.B.S.F.B.S. P.P.B.S F.B.S. P.P .B.S.F.B.S. P .P.B.S.HERBAL
M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl
1 42F 268 345 210 250 179 202 126 1672capsB.D.
2 45M 305 375 280 330 285 355 200 2602capsB.D.
3 43M 190 230 115 136 86 105 79 962capsB.D.
4 49M 220 265 170 230 129 158 103 1242capsB.D.
5 55M 258 325 205 230 171 200 115 1752capsB.D.
6 58F 210 280 160 204 118 130 96 1292capsB.D.
7 62F 176 205 168 198 126 142 105 1342capsB.D.
8 48M 196 278 130 167 100 140 99 1122capsB.D.
9 52M 290 370 210 270 137 176 98 1302capsB.D.
10 54F 285 315 255 290 205 245 125 1572capsB.D.

It took more than 1 month to get the glucose level up to the normal range.

The Control group or the patients who were supplied with the only sulfonylurea
group of medicine Glyclazide got their sugar level normal .Out of 10 patients 8
got their sugar level normal with in the period 30 days according to the severity
of the hyperglycemic condition. After the sugar level got to normal range the
dose reduced per day. The initial doses of medication was Glyclazide 80mg both
time a day

TABLE NO. 3 PATIENTS WITH THE STANDARD DRUG GLYCLAZIDE

P A TIENAT GE SEX BLO O D GLU COASEFTER 15 DA YS22DA YS(3W EEK30D ) A YS DO SES O F M EDICIN E
N UM BER F.B.S. P .P .B.S.F .B.S. P .P .B.SF.B.S. P .P .B.S.F .B.S. P .P .B.S.A LLO P A TH Y
M g/ D l M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl M g/ Dl Gliclazi de
1 44M 306 376 245 310 200 281 145 21080m g/ B.D
2 42F 267 320 196 259 176 255 143 19080m g/ B.D
3 56M 256 336 176 250 145 196 109 14280m g/ B.D
4 67M 246 316 170 230 108 126 82 9980m g/ B.D
5 45F 290 340 210 270 174 200 101 13080m g/ BD
6 56M 210 280 165 245 132 225 106 13280m g/ B.D
7 49F 190 269 108 185 86 142 67 9080m g/ O D
8 47F 230 310 155 225 112 290 86 11980m g/ B.D
9 53M 259 339 175 235 139 275 93 12280m g/ B.D
10 59M 180 225 136 186 88 123 69 8980M G/ O D

(B.D.).After the glucose level came down to normal state the doses reduced to
80mg once/Day.

Results and discussion

The comparative study of the herbal drug with the standard drug Glyclazide
shows that the herbal drug is effective at least in lowering the blood glucose
level up to normal range. No case of severe hypoglycemia has been found in
any of the patients. In case where both herbal drug and glyclazide
simultaneously used condition of hypoglycemia may arise .In case of high doses
of glyclazide may also cause severe hypoglycemia.

The herbal drug also caused no contra indicatory undesired effects like nausea
,vomiting, body rashes or belching dyspepsia etc.

Although the herbal drug took longer duration to get the blood glucose level to
normal state but still it is effective. The patients who were receiving the only
herbal therapy ,6 out of 10 patients got their glucose level normal in one month ,
2 out of 10 patients have got moderate result near to normoglycemic state.One
out of ten patients observed to be not so satisfactory result.