randomized double blind clinical trials of
two different samples of Bhallataka Kshaudra
will be carried out on the patients of Madhumeha
(NIDDM) very cautiously as per classics.
Plan of study:
Criteria for selection of patients:
Patients having classical symptomatology of Madhumeha (NIDDM) will be selected from
O.P.D. and I.P.D. of I.P.G.T. and R.A., Hospital, Jamnagar.
·
Age group of patients will be between 18 to 75
years.
·
Patients having fasting blood sugar level≥126mg/dl
or 2hrs.
·
Post prandial glucose level≥200mg/dl up to 600mg/dl
will be selected from O.P.D and I.P.D of I.P.G.T. and R.A., Hospital, Jamnagar.
Criteria for exclusion of Patients:
(A) Patients of Diabetes mellitus receiving Insulin.
(B) Patients having chronic complications of
Diabetes mellitus
a. Microvascular:
Retinopathy, Neuropathy and Nephropathy.
b. Macrovascular:
Coronary artery disease, Peripheral vascular disease & Cerebro-vascular
disease.
c. Other chronic
debilitating disease like STD etc.
(C) Pitta-Adhikya,
Garbhini, Vimukta Raktatva, Trisna, Mukha Shosha, Anatamvana, Aalsi, Pramadi,
Vyasani, Bhesajapmani.
Criteria for diagnosis of Diabetes mellitus (NIDDM)
·
Symptoms of Diabetes (Polyuria, Polydipsia &
Polyphagia and weight loss)
·
Fasting Plasma glucose ≥126mg/dl.
·
Two hour Plasma glucose ≥200mg/dl during an oral
glucose tolerance test.
A detailed proforma will be prepared, also
with detailed history will be taken and complete physical examination will be
carried out to assertion the diagnosis. Laboratory investigations like plasma
glucose level, s-cholesterol, Heamatological (Hb, TLC, DLC, ESR), Urine
(routine, microscopic), Biochemical (BSL, LFT, RFT, Lipid profile,
s-creatinine) and if needed special investigations like plasma Insulin, Glycosylated
Haemoglobin etc. will also be carried out as per availability.
Groups:
Selected patients will be divided into two groups –
(1)
Group A – In this group,
patients will be treated with drug prepared with Yava Rashi Nidhapita Bhallataka.
(2)
Group B – In this group,
patients will be treated with drug prepared with Yava Rashi Anidhapita
Bhallataka.
Posology;
Dose :
500 mg in divided dose in
both the groups.
Duration : 4 weeks
Follow up : Patients will be reviewed after 7 days for a period
of 4 weeks.
Assessment of overall effect of the therapy: For
the assessment of the effect of the therapy following criteria will be used –
(1)
Improvement of the signs and symptoms of the disease as
per Ayurvedic and Modern classics.
(2)
All the required investigations will be conducted
before and after the management of the patient.
(3)
A scoring pattern will be used – 100 points will be
divided as follows:
·
Subjective criteria – 50 points
·
Objective criteria – BSL-F –
25 points
– BSL-PP – 25 points
Scoring for biochemical parameters; Blood sugar level –
80%
to 90% Improvement –
25 points
60%
to 80% Improvement –
20 points
40%
to 60% Improvement –
15 points
20%
to 40% Improvement –
10 points
<20% Improvement –
05 points
No Improvement – 00 points
(4)
The
result obtained from individual patients will be categorized as –
·
Control of the disease – 100% relief
·
Marked improvement -
≥75% relief
·
Moderate improvement – 50% upto 75% relief
·
Mild improvement -
≥25% upto 50% relief
·
No improvement -
<25% relief
Statistical analysis:
Mean, percentage relief, SD, SE, ‘t’
and ‘p’ values will be calculated. Paired ‘t’ test will be used for calculating
the ‘t’ value in the paired data. For comparison of the results with normal
control group, unpaired ‘t’ test will be used. For comparison of results in
objective parameters, “Analysis of Variance Test (ANOVA)†will be applied. |