INTRODUCTION: Diabetes mellitus is a chronic disease
caused by inherited and/or acquired deficiency in production of insulin by the
pancreas, or by the ineffectiveness of the insulin produced. Such a deficiency
results in increased concentrations of glucose in the blood, which in turn
damage many of the body’s systems, in particular the blood vessels and nerves. The diseases afflicting urine are classified into
two types Mutra Apravrittaja Rogas
i.e. diseases leading to less quantity of urine and Mutratipravrittaja Rogas i.e. diseases leading to excess quantity
of urine, Prameha being Mutratipravrittaja roga. Prameha as the
word says, “prakarshena prabhutam
prachuram varam varam va mehatiâ€. It is further subdivided into
20, based on physical abnormalities of urine. However, all Prameha if neglected may lead to Madhumeha in long term. Madhumeha has been extensively described in
ancient ayurvedic texts of all times
including brihadtrayi and laghutrayi. Acharya
Charaka is very specific while
describing the types of Prameha on the basis of onset as Sahaja / Jatah
Prameha and Apathyanimittaja prameha.
AIMS and OBJECTIVES
AIMS:
To provide DMT2 patients with the
possibilities of
(i)
Reduction in BSL
(ii) Improving quality of life in DMT2 patients.
OBJECTIVES:
The objectives of conducting this
study are:
PRIMARY OBJECTIVES:
To determine the efficacy of yakrit-uttejaka rohitakadi churna along with triphaladi granules over that of triphaladi granules alone in the management of madhumeha by estimating the levels of FBS,
PPBS, HbA1C.
SECONDARY OBJECTIVES:
1. To determine the Quality of Life in
DMT2
2. To evaluate the pharmacognostical potency
of the trial drug
3. To evaluate in terms of Ayurveda
parameters, such as roga bala, agni
bala, deha bala, chetas bala
and mutra pariksha.
4. To
determine the Urine sugar concentration by
colorimetric assessment
EXECUTION
OF THE PROPOSED CLINICAL STUDY
TYPE OF STUDY DESIGN: Randomised Comparative
Clinical Trial
SETTING: The OPDs’ and IPD’s of AIIA
RESEARCH DESIGN: Interventional
study
ALLIGNMENT: Parallel
SAMPLE: population- Patients from institutional
hospital
SAMPLING METHOD: Computer generated table
MASKING: open label
SAMPLE CLASSIFICATION:
Group A: Triphaladi granules
Group B : Triphaladi granules + Rohitakadi churna
POSOLOGY:
|
|
Group A
|
Group B
|
|
Drug
|
Triphaladi
granules
|
Triphaladi
granules + Rohitakadi churna
|
|
Form
|
Powder
|
Powder
|
|
Dose
|
5gm morning
after breakfast and night before meal daily
|
5gm each
morning after breakfast and night before meal daily
|
|
Mode of administration
|
Oral
|
Oral
|
|
Anupaan
|
Plain water
|
Plain water
|
|
Duration
|
3 months
|
3 months
|
DIET AND EXERCISE (COMMON TO BOTH
GROUPS) :
In Ayurvedic treatment, the main
treatment regime includes drug intake along with the pathya-apathya in ahara-vihara
and physical activities.
The patients would be advised to
follow particular diet and exercises explained to them in detailed proformas.
DURATION OF THE TRIAL: 3 MONTHS with a follow up period
of 1 month
Detail Timeline of the Proposed Research
Project are listed in annexure
MONITORING
PERIOD 0 – 3M:
Patients are told to report weekly
for 1st 2 weeks and then fortnightly during the period of next three
months. At the end of monitoring period, the drugs will be withdrawn.
FOLLOW
UP PERIOD: 3M-4M
Patients are informed to report
after 1 month of completion of clinical trial (window period of 7 days)