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MATERIALS AND METHODS:
q Study
design:
Double Blind Randomized
Control Clinical Trial.
q Clinical
Data
A newly diagnosed cases of Urdhwaga Amlapitta
will be randomly selected from Opd/Ipd of department of Kayachikitsa of KLEU Ayurveda
Hospital and research Center Shahapur Belagavi.
Vasa Guggulu
:
Will
be prepared in the KLEU’S GMP certified
Ayurveda Pharmacy, Khasbag, Belagavi.
SootasekharaRasa:
Will be procured from KLEU GMP certified Ayurveda Pharmacy,Khasbag,Belagavi.
q Literary Data:
a)
Library b) Relevant research article c) Relevant internet related articles.
q SUBJECTS:
q Clinical Data
Newly diagnosed cases of UrdhwagaAmlapitta
attending opd/ipd of Kayachikitsa department, KLEU Ayurveda hospital Shahapur Belgavi,
fulfilling the inclusion criteria will be enrolled into the study and randomly
assigned into two groups i.e. Group A and Group B.
q Authentication-
Raw drugs will be authentified in the AYUSH approved
drug laboratory for ASU drugs,Govt of India, K.L.E University Shri B.M.K.
Kankanwadi Ayurveda Mahavidyalaya,Belagavi.
q Preparation-
VasaGuggulu will be prepared as per SOP of KLEU’S GMP certified Ayurveda
Pharmacy,Khasbag,Belagavi.
q Analysis-
Both raw drug and final product analysis will be
done at AYUSH approved central research facility of K.L.E University Shri .B.M.K. KankanwadiAyurveda Mahavidyalaya,
Belagavi.
q Sample
Size : 40
q Diagnostic
Criteria:
o
Avipaka
o Klama
o Tiktaamlaudgaara
o Hrut –kanthadaha
q Inclusion
criteria:
1.
Patient between age group of 20 to 60yrs
2.
A newly diagnosed case of Urdhwaga Amlapitta
presenting with Avipak,Klama, Tikta-amlaudgaar,Hrit-kanthadaha.
3.
Irrespective of sex,religion and socio-economic
status.
q Exclusion
criteria:
1.
Patients those who are on NSAID
2.
Patients suffering from other systemic illness such
as Grahani, Parinamashula,Annadravashulaetc.
3.
Patients on antacids
- Pregnant women.
5.
Lactating
women
GROUP&
INTERVENTION INCLUDING FOLLOW UP
|
GROUP
|
SAMPLE SIZE
|
INTERVENTION
(0th
-30th day)
|
DOSE
|
FOLLOW UP
|
|
A
|
20
|
Vasa guggulu
|
500mg
|
15th day
30th day
|
|
B
|
20
|
Sootsekhar rasa
|
250 mg
|
15th day
30th day
|
q SOPs
if any:
Not
applicable.
q ASSESSMENT
CRITERIA9 :
AVIPAKA
|
Grades
|
Characteristics
|
|
G0
|
No digestion
|
|
G1
|
Digests normal usual diet
in 9 hours
|
|
G2
|
Digests normal usual diet
in 12 hours
|
|
G3
|
Digests normal usual diet
in 24 hours or more
|
KLAMA
|
Grades
|
Characteristics
|
|
G0
|
No tiredness
|
|
G1
|
Feel tired after exertional
work
|
|
G2
|
Feel tired after normal
work
|
|
G3
|
Feel tired even after
taking rest
|
TIKTA-AMLA
UDGAAR
|
G0
|
No sour and bitter
belching
|
|
G1
|
Sour and bitter belching
after taking spicy food
|
|
G2
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Sour and bitter belching
after taking any type of food
|
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G3
|
Sour and bitter belching
having no relation with food
|
HRIT-KANTHA DAHA
|
G0
|
No burning sensation
|
|
G1
|
Burning sensation after
intake of spicy food
|
|
G2
|
Feeling of burning
sensation even after intake of normal food
|
|
G3
|
Burning sensation on empty
stomach
|
q Parametric:
Not
applicable
q Non
parametric:
Avipaka,Klama,
Tikta-amlaudgaar,Hritkantadaha
q Duration
required for completing the Study:
18 month.
q Statistical
Methods to analyse the data:
Analysis will be done as per applicable test.
q Expected
Outcomes:
Group treated with Vasa
Guggulu may have better efficacy than group treated with Sootsekhar Rasa.
q Withdrawal
Criteria:
Subjects participating in clinical trial will be
withdrawn if there is appearance of either any serious complication or ADR
q Rescue
Medication:
Minor complication and ADR will be managed in our
hospital with appropriate measures. Major complications will be referred to
tertiary care centre.
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