Effect of Vasa Guggulu in the management of Urdhwaga Amlapitta-A randomised double-blind control clinical trial
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Group treated with Vasa Guggulu has better efficacy than group treated with Sootsekhar Rasa.
Study Overview
Brief Summary
MATERIALS AND METHODS:
q Studydesign:
Double Blind RandomizedControl Clinical Trial.
q ClinicalData
A newly diagnosed cases of Urdhwaga Amlapittawill be randomly selected from Opd/Ipd of department of Kayachikitsa of KLEU AyurvedaHospital and research Center Shahapur Belagavi.
Vasa Guggulu:
Willbe prepared in the KLEU’S GMP certifiedAyurveda 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 UrdhwagaAmlapittaattending opd/ipd of Kayachikitsa department, KLEU Ayurveda hospital Shahapur Belgavi,fulfilling the inclusion criteria will be enrolled into the study and randomlyassigned into two groups i.e. Group A and Group B.
q Authentication-
Raw drugs will be authentified in the AYUSH approveddrug 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 bedone at AYUSH approved central research facility of K.L.E University Shri .B.M.K. KankanwadiAyurveda Mahavidyalaya,Belagavi.
q SampleSize : 40
q DiagnosticCriteria:
o Avipaka
o Klama
o Tiktaamlaudgaara
o Hrut –kanthadaha
q Inclusioncriteria:
1. Patient between age group of 20 to 60yrs
2. A newly diagnosed case of Urdhwaga Amlapittapresenting with Avipak,Klama, Tikta-amlaudgaar,Hrit-kanthadaha.
3. Irrespective of sex,religion and socio-economicstatus.
q Exclusioncriteria:
**1.**Patients those who are on NSAID
**2.**Patients suffering from other systemic illness suchas Grahani, Parinamashula,Annadravashulaetc.
**3.**Patients on antacids
- Pregnant women.
**5.**Lactatingwomen
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 SOPsif any:
Notapplicable**.**
q ASSESSMENTCRITERIA9 :
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-AMLAUDGAAR
| G0 |
No sour and bitter belching
|G1
Sour and bitter belching after taking spicy food
|G2
Sour and bitter belching after taking any type of food
|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:
Notapplicable
q Nonparametric:
Avipaka,Klama,Tikta-amlaudgaar,Hritkantadaha
q Durationrequired for completing the Study:
18 month.
q StatisticalMethods to analyse the data:
Analysis will be done as per applicable test.
q ExpectedOutcomes:
Group treated with VasaGuggulu may have better efficacy than group treated with Sootsekhar Rasa.
q WithdrawalCriteria:
Subjects participating in clinical trial will bewithdrawn if there is appearance of either any serious complication or ADR
q RescueMedication:
Minor complication and ADR will be managed in ourhospital with appropriate measures. Major complications will be referred totertiary care centre.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •A newly diagnosed case of Urdhwaga Amlapitta presenting with Avipak,Klama, Tikta-amlaudgaar,Hrit-kanthadaha.
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 4.Pregnant women.
- •5.Lactating women.
Outcomes
Primary Outcomes
Group treated with Vasa Guggulu has better efficacy than group treated with Sootsekhar Rasa.
Time Frame: 30 DAYS
Secondary Outcomes
No secondary outcomes reported