Effect of vasa guggulu in Acidity
- Conditions
- A newly diagnosed case of Urdhwaga Amlapitta presenting with Avipak,Klama, Tikta-amlaudgaar,Hrit-kanthadaha.
- Registration Number
- CTRI/2018/01/011416
- Lead Sponsor
- KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYASHAHAPURBELGAVI
- 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
4. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
A newly diagnosed case of Urdhwaga Amlapitta presenting with Avipak,Klama, Tikta-amlaudgaar,Hrit-kanthadaha.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Group treated with Vasa Guggulu has better efficacy than group treated with Sootsekhar Rasa. 30 DAYS
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
KLEUS Shri BMK Ayurvedic Mmahavidyalaya
🇮🇳Belgaum, KARNATAKA, India
KLEUS Shri BMK Ayurvedic Mmahavidyalaya🇮🇳Belgaum, KARNATAKA, IndiaDR SUJITSINH MOHITEPrincipal investigator9403259795drsujitmohite1590@gmail.com