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CTRI Number  CTRI/2025/03/082140 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study conducted to see the Effect of Patolashunti ghrita and Jeerakadya ghrita in the Management of Urdhwaga Amlapitta With special refernce to Dyspepsia 
Scientific Title of Study   A Randomized Comparative Clinical Study To evaluate the effect of Patolashunti Ghrita and Jeerakadya ghrita in the management of Urdhwaga Amlapitta with special reference to Dyspepsia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR .Kavya S 
Designation  PG Scholar Kayachikitsa 
Affiliation  BVVS Ayurved Medical College and Hospital  
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical college and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9902659275  
Fax    
Email  kavyas199802@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunilkumar M Chabanur 
Designation  Associate Professor 
Affiliation  BVVS Ayurved Medical College and Hospital ,Bagalkot,Karnataka 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical college and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  09740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunilkumar M Chabanur 
Designation  Associate Professor 
Affiliation  BVVS Ayurved Medical College and Hospital ,Bagalkot,Karnataka 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical college and Hospital BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  09740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital,India,Bagalkot,Karnataka-587101 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot, Karnataka-587101 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Kavya S  BVVS Ayurved Medical College and Hospital  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical college and Hospital BVVS Campus Bagalkot
Bagalkot
KARNATAKA 
09740878703

drsunilkumar09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBVVSAYURVEDMEDICALCOLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patola shunti ghrita, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Jeerakadya ghrita, Reference: Bharat Bhaisajya Ratnakar, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patient Presenting With Classical Symptoms of Urdhwaga Amlapitta.
2.Patient between age group 20-50 
 
ExclusionCriteria 
Details  1.Patient With Uncontrolled DM,HTN.
2.Patient Diagnosed With Peptic Ulcer,Duodenal Ulcer,IBS and Who Had Chronicity more than 5 years. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the effect of Patolashunthi ghrita and Jeerakadya Ghrita in the management of Urdhwaga Amlapitta with special reference to Dyspepsia  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Aims and Objectives of the study
1. To compare the effect of patolashunthi ghrita and jeerakadhya ghrita in the management of urdhwaga amlapitta with special reference to dyspepsia.
2. To evaluate effect of patolashunthi ghrita in the management of urdhwaga amlapitta with special reference to dyspepsia.
3. To evaulate the effect of jeerakadhya ghrita in the management of urdhwaga amlapitta with special reference to dyspepsia 
15 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary            Amlapitta is one of the most prevalent diseases in the modren era as a result of changing lifestyle,dietary preference and individualbodily constitutions pitta becomes more aggravated especially in its drava and amla characteristics which results in Amlapitta.
         Amlapitta is a diseases of Annavaha srotas ,caused by vitiation of Agni,it is a condition where pitta is accumulated previously from the self aggravating causes gets vidagdha due to virudda,dushta,Amla,Vidahi,Pittakara ahara and Drava like Phanita,Kulatta,Brishta dhanya,Pulaka etc are the primary causes of the disease.Amlapittta has symptoms like Avipaka,Klama,Utklesha,Tikta amlodgara,gourava,Hrut-kanta daha,Aruchi.
        It is a pitta pradhana vyadhi where Drava and Amla guna of pachaka pitta are increases,The Dravatavriddi of pitta reduces tikshnata of pachaka pitta as well as vitiates kledaka kapha leading to Agnimandya.Thus even little quantity food also not properly digested.
        Urdhwaga Amlapitta can be correlated with dyspepsisa with similar clinical presentations.Its symptoms are like sour-bitter bleching,Heart burn,Nausea,Vomiting, Indigestion,Post prandial fullness..
The worldwide prevalence rate of dyspepsia is 20 -30%.It is slightly higher in western population.While the precise prevalence of dyspepsia in India is not Available. Different studies estimate that it affects 7.6-49% of Indian population.
        Treatment modalities includes administration of Proton pump inhibitors ,H2 Blockers and Antacids prolong use of these medication cause Nausea,Constipation,Loss of appetite,Stomach ach ,Osteoporosis.
        In Ayurveda classics various therapies like Vamana,Virechana,Snehapana,Shamana and Rasayana have been mentioned.Nidana parivarjana ,Amapachana,Agnideepana are the main goals of the Amlapitta treatment.If this diseases not properly treated it may give various comlications in our body like Jwara,Pandu,Shotha ,bhrama.
        Jeerakadya Ghrita is mentioned in Bharata Bhaishajya Ratnakara,Amlapitta chikitsa.It contains ingredients like jeeraka ,dhanayaka,and goghrita.Jeeraka has properties like katu,rasa,laghu-ruksha guna,Ushna virya,katu vipaka which helps in Agnideepana and Amapachana.Dhanyaka has properties like kashaya tikta rasa,snigdha guna,ushna virya,Madhura vipaka which help in Agnideepana,Amapachana,dahapnashamana and Pittashamana.
        Patola Shunti Ghrita mentioned in Bhaishajya Ratnavali, Amlapitta chikitsa Adhyaya,It contains ingredients like Patola,Shunti,Gogrita.Patola has properties like Tikta katu rasa,laghu-ruksha guna,Ushna virya,Katu vipaka.
Shunti has properties Katu rasa,Tikshna guna,Ushna virya,Madhura vipaka.Ghrita has properties like Guru-snigdha guna,Madhura rasa,and Madhura vipaka,Sheeta virya,it acts as Pitta shamaka. due to Teekshna guna it does Shodana.Tikta katu rasa has Vayu and Akasha mahabutha which dries up the Dravata Vriddi of pitta and removes Srotorodha.Katu vipaka helps in Kapha shamaka,Madhura vipaka helps in Vata pitta Shamaka,due to Madhura rasa it helps in Dahaprashamana and Pitta shamaka by these properties Patola Shunti Ghrita may in help in samprapti vighatana of Amlapitta.Hence present study will be aimed to evaluate and compare the effect of Patola Shunti Ghrita and Jeerakadya ghrita in Urdhwaga Amlpapitta (Dyspepsia).

 
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