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CTRI Number  CTRI/2022/06/043618 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 17/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative effect of Narayana ghrita and Jeerakadhya ghrita on Hyperacidity 
Scientific Title of Study   A Randomised Comparative Clinical Study to evaluate the efficacy of Narayana Ghrita and Jeerakadhya Ghrita in the management of Urdhwaga Amlapitta with special reference to Dyspepsia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubhangini S Kolar 
Designation  MD PG Scholar Kayachikitsa 
Affiliation  BVVS Ayurved Medical College and hospital Bagalkot 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka India
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka India
Bagalkot
KARNATAKA
587 101
India 
Phone  7411499005  
Fax    
Email  shubhssk77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivaleela S Kalyani 
Designation  Professor and HOD 
Affiliation  BVVS ayurveda medical College and hospital Bagalkot 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka India
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka india
Bagalkot
KARNATAKA
587101
India 
Phone  9591273858  
Fax    
Email  drleelakalyani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhangini S Kolar 
Designation  MD PG Scholar Kayachikitsa 
Affiliation  BVVS ayurved medical College and hospital Bagalkot 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka india
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot 587101 karnataka India
Bagalkot
KARNATAKA
587 101
India 
Phone  7411499005  
Fax    
Email  shubhssk77@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurveda Medical College and Hospital,Bagalkot,Karnataka-587 101 
 
Primary Sponsor  
Name  BVVS Ayurveda Medical College and Hospital 
Address  BVVS Ayurveda 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 Shubhangini S Kolar  BVVS Ayurveda Medical College and Hospital Bagalkot  Kayachikitsa OPD and IPD BVVS Ayurveda Medical College and Hospital, BVVS CAMPUS, Bagalkot-587101
Bagalkot
KARNATAKA 
7411499005

shubhssk77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-for research on human subjects of BVVS Ayurved Medical College and Hospital ,Bagalkot,Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Narayana Ghrita, Reference: Bhaisajya Ratnavali,amlapitta chikitsa adhikara, Route: Oral, Dosage Form: Ghrita, Dose: 05(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -sukoshna jala), Additional Information: -total 10ml/day
2Comparator ArmDrugClassical(1) Medicine Name: Jeerakadhya Ghrita, Reference: Bharat Bhaisajya Ratnakar, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -sukoshna jala), Additional Information: -total 10ml/day
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients presenting with classical symptoms of Urdhwaga Amlapitta 
 
ExclusionCriteria 
Details  1)Patients with history of other chronic systemic illness
2)Established cases of Parinama shoola(gastric ulcer,duodenal ulcer),Annadrava shoola,Krimiroga and Arbuda
3)Pregnancy and Lactation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Notify improvement in symptoms like tiktaamlodgara,hrith-kanta daha,utklesh,chardi,
avipaka,gouravata 
15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief from the symptoms like tiktaamlodgara(bitter and sour belchings),hrith-kantha daha(Heart burn),utklesh(Nausea),Chardi(vomiting),avipaka(indigestion),gouravata(post-prandial fullness)  20 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   N/A 
Date of First Enrollment (India)   20/07/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

              Amlapitta is condition where Pitta is accumulated previously from the self aggravating causes, gets Vidagdha due to Virudha, Dustha, Amla, Vidahi, Pittakar Ahara and Drava like Phanita, Kulattha, Ikshu Vikara, Bhristha Dhanya, Pulaka etc. In further days due to repeated Nidanas it get Shuktatva residing in Aamashaya. Amlapitta has symptoms like Avipaka, Klama, Utklesh, Tiktaamlodgara, Gouravata, Hritkantha Daha, Aruchi etc1.              

         Urdhwaga Amlapitta can be correlated with Dyspepsia in modern science. Its symptoms are like nausea, indigestion , heart burn, sour and bitter belchings, post-prandial fulness etc2,3,4.

                 Prevalence rate of Dyspepsia in India is 30.4%. Most common symptoms included Abdominal fullness (24%), Abdominal pain (13.6%), Heart burn(10.7%) & Belching(10.6%)5   

        Dyspepsia affects the personal, mental, professional and economical status of individual life. Treatment modality includes administration of Proton pump inhibitors, H2-blockers and Antacids. Prolonged use of these drugs may cause loss of appetite, nausea, constipation etc6. So these drugs have restrictions of prolonged usage. Thus Ayurveda has scope for this treatment.                                                               

     In Ayurvedic classics, various therapies like Vamana, Virechana, Snehapana, Rakta Mokshana, Shamana Chikitsa and Rasayana etc are mentioned to manage Amlapitta. Ghrita is having unique quality of Sanskarasya Anuvartanaat, ability to imbibe the qualities of herbs by which it is being processed without loosing it’s basic qualities. In Amlapitta, Ghrita is mentioned as Pathya.7 Thus Ghrita is utilized as supreme media for drug administration. Ghrita is Vata-Pittahara, Na Shleshma Vardhana, Daha Shamaka and Agnideepana. hence it is used in the management of Amlapitta8                                                                                                           

Amlapitta is Pittapradhan and Saamavyadhi. Kledaka Kapha and Pachaka Pitta are Drava in dominancy. The Dravatah Vriddhi of Pitta reduces the Tikshanata of Pachaka Pitta as well as vitiates Kledaka Kapha leading to Agnimandya and unable to digest even little quantity of food. Narayan Ghrita contains ingredients like Pippali, Shunthi having properties like Katu Rasa, Tikshna Guna, Ushna Virya & Madhura Vipaka. Katuki is having Tikta Rasa, Shita Virya, and Katu Vipaka so used in Vikruta Pitta and Kaphajanya Vikaras. It does Deepana, Pachana, Rochana and Dosha Samshodhan. Due to Madhura Guna of Pippali it acts as Pittashamaka and due to Ushnata, Madhura Vipaka Vatanulomana takes place. Guduchi, Amalaki, Draksha does the Shamana of Udrikta Pitta. Ghrita is having Madhura Rasa, Madhura Vipaka, Sheeta Veerya, Pitta-Anilahara, it is having Agnideepaka Tridoshahara property. By these properties it does the Samprapti Vighatana on Amlapitta. Jeerakadhya Ghrita contains Jeeraka which is Agnideepaka & Dhanyaka which is Pittashamak. By considering above qualities drugs are selected for the study of management of Urdwaga Amlapitta.

 
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