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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 | 2 | Comparator Arm | Drug | Classical | | (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. |