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CTRI Number  CTRI/2019/08/020958 [Registered on: 29/08/2019] Trial Registered Prospectively
Last Modified On: 28/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Ayurveda medicine in AMLAPITTA 
Scientific Title of Study   A CLINICAL AND COMPARATIVE STUDY OF PIPPALI GHRIT AND PITTANTAK YOG ON AMLAPITTA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Kedar Lal Meena 
Designation  Prof. and HOD department of Maulik Siddhant 
Affiliation  National Institute of Ayurveda 
Address  P G Department Maulik Siddhant National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414638857  
Fax    
Email  drkedar01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Kedar Lal Meena 
Designation  Prof. and HOD department of Maulik Siddhant 
Affiliation  National Institute of Ayurveda 
Address  P G Department Maulik Siddhant National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414638857  
Fax    
Email  drkedar01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahendra Kaswan 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  P G Department Maulik Siddhant National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9352763122  
Fax    
Email  kaswanmahendra@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav vilas palace, Amer road, Jaipur (PIN - 302002) 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 
Type of Sponsor  Research institution and hospital 
 
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 Mahendra Kaswan  National Institute of Ayurveda, Jaipur  OPD No.21, P.G. Department of Maulik Siddhant and Samhita, National Istitute of Ayurved (Madhav Vilas Palace), Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (Rajasthan
Jaipur
RAJASTHAN 
9352763122

kaswanmahendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K273||Acute peptic ulcer, site unspecified, without hemorrhage or perforation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pippali Ghrit  Pippali Ghrit 10 ml before meal with madhu twice a day for one month 
Intervention  Pittantak Yog  Pittantak Yog 1 gm before meal twice a day with water for one month 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient between 16years to 60years.
2.Patients of classical Amlapitta symptoms, irrespective of gender, caste, occupation and economic status.
3.Amlapitta of any dosha anubandha (associated doshah).
 
 
ExclusionCriteria 
Details  1.Patient below 16 and above 60 years of age.
2.Patients with complication of acute or chronic gastritis like peptic ulcer any secondary infections or syndromes and medical emergencies.
3.Pregnant women or lactating mothers.
4.Any other systemic disorder than amlapitta.
5.Patient along with diabetes, HTN,COPD, Malignancy.
6.Complication which intervenes the course of treatment.
7.Patient on chemo and radiotherapy for malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms of Amlapitta.  baseline, 15 days, 30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Measurement of Amlapitta (Acidity) severity.  baseline, 15 days, 30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/09/2019 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Amlapitta is a clinical condition which has become a common problem for most of the people in this modern era. Due to changed life style, increased pace of life, stress as well as changes in food habits. The prevalence rate of gastritis in india is around 10 millions. The risk  factors like spicy food ,alcohol,aspirin,other NSAID’s ,or any gastric mucosa by inhibiting prostaglandins, gastric bi-carbonates and mucous secretions and alters the mucosal micro circulation.

      This produces symptom like heart burn, sour belching, acid eructation, anorexia and nausea. This leads to acute gastritis and if left unattended in the chronic stage it leads to gastric or duodenal ulcers, followed by perforation if untreated. The remedies in biomedicine are acid suppressive agents like H2 receptors antagonists, proton- pump inhibiters etc. These are working temporarily without any permanent solution as well as having adverse effects after long standing usage. Hence we shall consider the chikista sutra kaphapittahara vidhi described by Yogaratnakar to overcome the disease and the selected drug is the Pippali ghrit  described by Chakradatta to overcome the disease and the selected drug Pippali ghrit containing pippali kawath, pippali kalak and gou ghrit and Pittantak yog containing Sitopala, Amrit dhara, Sudh Savaran gairik having seetvirya, madhura rasa and pittasamaka and agnidipaka guna.

 
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