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CTRI Number  CTRI/2022/03/041547 [Registered on: 31/03/2022] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   -Study of Causes of Amlapitta and correlation with Prakruti  
Scientific Title of Study   -“An Observational Study of Etiopathological factors of Urdhvag Amlapitta with special reference to Deh Prakruti  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Drvedashri AKalavade 
Designation  Professor 
Affiliation  Dr.D.Y.Patil Ayurved Medical College,Pune 
Address  Hon.ADAMC,Ashta, Rognidan Dept.Ashta. Sangli.Maharashtra.
Dr.D.Y.Patil Ayurved Medical College,Pune. Sant Tukaram Nagar,Pimpari Chinchwad Pune
Kolhapur
MAHARASHTRA
416115
India 
Phone  9890091480  
Fax    
Email  veashri22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prakash Mane 
Designation  Professor 
Affiliation  Dr.D.Y.Patil Ayurved Medical College,Pune 
Address  Dr.D.Y.Patil Ayurved Medical College,Pune. Rognidan Dept. Sant Tukaram Nagar, Pimpari Chinchwad,Pune

Kolhapur
MAHARASHTRA
411018
India 
Phone  9423277615  
Fax    
Email  maneprakash1171@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Drvedashri AKalavade 
Designation  Professor 
Affiliation  Dr.D.Y.Patil Ayurved Medical College,Pune 
Address  Hon.ADAMC,Ashta, A/P Ashta Rognidan Dept. Ashta Sangli.
DR.D.Y.Patil Ayurved Medical College,Pune
Kolhapur
MAHARASHTRA
416116
India 
Phone  9890091480  
Fax    
Email  veashri22@gmail.com  
 
Source of Monetary or Material Support  
Dhanvantari Rugnalay,Hon.ADAMC,Ashta 
 
Primary Sponsor  
Name  Dr DYPatil College of AyurvedPune  
Address  Dr D.Y.Patil College of Ayurved,Sant Tukaram Nagar, Pimpari Chichwad ,Pune  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vedashri kalawade  Dr DY.Patil college of ayurved  Dr.D.Y.Patil Ayurved College,Pune .Sant Tukram Nagar,Pimpari Chinchwad,Pune.Rognidan Dept
Pune
MAHARASHTRA 
9890091480

vedashri22@gmail.com 
Dr Vedashri Kalavade  Hon Shree Annasaheb Dange Ayurved Medical college ashta  Hon Shree Annasaheb Dange Ayurved Medical college Ashta, Dhanvantary Hospital.Kayachikitsa OPD
Sangli
MAHARASHTRA 
9890091480

vedashri22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dr.D.Y.Patil college of Ayurved   Approved 
Hon Shree Annasaheb Dange Ayurved Medical college ashta  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   1)Patients will be selected of both sexes
 2) Patients of age groups 16-60 years.
 3) Patients suffering from signs and symptoms of urdhvag Amlapitta will be selected for the study.

 
 
ExclusionCriteria 
Details  ) Known patients of peptic ulcers and gastritis.
2) Known patients of malignancy of G.I.T.
3) Patients of any other systemic diseases.
4) Patient having fever more than 100 Fahrenheit will be excluded from study.
5) Patients with endocrine disorder

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect bof etiological factors on Amlapitta  Observational -4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Causetive factors will be assessed and listed .Also Prakruti of the patient will be decided.
Outcome will be confirmation of causes and Prakruti of the patient and relation in manifestation of the disease. 
observational-4 weeks  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2022 
Date of Study Completion (India) 13/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Observational study of causative factors of Amlapitta studied.With the help of questionnaire hetus were studied.By stastical analysis hetus of the disease was confirmed .
Also Prakruti of the patient  studied and relation of the prakruti in the development of the disease will be decided.
This will help the patient for the prevention of the disease .As amlapitta has no any complete cure available.So prevention of the cause is necessary to avoid complicationsThe clinical data analysis on Urdhvag Amlapitta reveals significant insights into its demographic and etiological patterns. The highest incidence (35%) was observed in patients aged 17-26, likely due to heightened Pitta activity during this period. Gender distribution showed a predominance of females (59%), which may be attributed to hormonal influences on Pitta and Kapha doshas, while males were more affected by dietary habits, stress, and alcohol, which primarily aggravated Pitta and Vata doshas.Weight distribution indicated that individuals weighing 50-59 kg (Pitta-dominant) were notably affected, as stress and dietary choices exacerbated acid production. In contrast, Kapha- dominant individuals (70-80 kg) experienced symptoms due to slow digestion and increased abdominal pressure. Most patients were of Pitta-Vata Prakruti (40%), highlighting the need for personalized treatment strategies focusing on stress management and dietary discipline.Dietary factors like Viruddhashan (incompatible foods) and Adhyashan (overeating) were significant contributors to symptom severity, especially in Pitta-Kapha individuals. Heavy, cold, and sticky foods, as well as excessive fluid intake during meals, also aggravated symptoms. Psychological factors, particularly stress, anger, and grief, were prevalent and further exacerbated the condition.The study underscores the critical role of both primary and secondary hetus (causes) in managing Urdhvag Amlapitta. It emphasizes the importance of addressing immediate dietary and lifestyle factors, as well as underlying health issues, to develop effective, personalized treatment plans. The findings affirm the alternate hypothesis, showing a significant correlation between etiological factors and the manifestation of Urdhvag Amlapitta.
 
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