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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ï½ 1)Patients will be selected of both sexes
ï½ 2) Patients of age groups 16-60 years.
ï½ 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. |