FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041772 [Registered on: 11/04/2022] Trial Registered Prospectively
Last Modified On: 16/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   An Observational Study 
Study Design  Other 
Public Title of Study   An observational study on Pramana Sharira and its relation with prognosis of chronic kidney disease(stage-5) 
Scientific Title of Study   An observational study on Pramana Sharira with special reference to Vishama Ayama-Vistara and its relation with prognosis of chronic kidney disease(stage-5) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mital D Kanani 
Designation  PG Scholar 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Post Graduate Department of Rachana Sharira, J. S. Ayurveda Mahavidyalaya, College road, Nadiad.

Kheda
GUJARAT
387001
India 
Phone  8758072340  
Fax    
Email  mitalkanani11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seetharama Mithanthaya 
Designation  Professor 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Post Graduate Department of Rachana Sharira, J. S. Ayurveda Mahavidyalaya, College road, Nadiad.

Kheda
GUJARAT
387001
India 
Phone  9901732256  
Fax    
Email  drsitharam1@gmai.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seetharama Mithanthaya 
Designation  Professor 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Post Graduate Department of Rachana Sharira, J. S. Ayurveda Mahavidyalaya, College road, Nadiad.

Kheda
GUJARAT
387001
India 
Phone  9901732256  
Fax    
Email  drsitharam1@gmai.com  
 
Source of Monetary or Material Support  
J. S. Ayurveda Mahavidyalaya & P. D. Patel Ayurveda Hospital, Nadiad. 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  J S Ayurveda Mahavidyalaya, College road, Nadiad 
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 Mital D Kanani  P. D. Patel Ayurveda Hospital, Nadiad  Post graduate depertment of Rachana Sharira, J. S. Ayurveda Mahavidyalaya and P. D. patel Ayurveda hospital, College road, Nadiad.
Kheda
GUJARAT 
8758072340

mitalkanani11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N185||Chronic kidney disease, stage 5. Ayurveda Condition: Chronic Kidney Disease (stage-5),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Already diagnosed patients of chronic kidney disease (stage-5) with bad prognosis.
(Those who have <15 ml/min eGFR or those who are under dialysis will be considered
as bad prognosis)
2. Individuals of either sex between 30-60 years. 
 
ExclusionCriteria 
Details  1. Individuals with accidental or traumatic cause.
2. Individuals with the history of fracture of long bone.
3.Individuals who had undergone amputation of limb.
4. Individuals with the deformity in vertebral column.
5. Any visible structural abnormalities. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Proposed research work will help the physicians to predict the possible bad prognosis at a very early stage of the chronic kidney disease by measuring the Ayama-Vistara of the patient.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2022 
Date of Study Completion (India) 11/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Dr. Mital Dilipbhai Kanani,Prof. Dr. Seetharama Mithanthaya,Prof. Dr. Kalapi Patel, Dr. Vidhi Parmar. Title: Application of Pramana Pariksha w.s.r. to Purusha Ayama-Vistara as a prognostic tool in the evaluation of prognosis of chronic kidney disease - A retrospective study. Journal: Souvenir of 7th International Conference on practical application of fundamental & diagnostic principles of Ayurveda organized by J. S. Ayurveda Mahavidyalaya, Nadiad, Gujarat. Month of publication: September-2023 Page no.: 97-104 ISBN Number: 978-93-91261-94-8 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
  • SUMMARY

    The study entitled, “An observational study on Pramana Sharira with special reference to Vishama Ayama-Vistara and its relation with prognosis of chronic kidney disease (stage-5)” comprises of 6 chapters namely introduction, aim and objectives, review of literature, observational study, discussion and interpretation & conclusion and summary.

    Chapter 1: Introduction

    It gives compact idea of the subject of discussion namely Pramana Sharira. The Relevance of this topic especially based on its clinical importance, which was also highlighted.

    Chapter 2: Aim and objectives

    It gives an idea about aim & objectives of the study.

    Chapter 3: Review of literature

    Review of literature is sub-divided into historical review, previous research work, review of Pramana Sharira, review of anthropometry & review of CKD – Ayurveda and modern perspective. Historical review consists of references pertaining to Pramana in various ancient literatures of Vedic period, Samhita period and Sangraha Kala followed by a table with the information regarding previous research work. Review of Pramana Sharira, elaborates the details & importance of Pramana in various ancient ayurvedic texts, it also detailed regarding available references related to Anguli Pramana. Review of anthropometry deals with details of anthropometry and its utility. Ayurveda and modern perspective of CKD explained in the last part of this chapter.

    Chapter-4: Observational study

    Detail methodology of the present study was given in this chapter along with inclusion and exclusion criteria. Afterwards observations and results of 50 individuals of CKD (stage-5) were put forth by the tabular and graphical presentation.

    Chapter 5: Discussion and interpretation

    It is subdivided into discussion on review of literature, discussion on methodology, discussion on observation and results. It comprises the details of the analyzed data and comparison with the basic concept mentioned in the ancient literature & contemporary science, also dealt with the relevance in this era.

    Chapter 6: Conclusion and summary

    Summarizes the entire research work and it consists of conclusion drawn from the work carried out along with further scope of research.

  • CONCLUSION

    Pramana is a crucial parameter among the Dashavidha Pareekshyabhava outlined in Charaka Samhita. As described in the Rogabhishagjitiyam Vijnanam, there exists a sutra that delves into the concept of “Sama Ayama-Vistara”, and its direct correlation with a healthy and happy life. This historical wisdom underpins the present study, which retrospectively explores Ayama-Vistara disparities in CKD individuals.

    §  The eGFR values, ranging from 3.7 to 13.96 ml/min. The mean eGFR was calculated at 7.64±2.61 ml/min. This data reveals significant variability in kidney function within the studied population.

    §  Ayama (Angula Pramana of rhs), ranging from 71.33 to 99.54 Angula. The mean of Ayama was calculated at 88.11±6.06 Angula. Vistara (Angula Pramana of rhs), ranging from 74.89 to 99.14 Angula. The mean of Vistara was calculated at 89.62±6.46 Angula. 

    §  The difference of Ayama-Vistara (for rhs) ranged from 0 to 5.19 Angula, with a mean of 2.17±1.34 Angula. Which explored the difference between Ayama and Vistara measurements.

    §  Results obtained from two-tailed paired t-test was found significant at p-value <0.0001. This suggests that there are significant differences between the Ayama and Vistara measurements. The t-statistic, was calculated to be 5.188 for the values which was measured in Angula (rhs). These high t-statistic values further emphasize that the differences between Ayama and Vistara measurements are not due to random chance. This indicates that the subjects under the study had poor Bala and Alpa Ayu. This information is important for our research and contributes to a better understanding of the subjects we studied.

    §  The Karl Pearson coefficient of correlation resulted in a correlation coefficient (r) of   -0.6554. This number signified a significant negative relationship and suggests that a higher difference in Ayama-Vistara corresponds to lower eGFR values. The associated p-value was found to be <0.0001. This low p-value tells us that the correlation we observed is not likely due to random chance, indicating a strong statistical relationship between the difference in Ayama-Vistara measurements and eGFR. This relationship is particularly relevant in the context of CKD prognosis. It suggests that as the Ayama-Vistara difference increases, there may be a higher risk of lower eGFR values, which can be indicative of more severe kidney function issues.

    §  In this study three distinct categories with 23, 22 and 5 number of individuals having differences in Ayama and Vistara measurements for assessing the prognosis of CKD with the mean score of eGFR values 9.26, 6.66 and 4.49 individuals having differences in Ayama and Vistara <2 Angula, 2-4 Angula and >4 Angula respectively. These findings indicating that difference in Ayama-Vistara is having significant negative correlation with the prognosis of CKD. So here null hypothesis is rejected and alternative hypothesis is established. This information offers clinicians a valuable tool for treatment planning and enhancing personalized patient care strategies.


 
Close