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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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-Vistaraâ€, 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. |