| CTRI Number |
CTRI/2024/10/075235 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Arishta Lakshan in Ayurveda |
|
Scientific Title of Study
|
An Observational Study Of Arishta Lakshan In Ayurveda With Special Reference To Ominious Signs Of Death In Modern Era. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Ramesh Mauskar |
| Designation |
MD Scholar 2nd Year |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduation Department Of Roganidana Evum Vikruti Vigyana,Shree Swaminarayan Ayurvedic College Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar 382724 India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9834281665 |
| Fax |
|
| Email |
shraddha.mauskar007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S Rao |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduation Department Of Roganidana Evum Vikruti Vigyana,Shree Swaminarayan Ayurvedic College Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar 382724 India
Gandhinagar
GUJARAT
382725
India |
| Phone |
6351047973 |
| Fax |
|
| Email |
provost@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha Ramesh Mauskar |
| Designation |
MD Scholar 2nd Year |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Post Graduation Department Of Roganidana Evum Vikruti Vigyana,Shree Swaminarayan Ayurvedic College Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar 382724 India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9834281665 |
| Fax |
|
| Email |
shraddha.mauskar007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College And Hospital Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar 382725 |
|
|
Primary Sponsor
|
| Name |
Premswarup Swami Ayurvedic MultiSpeciality Hospital Kalol |
| Address |
Shree Swaminarayan Ayurvedic College And Hospital Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar 382725 |
| 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 |
| Shraddha Ramesh Mauskar |
Premswarup Swami Ayurvedic Multi Speciality Hospital |
Post Gradutation Department Of Roganidana Evum Vikruti Vigyana Premswarup Swami Ayurvedic Multi Speciality Hospital Ahemdabad Mehsana Highway At Post Saij Kalol Gandhinagar Gujarat
Gandhinagar
GUJARAT |
9834281665
shraddha.mauskar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , SHREE SWAMINARAYAN AYURVEDIC COLLEGE AND HOSPITAL KALOL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Y999||Unspecified external cause status. Ayurveda Condition: VYADHI-VINISCAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
For this study, all subjects will be carefully chosen from a diverse range of healthcare
settings, including Intensive Care Units (ICU), Cancer hospitals, Burn Wards, Emergency
rooms, and individuals who are elderly and terminally ill, exhibiting conditions such as chronic
illnesses with poor prognoses, associated chronic ailments, and complex diseases. The selection
of subjects will adhere to the diagnostic criteria prescribed by the respective healthcare centres
designated by the university for this research endeavor. |
|
| ExclusionCriteria |
| Details |
For the purpose of this study design, we will exclude and not consider subjects who
have undergone successful chemotherapy and radiation therapy, exhibit a good prognosis for
their disease, are elderly but in good health, or are managing chronic illnesses through ongoing
9
treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate that Arishta lakshan can be used as credible and reliable diagnostic tool for
early diagnosis of residual life in case of chronic illness or terminally ill. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate clinical Arishta lakshan mentioned in Ayurvedic
classics & evaluate non clinical worldly changes as Arishta lakshan
mentioned in Ayurvedic classics. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I Shraddha Ramesh Mauskar. will conduct this trial to evaluate that Arishta lakshan can be used as credible and reliable diagnostic tool for early diagnosis of residual life in case of chronic illness or terminally I’ll.This study seeks to elevate Arishta Lakshan from a mystical practice to a credible diagnostic tool, improving patient outcomes and reducing reliance on costly diagnoses. By bridging tradition and modern science, it offers new possibilities for enhancing patient care. |