| CTRI Number |
CTRI/2025/04/085402 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Knee Pain: Insights from Hospital Treatment Records |
|
Scientific Title of Study
|
Analysis of Treatment Protocols through Hospital Case Records in Patients with Janushool (Knee-joint pain). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayank Tomar |
| Designation |
PG Scholar |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8864854995 |
| Fax |
|
| Email |
mayanktomar943@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital R Rasane |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shital.rasane@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Tomar |
| Designation |
PG Scholar |
| Affiliation |
Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8864854995 |
| Fax |
|
| Email |
mayanktomar943@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Mayank Tomar |
| Address |
Dr. D.Y. Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri colony Pimpri Pune Maharashtra India 411018
Maharashtra
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Mayank Tomar |
Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India 411018 |
Department of Ayurved Samhita Evam Siddhant, Dr. D.Y. Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Colony Pimpri Pune Maharashtra India 411018
Pune
MAHARASHTRA |
8864854995
mayanktomar943@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCARC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M248||Other specific joint derangements,not elsewhere classified. Ayurveda Condition: JANUBEDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Case Record Forms of patients with Janushool (knee-joint pain) enrolled under Kayachikitsa and Panchkarma OPD of the selected hospital within recent one year. |
|
| ExclusionCriteria |
| Details |
Patients of age below 15 years and above 80 years will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By reviewing case records, various treatment protocols in diseases associated with Janushool (knee-joint pain) will be identified which can be helpful in analysing a common treatment protocol for specific diseases, that can lead to streamline treatment processes and serve as a scientific evidence-base for further studies. |
As this is an observational study, the outcome will be assessed at a single time point. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Additionally, by better understanding of various diagnostic techniques physicians employ when treating patients with Janushool (knee-joint pain), the study will aid in the accurate diagnosis of associated disorders. |
As this is an observational study, the outcome will be assessed at a single time point. |
|
|
Target Sample Size
|
Total Sample Size="316"
Sample Size from India="316"
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)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Following approval from the Scientific and Research & Review Committee, a detailed checklist will be prepared to review Case Record Forms (CRFs) of patients diagnosed with Janushool within the past year. With prior permission from hospital authorities, 316 CRFs meeting the inclusion criteria will be selected. The checklist will capture information on diagnostic criteria, treatment protocols, follow-ups, and related clinical data, while ensuring confidentiality of patient details such as name and date of birth. The collected data will be organized using MS Excel and analyzed statistically through appropriate graphical methods. Comparative evaluation of different treatment plans for Janushool will be undertaken. Additionally, open-ended interviews with hospital consultants may be conducted for qualitative insights. The study will conclude with a discussion on the effectiveness of various treatment protocols identified in Janushool cases. |